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June 9, 2023 5:03 am

RH Announces the Unveiling of RH England, the Gallery at the Historic Aynho Park

RH Announces the Unveiling of RH England, the Gallery at the Historic Aynho Park

A Celebration of History, Design, Food and Wine

RH England, The Gallery at the Historic Aynho Park, a Magnificent 17^th-Century, 73-Acre Estate with Architecture and Interiors by Sir John Soane, Restored and Reimagined as First-of-Its-Kind Design and Hospitality Destination.

CORTE MADERA, Calif.–(BUSINESS WIRE)–
RH (NYSE: RH) announced today the opening of RH England, The Gallery at the Historic Aynho Park – a 400-year-old landmark estate representing the most inspiring and immersive physical expression of the brand to date. RH England marks the beginning of the retailer’s global expansion and its continued foray into hospitality with three primary restaurants: The Orangery, a live-fire concept; The Loggia, an outdoor venue featuring wood-fired pizzas; and The Conservatory, an American bistro, opening later this fall. The Gallery also includes a Wine Lounge and Tea Salon – all with stunning views of the English countryside – as well as a Juicery, serving made-to-order fresh juices and grilled baguettes with cultured butter and homemade preserves.

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RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

Spanning 73 acres and over 60 rooms, this unrivaled experience seamlessly integrates luxury home furnishings collections from RH Interiors, Contemporary, Modern and Outdoor with rare art, antiques and artifacts from across the globe. Among England’s rare Grade 1 listed buildings – which include Buckingham Palace and the Houses of Parliament – Aynho Park was expanded and refurbished by preeminent British architect Sir John Soane in the early-19^th century, serving as an exceptional example of his commissioned work for elite clients.

First constructed in 1615, the pedigreed property in the Cotswolds remained in the ownership of the Cartwright family until the mid-20th century. Primarily Classical Revival in style with vestiges of Continental Baroque, Aynho has been meticulously restored and reimagined with great respect for its original vision. RH Chairman & CEO Gary Friedman has revitalized several landmark buildings in North America, including the former Museum of Natural History in Boston, The Historic Three Arts Club in Chicago, The Historic Post Office in Greenwich, Connecticut; the Bethlehem Steel Building in San Francisco, and the company’s Gallery in the historic Meatpacking District in New York.

“We are both proud and humbled to introduce RH to the U.K. in what we hope will be an inspiring and unforgettable fashion, and to fully open Aynho Park to the public for the first time in its history,” said Mr. Friedman. “We believe RH England represents our greatest work to date and will serve as a symbol of our values and beliefs as we embark on our expansion across Europe.”

Set on an elevated plateau at the southern edge of Aynho Village, the vast estate features historic gardens by iconic English landscape architect Capability Brown and mesmerizing views of Europe’s largest herd of White Hart deer.

Guests will first encounter the entrance hall with its Doric colonnades and chimneypiece of Mexican onyx. Designed by Lady Cartwright, the hand-carved fireplace surround was commissioned by Sir Fairfax Cartwright (1857-1928), then British Minister in Mexico. Here, visitors will be greeted by the Aynho Unicorn – a regal mascot symbolizing fantasy, rarity, purity and protection – and concierges dedicated to dining and design who can assist with RH England’s array of services and experiences.

Directly to the south of the entrance hall, guests will find the Salon, a graceful sitting room. Spanning the southern side of the main house is The Grand Viewing Terrace, defined by a layered composition of parasol trees, sculptural evergreens and monolithic limestone fire tables. Set upon the edge of the great lawn, these intimate lounge spaces frame panoramic views of The Deer Park and bucolic landscape beyond.

Venturing west from the Salon, visitors will arrive to what was once the formal dining room – now The Tea Salon, offering afternoon tea service featuring classic specialty teas accompanied by freshly baked scones, clotted cream and house-made preserves – which leads to an antechamber that hosts The Sir John Soane Exhibition.Created in partnership with Sir John Soane’s Museum in London, the exhibit highlights the architect’s life and works at Aynho and other English country houses with meticulous reproductions of original drawings, architectural models and artifacts.

The westward sequence of spaces comes to a dramatic end in The Architecture & Design Library. To create this spectacular destination, Soane transformed a previous single-story wing into an airy, arch-swept center of knowledge. More than two centuries later, RH honors his legacy with a carefully compiled collection of vintage, contemporary and rare out-of-print books from some of the most influential creators of the last 2,000 years.

Commanding the center of the library is the first edition of De Architectura libri Dece (The Ten Books on Architecture), printed in a modern language, Italian, in 1521. Authored by master Roman architect Vitruvius during the 1^st century BC, the treatisehas served as the foundational textbook on classical architecture for centuries. It also serves as the pillar of the RH design ethos – a study of balance, symmetry and perfect proportions. Presiding over the room is an exacting replica of Leonardo da Vinci’s Vitruvian Man – based on Vitruvius’ description of human anatomy written 1,500 years prior – and rare books by the great Renaissancearchitects Alberti, Scamozzi and Palladio, who carried forth the Vitruvian principles.

Anchoring the opposing side of the main house from the library is The Orangery, a live-fire dining experience featuring a marble hearth flanked by custom Molteni rotisseries from France. Aglow in natural light from a wall of towering arched windows, this singular statement space, with its 22-foot ceilings, is punctuated by Calacatta gold marble tables, Italian merino wool velvet seating and a dramatic lighting installation by acclaimed Los Angeles-based master glass designer and artist, Alison Berger – an evocation of rain reflected in an elegant procession of mirrors.

The adjoining Wine Lounge, once the French drawing room, serves exceptional Champagnes and wines from around the world to be enjoyed by the warmth of a 19^th-century rare Rouge Napoleon marble and gilt bronze Louis XV-style fireplace or while exploring the rest of the estate.

To access the beautifully appointed private rooms and suites on the upper levels, visitors will ascend one of two grand staircases, both of which pay tribute to James and Sophie Perkins, Aynho’s previous owners, with their collection of classical sculptures, architectural models and artifacts on display.

Once the stable block, brewhouse and workshop, the east wing will host TheConservatory – an American bistro offering an elevated interpretation of enduring classics – opening fall 2023. This skylit garden escape will be defined by a soaring glass roof supported by structural steelwork, century-old Spanish olive trees, and three monumental salvaged brick fireplaces.

The east wing also houses TheRH Interior Design Studio. Providing an unprecedented level of professional design services,this interactive space features private client presentation rooms, state-of-the-art technology and design libraries showcasing a vast assortment of textiles, furniture and lighting finishes.

Formerly the servants’ quarters, the west wing now presents artistic installations featuring luxury home furnishings collections from internationally renowned designers. Just off this wing, guests will find The Loggia – a restaurant and wine bar offering wood-fired pizzas, charcuterie boards and rustic shared plates in a relaxed outdoor setting with shade canopies, French limestone fountains and fire tables overlooking Capability Brown’s naturalistic landscapes. The adjacent Juicery – previously the site of Aynho’s centuries-old kitchen – serves made-to-order fresh juices, craft espresso and grilled baguettes with cultured butter and homemade preserves to be enjoyed in the organic vegetable garden or while touring the property.

At the estate’s westernmost edge, visitors will discover TheSunset Terrace & Fire Pit – an open-air lounge space, adjacent to an early 19^th-century garden temple, designed as a destination to take in transcendent countryside views.

RH England is located at Aynho Park, Aynho, Banbury and offers valet parking. The phone number is +44 1295 585700. Hours of operation are 11am to 8pm Monday through Saturday, and 11am to 5pm on Sundays.

For more, visit RH.com

ABOUT RH

RH (NYSE: RH) is a curator of design, taste and style in the luxury lifestyle market. The company offers collections through its retail galleries, source books and online at RH.com, RHContemporary.com, RHModern.com, RHBabyandChild.com, RHTEEN.com, and Waterworks.com.

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the following: RH England, The Gallery at the Historic Aynho Park being the most inspiring and immersive physical expression of the brand to date and having an unrivaled experience; the future opening date of The Conservatory; the unprecedented level of professional design service provided by The RH Interior Design Studio; and any statements or assumptions underlying any of the foregoing, and similar statements. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. We cannot assure you that future developments affecting us will be those that we have anticipated. Important risks and uncertainties that could cause actual results to differ materially from our expectations include, among others, risks related to civil unrest; risks related to general economic conditions and the housing market as well as the impact of economic conditions on consumer confidence and spending; changes in customer demand for our products; our ability to anticipate consumer preferences and buying trends; consumer spending based on weather and other conditions beyond our control; risks related to the number of new business initiatives we are undertaking; our ability to obtain our products in a timely fashion or in the quantities required; risks related to our sourcing and supply chain including our dependence on imported products produced by foreign manufacturers and risks related to importation of such products, as well as those risks and uncertainties disclosed under the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in RH’s most recent Form 10-K and Forms 10-Q filed with the Securities and Exchange Commission, and similar disclosures in subsequent reports filed with the SEC, which are available on our investor relations website at ir.rh.com and on the SEC website at www.sec.gov. Any forward-looking statement made by us in this press release speaks only as of the date on which we make it. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230609005062/en/

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KEYWORDS: Europe United States United Kingdom North America California

INDUSTRY KEYWORDS: Luxury Men Home Goods Restaurant/Bar Consumer Lodging Destinations Vacation Tourist Attractions Travel Specialty Public Relations/Investor Relations Food/Beverage Marketing Communications Retail Women

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RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

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RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

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THE GRAND VIEWING TERRACE AT RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

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THE ARCHITECTURE & DESIGN LIBRARY AT RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

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THE ORANGERY AT RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

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THE SIR JOHN SOANE EXHIBITION AT RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

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THE AYNHO UNICORN AT RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

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THE WINE LOUNGE AT RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

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THE TEA SALON AT RH ENGLAND, THE GALLERY AT THE HISTORIC AYNHO PARK (Photo: Business Wire)

Posted on June 9, 2023 3:11 am
Positive Results From Pivotal Trials of exa-cel for Transfusion-Dependent Beta Thalassemia and Severe Sickle Cell Disease Presented at the 2023 Annual European Hematology Association (EHA) Congress

Positive Results From Pivotal Trials of exa-cel for Transfusion-Dependent Beta Thalassemia and Severe Sickle Cell Disease Presented at the 2023 Annual European Hematology Association (EHA) Congress

– Both trials met the primary and key secondary endpoints at the pre-specified interim analysis –

– Data continue to demonstrate transformative and durable benefit –

– Safety profile consistent with busulfan conditioning andautologous hematopoietic stem cell transplant –

BOSTON & ZUG, Switzerland–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced that both pivotal trials for exagamglogene autotemcel (exa-cel) in patients with transfusion-dependent beta thalassemia (TDT) or severe sickle cell disease (SCD) met primary and key secondary endpoints at pre-specified interim analyses. The results are being presented at the Annual European Hematology Association (EHA) Congress.

“The updated results from both the TDT and SCD trials are remarkable and bring the promise of an autologous CRISPR/Cas9 gene-edited cell therapy one-step closer to patients who are waiting,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex.

“This analysis confirms the potential of exa-cel to render patients transfusion-independent or VOC-free, with significant improvement in their quality of life and physical performance,” said Franco Locatelli, M.D., Ph.D., Professor of Pediatrics at the Sapienza University of Rome, Director of the Department of Pediatric Hematology and Oncology at Bambino Gesù Children’s Hospital. “This therapy offers the potential of a functional cure for patients with transfusion-dependent beta thalassemia or severe sickle cell disease along with a favorable safety profile.”

New Data From Pre-Specified Interim Analyses in exa-cel Pivotal Trials

Both CLIMB-111 and CLIMB-121 met their primary endpoint and key secondary endpoint at the pre-specified interim analysis for each trial. These analyses evaluated the efficacy and safety of exa-cel in patients with TDT or SCD in the ongoing Phase 3 trials as well as in the long-term follow up trial CLIMB-131. The data shared are from 83 patients (48 with TDT and 35 with SCD) dosed with exa-cel with follow-up up to 43.7 months. All patients treated with exa-cel demonstrated clinical benefit, and these data continue to demonstrate the potentially transformative profile of exa-cel.

Efficacy of exa-cel in Patients With Transfusion-Dependent Beta Thalassemia

Of the 48 patients with TDT who had received exa-cel at the time of the analysis, more than half (58.3%) have genotypes associated with severe disease, beta-zero/beta-zero or other beta-zero-like severe genotypes. At the time of the data cut, 27 TDT patients were evaluable for the primary and key secondary endpoint.

24/27 (88.9%) achieved the primary endpoint of transfusion-independence for at least 12 consecutive months (TI12) and the secondary endpoint of transfusion-independence for at least 6 consecutive months (TI6) with a mean weighted hemoglobin of at least 9 g/dL (95% CI: 70.8%, 97.6%; P<0.0001). Mean duration of transfusion-independence was 20.5 months with a maximum of 40.7 months.

Of the 3 patients who did not achieve TI12, one patient has since stopped transfusions and has been transfusion-free for 2.9 months; the remaining 2 patients have had substantial reductions (80% and 96%) in transfusion volume from baseline.

Increases in total hemoglobin occurred early within the first few months and were maintained over time. In the analysis of all patients who received exa-cel, mean total hemoglobin was ≥11g/dL at Month 3 and ≥12g/dL from Month 6 onward with pancellular distribution of fetal hemoglobin.

Mean proportion of edited BCL11A alleles was stable over time in bone marrow and peripheral blood indicating successful permanent editing in the long-term hematopoietic stem cells.

Patients also had clinically significant improvements in patient-reported outcomes.

Efficacy of exa-cel in Patients With Severe Sickle Cell Disease

Of the 35 patients with SCD who had received exa-cel at the time of the analysis, 17 patients were evaluable for the primary and key secondary endpoint at the time of the data cut.

16/17 (94.1%) achieved the primary endpoint of freedom from vaso-occlusive crises (VOCs) for at least 12 consecutive months (VF12) (95% CI: 71.3%, 99.9%; P=0.0001). Mean duration of VOC-free was 18.7 months, with a maximum of 36.5 months. 17/17 (100%) achieved the key secondary endpoint of being free from hospitalizations related to VOCs for at least 12 consecutive months (HF12) (95% CI: 80.5%, 100.0%; P<0.0001).

The one patient who did not achieve VF12 did achieve HF12 and has a complex set of comorbidities, including a history of chronic pain.

One patient who achieved VF12 had a VOC 22.8 months following exa-cel infusion in the setting of a parvovirus infection. This patient has since fully recovered from the infection and been VOC-free.

Increases in fetal hemoglobin and total hemoglobin occurred early, within the first few months, and were maintained over time. In the analysis of all patients who received exa-cel, mean fetal hemoglobin was more than 30% of total hemoglobin by Month 3 and was then maintained at approximately 40.0% through follow-up, with pancellular distribution.

Mean proportion of edited BCL11A alleles was stable over time in bone marrow and peripheral blood, indicating successful permanent editing in the long-term hematopoietic stem cells.

Patients also had clinically significant improvements in patient-reported outcomes.

Safety of exa-cel in All Patients

The safety profile of exa-cel was generally consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant. All patients engrafted neutrophils and platelets after exa-cel infusion.

As previously reported, two TDT patients had serious adverse events (SAEs) considered related to exa-cel. One patient had three SAEs considered related to exa-cel: hemophagocytic lymphohistiocytosis (HLH), acute respiratory distress syndrome and headache, and one SAE of idiopathic pneumonia syndrome that was considered related to both exa-cel and busulfan. All four SAEs occurred in the context of HLH in the peri-engraftment period and have resolved. One patient had SAEs of delayed neutrophil engraftment and thrombocytopenia, both of which were considered related to exa-cel and busulfan, and both SAEs have resolved. Among the 35 patients with SCD, there were no SAEs considered related to exa-cel.

Also as previously reported, one adult patient with SCD developed pneumonia and respiratory failure following SARS-CoV-2 infection, resulting in death. The investigator assessed the events as not related to exa-cel. There were no other deaths or discontinuations, and there have been no malignancies in either study.

These data will be shared as outlined below:

Abstract S270 will be an oral presentation entitled “Transfusion Independence and Elimination of Vaso-Occlusive Crises After Exagamglogene Autotemcel For Transfusion-Dependent Βeta-Thalassemia and Severe Sickle Cell Disease,” on Sunday, June 11 at 11:30 CEST. This presentation will include updated pivotal trial data from patients treated with exa-cel in CLIMB-111 and CLIMB-121 and followed in CLIMB‑131. This abstract was chosen for the media briefing program.

In addition, three health economics abstracts from Vertex have been accepted for poster presentation on Friday, June 9 at 18:00 CEST.

Abstract P1452 is entitled “Mortality and Clinical Complications Among Patients With Transfusion-Dependent Beta-Thalassemia in Italy.”

Abstract P1447 is entitled “Mortality and Clinical Complications Among Patients With Sickle Cell Disease With Recurrent Vaso-Occlusive Crises in Italy.”

Abstract P1464 is entitled “Clinical Complications Among Patients With Transfusion-Dependent Beta-Thalassemia in Germany.”

About exagamglogene autotemcel (exa-cel)

Exa-cel is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited cell therapy that is being evaluated for patients with SCD or TDT, in which a patient’s own hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. The elevation of HbF by exa-cel has the potential to reduce or eliminate painful and debilitating VOCs for patients with SCD and alleviate transfusion requirements for patients with TDT. Earlier results from these ongoing trials were published in The New England Journal of Medicine in January of 2021 and presented at the American Society of Hematology Annual Congress in 2022.

Exa-cel has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA for both TDT and SCD. The FDA has accepted the Biologics License Applications (BLAs) for exa-cel and assigned Prescription Drug User Fee Act (PDUFA) action dates of December 8, 2023, for SCD and March 30, 2024, for TDT.

In the EU, exa-cel has been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), for both SCD and TDT. In the U.K., exa-cel has also been granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the Medicines Healthcare products Regulatory Agency (MHRA). In Europe, the Marketing Authorization Applications (MAAs) for exa-cel were submitted in December 2022 and validated by the EMA and MHRA in January 2023.

About CLIMB-111 and CLIMB-121

The ongoing Phase 1/2/3 open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel in patients ages 12 to 35 years with TDT or with SCD, characterized by recurrent VOCs, respectively. The trials are now closed for enrollment. Patients will be followed for approximately two years after exa-cel infusion. Each patient will be asked to participate in CLIMB-131, a long-term follow-up trial.

About CLIMB-131

The ongoing long-term, open-label trial, CLIMB-131, is designed to evaluate the safety and efficacy of exa-cel in patients who received exa-cel in CLIMB-111, CLIMB-121, CLIMB-141, CLIMB-151 or CLIMB-161. The trial is designed to follow participants for up to 15 years after exa-cel infusion.

About CLIMB-141 and CLIMB-151

The ongoing Phase 3 open-label trials, CLIMB-141 and CLIMB-151, are designed to assess the safety and efficacy of a single dose of exa-cel in patients ages 2 to 11 years with TDT or with SCD, characterized by recurrent VOCs, respectively. The trials are now open for enrollment and currently enrolling patients ages 5 to 11 years with the plan to extend to ages 2 to less than 5 years at a later date. Each trial will enroll approximately 15 patients. Patients will be followed for approximately two years after infusion. Each patient will be asked to participate in CLIMB-131, a long-term follow-up trial.

About CLIMB-161

The ongoing Phase 3b trial, CLIMB-161, is to support expansion of our manufacturing footprint after initial potential approval and launch. This trial will enroll approximately 12 patients with either TDT or with SCD, characterized by recurrent VOCs, ages 12 to 35 years. Patients will be followed for approximately one year after infusion. Each patient will be asked to participate in CLIMB-131, a long-term follow-up trial.

About the Gene-Editing Process in These Trials

Patients who enroll in these trials will have their own hematopoietic stem and progenitor cells collected from peripheral blood. The patient’s cells will be edited using the CRISPR/Cas9 technology. The edited cells, exa-cel, will then be infused back into the patient as part of an autologous hematopoietic stem cell transplant (HSCT), a process which involves a patient being treated with myeloablative busulfan conditioning. Patients undergoing HSCT may also encounter side effects (ranging from mild to severe) that are unrelated to the administration of exa-cel. Patients will initially be monitored to determine when the edited cells begin to produce mature blood cells, a process known as engraftment. After engraftment, patients will continue to be monitored to track the impact of exa-cel on multiple measures of disease and for safety.

About the Vertex and CRISPR Collaboration

Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. ‑Exa-cel represents the first potential treatment to emerge from the joint research program. Under an amended collaboration agreement, Vertex now leads global development, manufacturing and commercialization of exa-cel and splits program costs and profits worldwide 60/40 with CRISPR Therapeutics.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust clinical pipeline of investigational small molecule, mRNA, cell and genetic therapies (including gene editing) in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes and alpha-1 antitrypsin deficiency.

Founded in 1989 in Cambridge, Mass., Vertex’s global headquarters is now located in Boston’s Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry’s top places to work, including 13 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

(VRTX-GEN)

Vertex Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements made by Carmen Bozic, M.D., and Franco Locatelli, M.D., Ph.D., in this press release, our expectations for the therapeutic value of exa-cel, our plans and expectations to present updated clinical data for exa-cel at EHA, our plans for additional abstracts for poster presentation and publication at EHA, the status of our clinical trials of our product candidates under development by us and our collaborators, including activities at the clinical trial sites, the gene-editing process, patient enrollment and expectations regarding clinical trial follow-up. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from a limited number of patients may not be indicative of final clinical trial results, that regulatory authorities may not approve, or approve on a timely basis, the exa-cel applications, that data from the company’s development programs, including its programs with its collaborators, may not support registration or further development of its compounds due to safety, efficacy or other reasons, that internal or external factors that could delay, divert, or change our plans and objectives with respect to our exa-cel program, that future competitive or other market factors may adversely affect the commercial potential for exa-cel, and other risks listed under the heading “Risk Factors” in Vertex’s most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission (SEC) and available through the company’s website at www.vrtx.com and on the SEC’s website at www.sec.gov. You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(CRSP-GEN)

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. For more information, please visit www.crisprtx.com.

CRISPR THERAPEUTICS^® word mark and design are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

CRISPR Therapeutics Forward-Looking Statement

This press release may contain a number of “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements made by Carmen Bozic, M.D., and Franco Locatelli, M.D., Ph.D., in this press release, as well as statements regarding CRISPR Therapeutics’ expectations about any or all of the following: i) the safety, efficacy and clinical progress of the ongoing exa-cel clinical trials, including expectations regarding the clinical data being presented, the therapeutic value of exa-cel, and our plans to present the clinical data during the EHA Congress;and (ii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects” and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, existing and prospective investors are cautioned that forward-looking statements are inherently uncertain, are neither promises nor guarantees and not to place undue reliance on such statements, which speak only as of the date they are made. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential that data from a limited number of patients may not to be indicative of final or future clinical trial results; the potential that the exa-cel clinical trial results may not be favorable or may not support registration or further development; that future competitive or other market factors may adversely affect the commercial potential for exa-cel; CRISPR Therapeutics may not realize the potential benefits of its collaboration with Vertex; uncertainties regarding the intellectual property protection for CRISPR Therapeutics’ technology and intellectual property belonging to third parties; and those risks and uncertainties described under the heading “Risk Factors” in CRISPR Therapeutics’ most recent annual report on Form 10-K, quarterly report on Form 10-Q, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230609005104/en/

Vertex Pharmaceuticals Incorporated

Investors:

Susie Lisa, +1 617-341-6108

Or

Manisha Pai, +1 617-961-1899

Or

Miroslava Minkova, +1 617-341-6135

Media:

[email protected]

or

U.S.: +1 617-341-6992

or

Heather Nichols: +1 617-839-3607

or

International: +44 20 3204 5275

CRISPR Therapeutics

Investors:

Susan Kim, +1 617-307-7503

[email protected]

Media:

Rachel Eides, +1-617-315-4493

[email protected]

KEYWORDS: Europe Switzerland United States North America Massachusetts

INDUSTRY KEYWORDS: Stem Cells Biometrics Biotechnology Pharmaceutical General Health Health Genetics Clinical Trials

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Posted on June 9, 2023 3:09 am
Genmab Showcases Data From Comprehensive Epcoritamab Development Program in Patients Across B-Cell Lymphomas at European Hematology Association (EHA) Annual Meeting 2023

Genmab Showcases Data From Comprehensive Epcoritamab Development Program in Patients Across B-Cell Lymphomas at European Hematology Association (EHA) Annual Meeting 2023

Results fromphase 1/2 EPCORE™ NHL-2 trial investigating epcoritamab in combination with rituximab-lenalidomide (R2) showed a 98 percent overall response rate (ORR), 87 percent complete metabolic response (CMR) in patients with relapsed or refractory (R/R) follicular lymphoma (FL)

Results from the EPCORE™ NHL-1 expansion cohort, including longer follow-up in challenging-to-treat large B-cell lymphoma (LBCL) patients, also presented

First patients dosed in phase 3 EPCORE™ DLBCL-2 and phase 2 EPCORE™ DLBCL-3 trials demonstrates ongoing commitment to further evaluating epcoritamab

COPENHAGEN, Denmark–(BUSINESS WIRE)–Genmab A/S (Nasdaq: GMAB) today announced data from its ongoing phase 1/2 EPCORE™ NHL-2 trial investigating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab-lenalidomide (R2) showed an overall response rate (ORR) of 98 percent and complete metabolic response (CMR) of 87 percent in response evaluable patients (n=104) with relapsed or refractory (R/R) follicular lymphoma (FL). These preliminary results will be presented today during an oral presentation at the 2023 European Hematology Association (EHA) Congress, being held in Frankfurt, Germany and virtually, June 8-11, 2023 (Abstract #S222). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV) as part of the companies’ oncology collaboration.

Additional findings from the study observed consistent ORR and CMR across high-risk subgroups, including a 98 percent ORR and a 75 percent CMR in patients whose disease progressed within 24 months (POD24, n=40), a 95 percent ORR and 75.7 percent CMR in patients who were double refractory (refractory to both an anti-CD20 and an alkylating agent, n=37), a 100 percent ORR and 83.8 percent CMR in patients who were primary refractory (no response or relapse within six months after first-line treatment, n=37), and a 96 percent ORR and 80.9 percent CMR in patients refractory to prior anti-CD20 treatment (n=47). Median time to any response and CMR was 1.4 months. Estimated nine-month progression-free survival was 85 percent.

“Follicular lymphoma is a challenging cancer where disease progression within two years of initial treatment with chemoimmunotherapy, known as POD24, occurs in approximately 20 percent of patients and is a strong predictor of poor outcomes. Currently, there is no standard treatment approach for patients with high-risk, relapsed or refractory follicular lymphoma, including POD24,” said Anna Sureda, MD, PhD, Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d’Oncologia, IDIBELL, Universitat de Barcelona, L’Hospitalet de Llobregat, Barcelona, Spain. “The results being presented today are encouraging and warrant further evaluation of epcoritamab in combination with R2 in this patient population to determine if this combination could potentially be offered as a treatment option for patients in need of alternative therapeutic options.”

Among the 111 patients in the safety analysis, the most common treatment emergent adverse events (TEAE) were neutropenia (57 percent) and cytokine release syndrome (CRS) (48 percent), injection-site reactions (41 percent), and fatigue (36 percent). CRS events were mostly low grade (G1-2, 46 percent; G3, 2 percent) and mostly occurred following the first full dose (cycle 1, day 15). All events resolved and none led to treatment discontinuation. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in two patients (G1, G2) and resolved. Results from this study were also presented at this year’s American Society of Clinical Oncology (ASCO) Meeting on June 6, 2023.

“Together with AbbVie, through our comprehensive clinical development program, we remain committed to evaluating epcoritamab, alone or in combination with other therapies, as a potential treatment option across a variety of people affected by hematologic cancers,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “The data being presented at EHA demonstrate our shared commitment to develop epcoritamab as a potential core therapy for B-cell malignancies.”

Additional Data Evaluating Epcoritamab

A poster presentation (Abstract #1118) at EHA featured updated results from the EPCORE NHL-1 large B-cell lymphoma (LBCL) expansion cohort, including longer follow-up (median follow up was 20 months) in challenging-to-treat, relapsed or refractory CD20+ LBCL patients. Of the 157 patients with R/R LBCL, including diffuse large B-cell lymphoma (DLBCL) and high grade B-cell lymphoma (HGBCL) (n=148), Primary mediastinal large B-cell lymphoma (PMBCL [n=4]), and FL (n=5), 36 remain on treatment. Results from the trial showed an overall response (OR) of 63.1 percent and complete response (CR) of 39.5 percent in patients with R/R LBCL and a 61.9 percent OR and 39.6 percent CR in patients with R/R DLBCL. The median overall survival (OS) was 18.5 months for LBCL patients and 19.4 months for DLBCL patients. The median duration of CR in both patient populations was 20.8 months. OS was not reached among complete responders in both patient populations.

The most common TEAEs of any grade (G) were CRS (51 percent), neutropenia (24 percent), pyrexia (24 percent), fatigue (23 percent), nausea (22 percent), and diarrhea (21 percent). Nine patients (6 percent) had G1–2 ICANS, and one patient had a G5 ICANS with confounding factors.

Demonstrating the company’s commitment to evaluating the potential of epcoritamab in earlier lines of therapy, the first patients have been dosed in the phase 3 EPCORE DLBCL-2 (NCT: 05578976) and phase 2 EPCORE DLBCL-3 (NCT: 05660967) trials, designed to evaluate the safety and efficacy of epcoritamab as first-line treatment in adult and elderly patients with newly diagnosed DLBCL, respectively. The safety and efficacy of epcoritamab for first-line treatment in DLBCL has not been established.

About the EPCORE NHL-2 Study

EPCORE NHL-2 isa phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab in combination with other standard of care agents in patients with B-cell non-Hodgkin lymphoma, including FL. In arms 2a and 2b of the EPCORE NHL-2 trial, 111 patients with R/R CD20+ FL received subcutaneous epcoritamab 48mg + R2 for 12 cycles (28 days each). Epcoritamab was dosed once weekly in cycles 1–3, once every two weeks in cycles 4–9, and once every four weeks in cycles ≥10 (2a) or once weekly in cycles 1–2 and once every four weeks in cycles ≥3 (2b) for ≤2 years.

Baseline characteristics included 58 percent of patients who had Follicular Lymphoma International Prognostic Index (FLIPI) 3–5, 60 percent who had stage IV disease, and 57 percent who had received only one prior line of treatment. Most had received alkylating agents (92 percent) or anthracyclines (63 percent); two had received prior CAR T therapy. The data being presented at EHA represent a pooled analyses from arms 2a and 2b of the EPCORE NHL-2 trial evaluating epcoritamab in combination with R2 in patients with R/R FL.

About Follicular Lymphoma (FL)

FL is typically an indolent (or slow growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.ⁱ FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases, and represents 10-20 percent of all lymphomas in the western world.^ii,iii Although FL is an indolent lymphoma, it is considered incurable with conventional therapy.^iv,v

About Large B-cell Lymphoma (LBCL)

LBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally.^vi

About Epcoritamab

Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody^® technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T-cells and CD20 on B-cells and induces T-cell mediated killing of CD20+ cells.^vii

Epcoritamab-bysp (EPKINLY™) was recently approved in the United States and is indicated for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after two or more lines of systemic therapy.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In October 2022, a Marketing Authorization Application was submitted for epcoritamab for the treatment of patients with R/R DLBCL after two or more lines of systemic therapy, which was validated by the European Medicines Agency. Additionally, in December 2022, a Japan new drug application was submitted to the Ministry of Health, Labor and Welfare of Japan for epcoritamab for the treatment of patients with R/R LBCL after two or more lines of systemic therapy. Epcoritamab is not approved in the European Union and Japan. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets excluding the U.S. and Japan throughout the year.

Genmab and AbbVie are continuing to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494), an ongoing phase 3, open-label, randomized trial evaluating epcoritamab in combination in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label clinical trial evaluating epcoritamab in combination in patients with R/R follicular lymphoma (FL) (NCT: 05409066). Epcoritamab is not approved to treat newly diagnosed patients with DLBCL or FL. The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY (epcoritamab-bysp). Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.

Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

Cytokine Release Syndrome (CRS)

EPKINLY can cause CRS, including serious or life-threatening reactions. CRS occurred in 51 percent of patients at the recommended dose in the clinical trial (37 percent grade 1, 17 percent grade 2, and 2.5 percent grade 3). Recurrent CRS occurred in 16 percent of patients. Of all the CRS events, most (92 percent) occurred during cycle 1. In cycle 1, 9 percent of CRS events occurred after the 0.16 mg dose (cycle 1, day 1), 16 percent after the 0.8 mg dose (cycle 1, day 8), 61 percent after the 48 mg dose (cycle 1, day 15), and 6 percent after the 48 mg dose (cycle 1, day 22). The median time to onset of CRS from the most recently administered EPKINLY dose across all doses was 24 hours (range, 0-10 days). The median time to onset after the first full 48 mg dose was 21 hours (range, 0-7 days). CRS resolved in 98 percent of patients; the median duration of CRS events was 2 days (range, 1-27 days).

Signs and symptoms of CRS can include pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in 2.5 percent of patients and included headache, confusional state, tremors, dizziness, and ataxia.

Initiate EPKINLY according to the step-up dosing schedule. Administer pretreatment medications to reduce the risk of CRS and monitor patients for potential CRS. Following administration of the first 48 mg dose, patients should be hospitalized for 24 hours. At the first signs or symptoms of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care as appropriate. Withhold or discontinue EPKINLY based on the severity of CRS.

Patients who experience CRS (or other adverse reactions that impair consciousness) should be evaluated and advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.

Immune Effector Cell–Associated Neurotoxicity Syndrome (ICANS)

EPKINLY can cause life-threatening and fatal ICANS. ICANS occurred in 6 percent (10/157) of patients in the clinical trial (4.5 percent grade 1, 1.3 percent grade 2, 0.6 percent fatal: 1 event). Of the 10 ICANS events, 9 occurred in cycle 1 of treatment. The median time to onset was 16.5 days (range, 8-141 days) from the start of treatment. Relative to the most recent administration, the median time to onset was 3 days (range, 1-13 days). The median duration of ICANS was 4 days (range, 0-8 days), with ICANS resolving in 90 percent of patients with supportive care.

Signs and symptoms of ICANS can include confusional state, lethargy, tremors, dysgraphia, aphasia, and nonconvulsive status epilepticus. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Monitor for potential ICANS. At the first signs or symptoms of ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or discontinue EPKINLY per recommendations and consider further management per current practice guidelines.

Patients who experience signs or symptoms of ICANS or any other adverse reactions that impair cognition or consciousness should be evaluated, including potential neurology evaluation, and patients at increased risk should be advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.

Infections

EPKINLY can cause serious and fatal infections. In the clinical trial, serious infections, including opportunistic infections, were reported in 15 percent of patients treated with EPKINLY at the recommended dose (14 percent grade 3 or 4, 1.3 percent fatal). The most common grade 3 or greater infections were sepsis, COVID-19, urinary tract infection, pneumonia, and upper respiratory tract infection.

Monitor patients for signs and symptoms of infection prior to and during treatment with EPKINLY and treat appropriately. Avoid administration of EPKINLY in patients with active infections.

Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis and consider prophylaxis against herpes virus.

Withhold or consider permanent discontinuation of EPKINLY based on severity.

Cytopenias

EPKINLY can cause serious or severe cytopenias, including neutropenia, anemia, and thrombocytopenia. Among patients who received the recommended dose in the clinical trial, grade 3 or 4 events occurred in 32 percent (decreased neutrophils), 12 percent (decreased hemoglobin), and 12 percent (decreased platelets). Febrile neutropenia occurred in 2.5 percent.

Monitor complete blood counts throughout treatment. Based on severity of cytopenias, temporarily withhold or permanently discontinue EPKINLY. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.

Embryo-Fetal Toxicity

EPKINLY may cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY. Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose.

Adverse Reactions

The most common (≥20 percent) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. The most common grade 3 to 4 laboratory abnormalities (≥10 percent) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.

Lactation

Advise women not to breastfeed during treatment and for 4 months after the last dose of EPKINLY.

Please see the full Prescribing Information and Medication Guide, including Boxed Warnings.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.

This Media Release contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.comand the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; DuoBody in combination with the DuoBody logo^®; HexaBody^®;^{HexaBody in combination with^{the HexaBody logo^®; DuoHexaBody^® and HexElect^®. EPCORE™ and EPKINLY™ are owned by AbbVie Biotechnology Ltd.}}

ⁱ Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed June 2023.

ⁱⁱMa S. Risk factors of follicular lymphoma. Expert Opin Med Diagn. 2012;6:323–33. doi: 10.1517/17530059.2012.686996.

ⁱⁱⁱ Luminari S, Bellei M, Biasoli I, Federico M. Follicular lymphoma—treatment and prognostic factors. Rev Bras Hematol Hemoter. 2012;34:54–9. doi: 10.5581/1516-8484.20120015.

^iv Link BK, et al. Second-Line and Subsequent Therapy and Outcomes for Follicular Lymphoma in the United States: Data From the Observational National LymphoCare Study. Br J Haematol 2019;184(4):660-663.

^vRen J, et al. Economic Burden and Treatment Patterns for Patients With Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in the USA. J Comp Eff Res 2019;8(6):393-402.

^vi Sehn, Salles. “Diffuse Large B-Cell Lymphoma.” N Engl J Med. 2021;384:842-858. DOI: 10.1056/NEJMra2027612.

^vii Engelberts et al. “DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing.” EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625

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David Freundel, Senior Director, Communications

T: +1 609 613 0504; E: [email protected]

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: [email protected]

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INDUSTRY KEYWORDS: Science Other Science Biotechnology Research Pharmaceutical General Health Health Clinical Trials

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Posted on June 9, 2023 3:08 am
BeiGene Highlights Promising Data from Blood Cancer Portfolio and Pipeline at the European Hematology Association Hybrid Congress

BeiGene Highlights Promising Data from Blood Cancer Portfolio and Pipeline at the European Hematology Association Hybrid Congress

– New follow-up results from Phase 3 SEQUOIA trial and post hoc safety analyses for BRUKINSA^® (zanubrutinib) reinforce potential across various B-cell malignancies

– Early results for BTK-targeted CDAC (BGB-16673) and BCL-2 inhibitor (BGB-11417) in various B-cell malignancies illustrate promise of pipeline

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235),a global biotechnology company, today announced the presentation of new data from its broad blood cancer portfolio of approved therapies and promising early-stage pipeline products at the 2023 European Hematology Association (EHA) Hybrid Congress. BeiGene has ten accepted abstracts at EHA, which is taking place from June 8-11 in Frankfurt, Germany.

“We are excited to share the latest research from our robust hematology portfolio and pipeline, including new results that further deepen our understanding of BRUKINSA across a number of hematologic malignancies,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “These data underscore our ongoing commitment to delivering treatments that have the potential to improve the lives of those living with blood cancers.”

Expanding the Evidence Base for BRUKINSA

With extended follow-up from the pivotal, Phase 3 SEQUOIA study, BRUKINSA remains an important frontline treatment option for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BRUKINSA continued to demonstrate clinically meaningful efficacy in patients with treatment-naïve CLL/SLL without del(17p). In addition to the previously reported benefit in patients with the unmutated immunoglobulin heavy chain (IGHV) gene, longer follow-up now shows benefit in those with mutated IGHV as well, and patients with del(17p) continue to demonstrate progression-free survival (PFS) benefit consistent with the randomized cohort. BRUKINSA continues to be well tolerated over time, with low rates of treatment discontinuation. (Abstract #P639)

In post-hoc analyses, safety data were pooled from ten clinical trials of BRUKINSA monotherapy in patients with certain B-cell malignancies, including from the Phase 3 ASPEN and ALPINE trials, which compared BRUKINSA head-to-head with ibrutinib. These pooled safety analyses demonstrate that BRUKINSA is generally well tolerated, as BRUKINSA adverse events were generally mild-to-moderate in severity and tended not to lead to treatment discontinuation. Prevalence of adverse events of special interest (AESI) generally trended down over time without emergence of new safety signals, supporting BRUKINSA as a viable long-term treatment option. (Abstract #P631)

In an updated safety and efficacy analysis of BRUKINSA in patients with various B-cell malignancies, results showed that switching to BRUKINSA may provide clinical benefit to patients previously intolerant of ibrutinib and/or acalabrutinib. In total, 82 patients were evaluated (61 CLL/SLL, 13 Waldenström’s macroglobulinemia, 4 mantle cell lymphoma, 4 marginal zone lymphoma). (Abstract #P633)

Additionally, in an updated analysis of the Phase 2 ROSEWOOD study, BRUKINSA plus obinutuzumab, a humanized type II anti-CD20 monoclonal antibody, demonstrated clinically meaningful activity and manageable safety profile in patients with heavily pretreated relapsed/refractory (R/R) follicular lymphoma (FL). The European Medicines Agency recently validated BeiGene’s Type II variation application for BRUKINSA for the treatment of adult patients with R/R FL. (Abstract #P1080)

BeiGene’s Promising Early Pipeline in Hematology

BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK)-targeting chimeric degradation activation compound (CDAC) that is designed to be a potent inhibitor against tumors expressing wildtype and clinically relevant BTK mutations. The investigative molecule is currently being evaluated in Phase 1 trials (NCT05006716, NCT05294731). The preclinical findings presented at EHA suggest BGB-16673 is a promising next-generation BTK inhibitor that could benefit patients who developed BTKi on-target resistant mutations. (Abstract #P1219)

Additionally, in an encore presentation from the American Society of Clinical Oncology Annual Meeting, BGB-11417, a potent and highly selective BCL-2 inhibitor, showed promising initial efficacy results in relapsed/refractory CLL/SLL, with patients achieving responses at lower dose levels. (Abstract #P626)

About BRUKINSA^® (zanubrutinib)

BRUKINSA is a small molecule inhibitor of BTK discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 4,900 subjects in 35 trials across 29 markets. To date, BRUKINSA is approved in more than 65 markets around the world, including the United States, China, the European Union, Great Britain, Canada, Australia, South Korea, and Switzerland.

About BGB-16673

BGB 16673 is an orally available BTK targeting CDAC designed to degrade wildtype BTK and multiple mutant forms. It is currently under phase 1 clinical investigations (NCT05006716, NCT05294731).

About BGB-11417

BGB-11417 is an investigational small molecule BCL-2 inhibitor. Preclinical and IND-enabling studies of BGB-11417 have demonstrated potent activity and high selectivity against the pro-apoptotic protein BCL-2. The molecule is more selective than venetoclax for BCL-2 relative to BCL-xL and shows the potential to overcome resistance to venetoclax.

About BeiGene

BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 9,400 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

U.S. IMPORTANT SAFETY INFORMATION FOR BRUKINSA (zanubrutinib)

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage, including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.6% of patients treated with BRUKINSA monotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 30% of patients.

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 24% of patients, most commonly pneumonia (11%), with fatal infections occurring in 2.9% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (22%), thrombocytopenia (8%) and anemia (7%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 11% of patients, and Grade 4 thrombocytopenia occurred in 2.8% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 13% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer reported in 7% of patients. Other second primary malignancies included malignant solid tumors (5%), melanoma (1.2%), and hematologic malignancies (0.5%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 3.7% of 1550 patients treated with BRUKINSA monotherapy, including Grade 3 or higher cases in 1.7% of patients. Patients with cardiac risk factors, hypertension and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients.

Monitor for signs and symptoms for cardiac arrhythmias (e.g. palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

The most common adverse reactions (≥30%), including laboratory abnormalities, included decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

Specific Populations

Lactation: Advise not to breastfeed.

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

INDICATIONS

BRUKINSA is indicated for the treatment of adult patients with

chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Waldenström’s macroglobulinemia (WM)

Mantle cell lymphoma (MCL) who have received at least one prior therapy.

Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

The MCL and MZL indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see full U.S. Prescribing Informationincluding U.S. Patient Information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the strength of BeiGene’s blood cancer portfolio and pipeline; the potential for BeiGeneto deliver treatments that have the potential to improve the lives of those living with blood cancers; the potential for BRUKINSA to be an important frontline treatment option for CLL or SLL; the general future of BeiGene’s pipeline and programs; BeiGene’s advancement, anticipated clinical development, regulatory milestones and commercialization of BGB-11417, BGB-16673, and zanubrutinib; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; and the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230609005039/en/

Investor Contact:

Kevin Mannix

+1 240-410-0129

[email protected]

Media Contact:

Maryline Iva

+ 41 61 685 2090

[email protected]

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Posted on June 9, 2023 3:06 am
Kymera Therapeutics Presents Data Demonstrating Superior Efficacy of KT-253, a Potent and Selective Heterobifunctional MDM2 Degrader, Compared to Small Molecule Inhibitor in Preclinical Leukemia Models at the European Hematology Association Congress

A single dose of KT-253 drives tumor regression and demonstrates differentiated pharmacology compared to small molecule inhibitor (SMI) in preclinical models of ALL and AML

WATERTOWN, Mass., June 09, 2023 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, will present preclinical data on KT-253, a potent and selective heterobifunctional MDM2 degrader. The data will be presented at the European Hematology Association (EHA) Congress, taking place from June 8-15, 2023, in Frankfurt, Germany.

KT-253 targets MDM2, the crucial regulator of the most common tumor suppressor, p53. p53 remains intact (wild type) in close to 50% of cancers, meaning that it retains its ability to modulate cancer cell growth. While small molecule inhibitors (SMIs) have been developed to stabilize and upregulate p53 expression, they have been found to induce a feedback loop that increases MDM2 protein levels, which can repress p53 and limit their efficacy. In preclinical studies, KT-253 has shown the ability to overcome the MDM2 feedback loop and rapidly induce cancer cell death with brief exposures, providing the opportunity for an improved efficacy and safety profile.

New results show that a single, high dose of KT-253 administered intravenously (IV) in preclinical models of acute lymphoblastic leukemia (RS4;11 ALL) and acute myeloid leukemia (MV4;11 AML) led to >90% MDM2 degradation in tumors within one hour of dosing, strong p53 upregulation and induction of apoptosis within the first 8-24 hours, and sustained tumor regressions. In contrast, lower doses of KT-253 administered IV more frequently or repeat dosing with an oral MDM2 SMI led only to relatively weak p53 activation and apoptosis induction and modest tumor growth inhibition. These results suggest that a pulse IV dosing regimen of KT-253 has the potential for an improved efficacy and safety profile over MDM2 SMIs currently in the clinic.

“KT-253 exemplifies our approach of selecting targets with strong genetic validation where we believe that targeted protein degradation provides the best chance for an effective treatment. These findings in models of AML and ALL demonstrate that acute and potent MDM2 degradation with IV pulse dosing of KT-253 enables the most effective upregulation of the p53 pathway in vulnerable p53 wild-type tumor cells while limiting the duration of pathway modulation in normal cells, thereby potentially improving the therapeutic index for MDM2 targeting,” said Nello Mainolfi, Ph.D., Founder, President and CEO, Kymera Therapeutics. “This hit-and-run approach with our MDM2 degrader has the potential to overcome the inherent limitations of small molecule MDM2 inhibitors against this promising target, and we look forward to investigating the activity of KT-253 in a variety of liquid and solid tumors in our ongoing clinical studies.”

Presentation at EHA:

Title: Pulse Dosing of Potent and Selective Heterobifunctional MDM2 Degrader KT-253 Drives Tumor Regression and Demonstrates Differentiated Pharmacology Compared to p53/MDM2 Small Molecule Inhibitors

Abstract Number: P464

Session Time: 6:00 PM – 7:00 PM CEST, June 9, 2023

Presenter: Nancy Dumont, Director, In Vivo Pharmacology‌, Kymera Therapeutics

MDM2 Degrader Program (KT-253)

The KT-253 Phase 1 trial initiated in March 2023 will evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics, and clinical activity of KT-253 in patients with relapsed or refractory high grade myeloid malignancies, including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), lymphoma and solid tumors. Patients in the KT-253 Phase 1 dose escalation study will receive IV doses of KT-253 administered once every 3 weeks. The open-label study is intended to identify the recommended Phase 2 dose for KT-253, and is comprised of two arms, with ascending doses of KT-253 in each arm. The first arm will consist of patients with lymphomas and advanced solid tumors and the second arm will consist of patients with high grade myeloid malignancies and ALL.

More information on the Phase 1 study can be found at www.clinicaltrials.gov, identifier NCT05775406.

About Kymera Therapeutics

Kymera is a biopharmaceutical company pioneering the field of targeted protein degradation, a transformative approach to address disease targets and pathways inaccessible with conventional therapeutics. Kymera’s Pegasus platform is a powerful drug discovery engine, advancing novel small molecule programs designed to harness the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. With a focus on undrugged nodes in validated pathways, Kymera is advancing a pipeline of novel therapeutic candidates designed to address the most promising targets and provide patients with more effective treatments. Kymera’s initial programs target IRAK4, IRAKIMiD, and STAT3 within the IL-1R/TLR or JAK/STAT pathways, and the MDM2 oncoprotein, providing the opportunity to treat patients with a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors.

Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a “Fierce 15” company by Fierce Biotech and has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston’s top workplaces. For more information about our people, science, and pipeline, please visit www.kymeratx.com or follow us on Twitter or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements by Kymera Therapeutics regarding its: strategy, business plans and objectives for the MDM2 degrader program; plans and timelines for the preclinical and clinical development of KT-253, including the therapeutic potential, clinical benefits and safety thereof; expectations regarding timing and, success and data announcements of current ongoing preclinical and clinical trials. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 or any future pandemics on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of Kymera Therapeutics’ drug candidates; the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for KT-474, KT-333, KT-413 and KT-253; Kymera Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Kymera Therapeutics’ planned interactions with regulatory authorities; obtaining, maintaining and protecting its intellectual property; and Kymera Therapeutics’ relationships with its existing and future collaboration partners. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 filed on May 4, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Kymera Therapeutics’ subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Kymera Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Kymera Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Contact: 
 
Bruce Jacobs 
Chief Financial Officer 
[email protected]
857-285-5300 
 
Chris Brinzey 
Managing Director, Westwicke 
[email protected]
339-970-2843  Media Contact: 
 
Todd Cooper 
Senior Vice President, Corporate Affairs 
[email protected]
857-285-5300 
 

Posted on June 9, 2023 3:04 am
Editas Medicine Announces Positive Initial EDIT-301 Safety and Efficacy Data from the First Four Patients Treated in the RUBY Trial and the First Patient Treated in the EdiTHAL Trial

EDIT-301 was well-tolerated and demonstrated a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant

First two RUBY patients achieved normal levels of total hemoglobin and fetal hemoglobin of >40% at 5 months and maintained these levels after 10 and 6 months of follow up

All five patients treated with EDIT-301 successfully engrafted and all four RUBY patients treated are free of vaso-occlusive events since infusion

RUBY clinical data to be presented at the European Hematology Association (EHA) Hybrid Congress on Saturday, June 10, at 5:30 p.m. CET/11:30 a.m. ET

Company to host a

virtual event

on the RUBY and EdiTHAL data on Monday, June 12 at 8:00 a.m. ET

CAMBRIDGE, Mass., June 09, 2023 (GLOBE NEWSWIRE) — Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome editing company, today announced positive initial safety and efficacy data from the first four patients with sickle cell disease (SCD) treated with EDIT-301 in the RUBY trial and from the first transfusion-dependent beta thalassemia patient treated in the EdiTHAL trial.

The RUBY trial data will be presented in an oral presentation at European Hematology Association (EHA) Hybrid Congress in Frankfurt, Germany, and via live stream on Saturday, June 10, at 5:30 p.m. CEST/11:30 a.m. EDT. Editas Medicine will present the RUBY trial data and the EdiTHAL trial data on Monday, June 12, at 8 a.m. ET in a Company-sponsored webinar.

In the RUBY trial, Patients 1 and 2 reached normal hemoglobin levels five months post-treatment with EDIT-301, and both patients have maintained a normal hemoglobin level at ten- and six-month follow-up, respectively. Additionally, each of these patients has seen fetal hemoglobin levels of greater than 40% persist during the same time frame. Patients 3 and 4 in the RUBY trial saw increases in total hemoglobin and fetal hemoglobin at three and two months of follow up, respectively, that follow similar trajectories as those seen in the first two patients. All four treated RUBY patients are also free of vaso-occlusive events (VOEs) since infusion.

In the EdiTHAL trial, the first patient demonstrated successful neutrophil and platelet engraftment, and, at one and a half months post-infusion, the patient’s response resembles that of the first four RUBY patients.

EDIT-301 was well-tolerated and demonstrated a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by the four patients in the RUBY trial and the first patient in the EdiTHAL trial. After EDIT-301 infusion, no serious adverse events occurred, and no adverse events reported were related to treatment with EDIT-301.

RUBY Trial

Safety

All treated patients demonstrated successful neutrophil and platelet engraftment. No serious adverse events (SAEs) were reported after EDIT-301 infusion, and no adverse events (AEs) related to EDIT-301 treatment have been observed. All four treated patients in the RUBY trial are free from vaso-occlusive events since infusion with EDIT-301, with 2-10 months follow-up.

Efficacy

Patient 1 (male) has had 10 months of follow-up. Patient 1’s total hemoglobin returned to normal physiological level of 16.4g/dL (male normal range: 13.6–18.0 g/dL) at five months after infusion of EDIT-301 and has been maintained at this level at the 10-month follow-up. In addition, Patient 1’s fetal hemoglobin fraction increased from 5% at baseline to 45.4% five months after treatment with EDIT-301 and 43.4% at the 10-month follow-up.

Patient 2 (female) has had 6 months of follow-up. Patient 2’s total hemoglobin reached normal physiological level of 12.7 g/dL (female normal range: 12.0–16.0 g/dL) at five months after infusion of EDIT-301 and fetal hemoglobin increased from 10.8% at baseline to 51.3% at the 6-month follow-up.

Patient 3 (female) and Patient 4 (male) have had three and two months of follow-up, respectively. Increases in total hemoglobin and fetal hemoglobin fractions for Patient’s 3 and 4 are following similar trajectories as seen in Patients 1 and 2 at the same timepoints.

EdiTHAL Trial

Safety

The first treated patient (male) in the EdiTHAL trial has had 1.5 months of follow-up. Patient 1 had successful neutrophil and platelet engraftment within 30 days of EDIT-301 infusion, and the safety profile has been consistent with that of myeloablative busulfan conditioning and autologous hematopoietic stem cell transplant. No serious adverse events occurred after EDIT-301 infusion, and no adverse events reported were related to treatment with EDIT-301.

Efficacy

The first EdiTHAL patient’s experience with EDIT-301 resembles that of the first four RUBY patients, achieving a fetal hemoglobin fraction of 34.9% representing 4 g/dL of total hemoglobin at 1.5 months post-treatment.

“These promising data support our belief that EDIT-301 can be a clinically differentiated, one-time, durable medicine that can provide life changing clinical benefits to patients with sickle cell disease and beta thalassemia long term, specifically driving early and robust correction of anemia and sustained increases in fetal hemoglobin,” said Baisong Mei, MD, Ph.D., Senior Vice President and Chief Medical Officer, Editas Medicine. “I would like to thank the clinical trial participants, their families, clinicians, and colleagues at collaborating institutions that contribute to the RUBY and EdiTHAL trials. We remain on-track to dose 20 RUBY patients by year-end, and we look forward to sharing further RUBY and EdiTHAL clinical updates later this year.”

“I am encouraged by the results from the RUBY trial, which indicate this investigational gene editing treatment has been well-tolerated and efficacious in treated trial participants thus far. While we need to let the trial finish and enroll many other patients to understand the overall benefits and risks of this treatment, I am pleased to see transformative results at this stage in the study,” said Rabi Hanna, M.D., Department of Pediatric Hematology Oncology and Blood and Marrow Transplantation, Cleveland Clinic Children’s.

EDIT-301 uses AsCas12a, a novel, proprietary, highly efficient, and specific gene editing nuclease, to edit the promoter regions of gamma globin gene 1 and 2 to increase the expression of HbF to mimic the naturally occurring mechanism of hereditary persistence of fetal hemoglobin to treat SCD. The RUBY trial marks the first time AsCas12a was used to successfully edit human cells in a clinical trial.

EHA Oral Presentation Details:

Title: EDIT-301 Shows Promising Preliminary Safety and Efficacy Results in the Phase I/II Clinical Trial (RUBY) of Patients with Severe Sickle Cell Disease Using Highly Specific and Efficient AsCas12a Enzyme
Presenting Author: Rabi Hanna, M.D., Department of Pediatric Hematology Oncology and Blood and Marrow Transplantation, Cleveland Clinic Children’s, Cleveland, OH, United States
Date/Time: Saturday, June 10, 2023, 4:30 – 5:45 p.m. CEST/ 10:30 – 11:45 a.m. EDT
Location: Harmonie 1, Messe Frankfurt
Session: s437 Gene therapy and cellular immunotherapy – Clinical

Virtual Event Information

Editas Medicine will host a virtual event on Monday, June 12, at 8:00 a.m. ET to present the data for the RUBY and EdiTHAL trials. The live and archived webcast of the presentation will be accessible through this webcast link, or through the Events & Presentations page of the “Investors” section of the Company’s website.

EDIT-301 is currently being investigated in clinical studies in patients with severe sickle cell disease (RUBY trial, NCT04853576) and transfusion-dependent beta thalassemia (EDITHAL trial, NCT05444894). In addition to the clinical data update from the RUBY trial at EHA and in a Company-sponsored webinar, the Company expects to present a further clinical update from the RUBY and EdiTHAL trials by year-end.

About Sickle Cell Disease

Sickle cell disease is an inherited blood disorder caused by a mutation in the beta-globin gene that leads to polymerization of the sickle hemoglobin protein (HbS). In sickle cell disease, the red blood cells are misshapen in a sickle shape instead of a typical disc shape. The abnormal shape causes the red blood cells (RBCs) to have shortened lifespan and to block blood flow causing anemia, pain crises, organ failure, and early death. There are an estimated 100,000 people in the United States currently living with sickle cell disease. Higher levels of fetal hemoglobin (HbF) inhibit HbS polymerization, thus reducing the clinical manifestation of RBCs sickling.

About Beta Thalassemia

Beta thalassemia is an inherited blood disorder caused by mutations that reduce or abrogate beta globin gene expression. Insufficient beta globin production leads to ineffective red blood cell production, chronic hemolytic anemia, compensatory extramedullary hematopoiesis (creation of blood cells outside of the bone marrow), and requirement for regular blood transfusion support in patients with transfusion-dependent beta thalassemia (TDT). TDT is the most severe form of beta thalassemia, and chronic red blood cell transfusions are complicated by iron overload leading to organ dysfunction and failure. It is estimated that there are approximately 1,000 people in the United States currently living with transfusion-dependent beta thalassemia. Higher levels of fetal hemoglobin (HbF) ameliorate anemia thereby reducing the need for regular red blood cell transfusions.

About EDIT-301

EDIT-301 is an experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). EDIT-301 consists of patient-derived CD34⁺ hematopoietic stem and progenitor cells edited at the gamma globin gene (HBG1 and HBG2) promoters, where naturally occurring fetal hemoglobin (HbF) inducing mutations reside, by a highly specific and efficient proprietary engineered AsCas12a nuclease. Red blood cells derived from EDIT-301 CD34⁺ cells demonstrate a sustained increase in fetal hemoglobin production, which has the potential to provide a one-time, durable treatment benefit for people living with severe SCD and TDT.

About RUBY

The RUBY trial is a single-arm, open-label, multi-center Phase 1/2 study designed to assess the safety and efficacy of a single administration of EDIT-301 in patients with severe sickle cell disease. Additional details are available on www.clinicaltrials.gov (NCT# 04853576).

About EDITHAL

The EDITHAL trial is a single-arm, open label, multi-center Phase 1/2 study designed to assess the safety and efficacy of a single administration of EDIT-301 in patients with transfusion-dependent beta thalassemia. Additional details are available on www.clinicaltrials.gov (NCT# 05444894).

About
Editas Medicine

As a clinical-stage genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas12a and Cas9 genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute’s Cas12a patent estate and Broad Institute and Harvard University’s Cas9 patent estates for human medicines. For the latest information and scientific presentations, please visit www.editasmedicine.com.

Forward-Looking Statements

This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s plans to continue development of EDIT-301 and share further clinical updates in 2023, and its belief about EDIT-301’s potential for clinical differentiation. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials, including the RUBY trial, and clinical development of the Company’s product candidates, including EDIT-301; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.

Media and Investor Contact: Cristi Barnett (617) 401-0113 [email protected] [email protected]

Posted on June 9, 2023 3:03 am
ImmunoGen Presents Updated Findings from CADENZA Trial of Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm at EHA 2023 Congress

ImmunoGen Presents Updated Findings from CADENZA Trial of Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm at EHA 2023 Congress

Interim Analysis from Phase 2 Trial Demonstrates Compelling Anti-Tumor Activity in Patients with Frontline and Relapsed/Refractory BPDCN; No New Safety Signals Identified

Enrollment Continues in Frontline CADENZA Cohort; Top-Line Pivotal Data Expected in 2024

WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced updated data from an interim analysis of the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN). The data will be presented in an oral session on Sunday, June 11 at the European Hematology Association (EHA) 2023 Congress in Frankfurt, Germany.

The CADENZA trial is enrolling frontline BPDCN patients, including those with de novo disease and those with a prior or concomitant hematologic malignancy (PCHM). As announced in August 2022, ImmunoGen aligned with the US Food and Drug Administration (FDA) that the efficacy analysis will be conducted in de novo BPDCN patients with CR/CRc as the primary endpoint. The secondary endpoint is duration of CR/CRc. With enrollment in the R/R cohort complete, ImmunoGen expects to complete enrollment in the pivotal frontline de novo cohort this year and report top-line data in 2024.

“BPDCN is a rare and aggressive blood cancer characterized by extremely low survival rates and limited treatment options that are often associated with significant toxicities,” said Naveen Pemmaraju, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center and co-investigator of the Phase 2 study. “We are encouraged by these updated data in a larger population of patients, which demonstrated impressive anti-tumor activity and durable responses in both frontline and R/R patients. These efficacy data, coupled with outpatient administration, reinforce the potential of pivekimab as a promising, novel option for this challenging disease. I look forward to its continued evaluation in the trial.”

INTERIM ANALYSIS OF A REGISTRATION-ENABLING STUDY OF PIVEKIMAB SUNIRINE, A CD123-TARGETING ANTIBODY-DRUG CONJUGATE, IN PATIENTS WITH BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM

Lead Author: Naveen Pemmaraju, MD

Presentation ID: S139

Session Date: Sunday, June 11

Session Time: 11:30am-12:45pm CEST / 5:30am-6:45am EDT

Pivekimab is administered at 0.045 mg/kg on day 1 of a 21-day cycle as an outpatient infusion of approximately 30 minutes. As of the May 19, 2023 data cutoff, data were available for 79 BPDCN patients (30 frontline, 49 R/R). Key interim and updated safety and efficacy findings include:

Efficacy

In frontline-treated patients including those with de novo and PCHM, the objective response rate (ORR [CR, CRc, CRh, CRi, PR]) is 80% (24/30 patients) with a composite complete remission (CCR [CR, CRc, CRh, CRi]) rate of 73% (22/30 patients), and an additional patient achieving a CR post-transplant.

Median duration of response (DOR) for all responders in frontline-treated patients was 12.7 months.

In R/R patients, the ORR was 33% (16/49 patients), with a CCR rate of 20% (10/49 patients), including those who previously failed intensive chemotherapy and/or transplant.

Median DOR for all responders in R/R patients was 7.1 months.

Safety

Pivekimab continues to exhibit manageable safety; no new safety signals were observed.

The most common treatment-emergent adverse events (TEAEs) (all grades [grade 3+ events]) occurring in 15% or more of patients were peripheral edema (46% [10%]), thrombocytopenia (27% [19%]), fatigue (25% [4%]),infusion-related reactions (25% [4%]), constipation (23% [0%]), nausea (22% [0%]) anemia (20% [8%]), headache (19% [4%]), neutropenia (18% [17%]), diarrhea (17% [0%]), hypokalemia (17% [3%]), dyspnea (15% [1%]), hyperglycemia (15% [6%]) and pyrexia (15% [1%]).

No capillary leak syndrome or cytokine release syndrome are reported.

Discontinuations due to pivekimab-related adverse events are 3%.

30-day mortality is 0% in frontline-treated patients and 4% (2 deaths due to disease progression) in R/R patients.

“We look forward to completing enrollment in CADENZA this year and are pleased with the interim data in frontline BPDCN, particularly the 73% CCR rate observed in this population, as well as the responses seen in those patients with more advanced R/R disease,” said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. “With promising anti-tumor activity, manageable safety including no observed capillary leak or cytokine release syndrome, and the convenience of potential outpatient administration, we believe pivekimab could serve as a critical option for BPDCN patients.”

Additional information can be found at www.ehaweb.org.

ABOUT PIVEKIMAB SUNIRINE

Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies. Pivekimab is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza^® (azacitidine) and Venclexta^® (venetoclax) for patients with untreated and relapsed/refractory AML. Pivekimab uses one of ImmunoGen’s novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause single strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. The European Medicines Agency (EMA) granted orphan drug designation to pivekimab for the treatment of BPDCN in June 2020. Pivekimab also holds this designation in the US. In October 2020, the FDA granted pivekimab Breakthrough Therapy designation in relapsed/refractory BPDCN.

ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN)

BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the approval of a CD123-targeting therapy, the unmet need remains high for patients, both in the frontline and in the relapsed/refractory setting.

ABOUT IMMUNOGEN

ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™.

Learn more about who we are, what we do, and how we do it at www.immunogen.com.

Vidaza^®, Venclexta^® and Elzonris^® are registered trademarks of their respective owners.

FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. These statements include, but are not limited to, the potential clinical benefits of pivekimab in BPDCN and AML and the potential for regulatory approval of pivekimab. Various factors could cause ImmunoGen’s actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of the Company’s preclinical and clinical development processes; top-line data may change as more patient data become available and are subject to audit and verification procedures; the timing and outcome of the Company’s preclinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of preclinical studies, clinical trials, and regulatory processes; the timing and outcome of the Company’s anticipated interactions with regulatory authorities; the risk that the Company may not be able to obtain adequate price and reimbursement for any approved products, including the potential for delays or additional difficulties for ELAHERE in light of the FDA granting accelerated approval; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and the resulting impact on ImmunoGen’s industry and business; and other factors as set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2023, the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commision on April 28, 2023, and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. ImmunoGen undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230609005049/en/

INVESTOR RELATIONS

ImmunoGen

Anabel Chan

781-895-0600

[email protected]

MEDIA

ImmunoGen

Courtney O’Konek

781-895-0600

[email protected]

OR

FTI Consulting

Robert Stanislaro

212-850-5657

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health General Health Research Pharmaceutical Science Biotechnology

MEDIA:

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Posted on June 9, 2023 2:57 am
Prime Number Capital LLC Initiates Coverage on XIAO-I Corporation (NASDAQ:AIXI)

NEW YORK, June 09, 2023 (GLOBE NEWSWIRE) — Prime Number Capital LLC initiated coverage of XIAO-I Corporation (NASDAQ: AIXI). The research report by the analyst at Prime Number Capital LLC based on the target price and current market conditions.

XIAO-I Corporation, a leading cognitive intelligence enterprise in China, offers a diverse range of business solutions and services in artificial intelligence, including natural language processing, voice and image recognition, machine learning, and affective computing. The company has demonstrated its expertise in the field and has a track record of providing reliable and effective AI solutions to various industries.

The projected annual revenue for XIAO-I Corporation is estimated to reach 133.59 million USD in 2024, with a projected net income of 16.97 million USD in the same year.

Several key factors contribute to the positive outlook on XIAO-I Corporation:

First-mover advantage in AI: Being an early entrant in the market has positioned XIAO-I as a leader and established significant market share. The company has a strong research team, with nearly 300 experts and a substantial number of patents, providing a competitive edge that is difficult for competitors to replicate.

In-house LLM deployment: XIAO-I’s upcoming release of its self-developed Large Language Model (LLM) in June is a noteworthy development. This LLM aims to enhance the capabilities of its narrow AI systems, enabling them to handle more complex problems with better precision. This innovation is expected to bolster XIAO-I’s competitive advantage.

Increasing adoption of AI technology: The surge in the adoption of AI technology across industries, driven by advancements in Natural Language Processing (NLP), presents significant opportunities for XIAO-I. The company’s expertise in leveraging AI and NLP to address industry-specific challenges positions it to expand its customer base and explore new revenue streams.

Diverse customer base: XIAO-I serves customers across various industries, including Contact Center, Finance, Urban Public Service, Construction, Metaverse, Manufacturing, and Smart Healthcare. By implementing advanced NLP solutions tailored to specific industries, XIAO-I has the potential to capture untapped market segments and generate additional growth.

Mandarin NLP specialization and regulatory environment: XIAO-I’s specialization in Mandarin NLP gives it a competitive advantage in serving Mandarin-speaking users. Furthermore, the strict regulatory environment for foreign tech companies operating in China creates barriers to entry for competitors, providing XIAO-I with a favorable market position.

Vertical expansions for better monetization: By collaborating with industries vertically, XIAO-I gains comprehensive knowledge and insights into each industry’s pain points. This allows the company to develop more effective solutions and capitalize on better monetization opportunities.

The favorable AI market conditions in China further enhance XIAO-I’s growth prospects. According to Frost & Sullivan, China’s AI market has experienced exponential growth, reaching USD 388 billion in 2021, with a compound annual growth rate of 47.9%. The Chinese government’s supportive policies, strong R&D capabilities, extensive data volume, and relatively low cost of technology personnel have contributed to this growth. The projected penetration rate of the AI market in China is expected to reach 32.7% by 2026, with a market size of USD 219.1 billion.

As XIAO-I Corporation continues its journey as a B2B-focused AI powerhouse, Prime Number Capital believes that the company’s domain-oriented strategy and cognitive intelligence technologies will drive sustainable and profitable growth in the long term. With the upcoming release of its LLM, XIAO-I is poised to offer innovative solutions and expand its market share across industries and domains.

For more information about XIAO-I Corporation, please visit https://www.xiaoi.com.

Disclosures

Please refer to the initiation report for full disclosures. Prime Number Capital LLC has managed a public offering of securities for the subject company Xiao-I Corporation in the past 12 months. Prime Number Capital LLC has received compensation for investment banking services from the subject company Xiao-I Corporation in the past 12 months. The subject company Xiao-I Corporation currently is or during the 12-month period preceding the date of distribution of this research was a client of Prime Number Capital LLC and received investment banking services. Prime Number Capital LLC may continue to receive, or intends to seek, compensation for investment banking services in the next 12 months from Xiao-I corporation. The research analyst and research associate have not received compensation based upon various factors, including quality of research, investor client feedback, and Prime Number Capital LLC ‘s overall revenues, which includes investment banking revenues for Xiao-I Corporation. Prime Number Capital LLC, at the time of publication, does not make a market in the subject company Xiao-I Corporation.

For further questions, please contact:

Prime Number Capital LLC
Mr. Hao Sheng
Email: [email protected]
Phone: 516-582-9666

Posted on June 9, 2023 2:05 am
Stellantis and Archer Host European Debut of Midnight eVTOL Aircraft at 2023 Paris Air Show

Stellantis and Archer Host European Debut of Midnight
eVTOL
Aircraft
a
t
2023
Paris Air Show

AMSTERDAM and SANTA CLARA, CALIFORNIA, June
9
, 2023 – Archer Aviation Inc. (NYSE: ACHR) and Stellantis N.V. will attend the 54^th edition of the 2023 Paris Air Show, starting June 19, 2023, to share progress toward scaling manufacturing of Archer’s Midnight eVTOL aircraft as Archer prepares for planned commercialization in 2025.

Archer’s Midnight aircraft will be the featured eVTOL aircraft at the Paris Air Show, positioned in the center of the Air Mobility event, which is located in Hall 5 at Le Bourget Airport. Dedicated to the latest innovations and emerging technologies in eVTOL, the Paris Air Show’s Air Mobility event will bring together key players of this sector with three days of discussions focused on the maturation of advanced air mobility and its impact on the future of aerospace.

This unique partnership in the eVTOL aircraft industry between Archer and Stellantis will leverage each company’s respective strengths and competencies to bring the Midnight aircraft to market at scale. To complement Archer’s world-class team of eVTOL aircraft, electric powertrain and certification experts, Stellantis is contributing advanced manufacturing technology and expertise, experienced personnel and capital to the partnership. This combination is intended to enable the rapid scaling of aircraft production to meet Archer’s commercialization plans, while allowing Archer to strengthen its path to commercialization by helping it avoid hundreds of millions of dollars of spending during the manufacturing ramp up phase.

# # #

About Archer

Archer is designing and developing electric vertical takeoff and landing aircraft for use in urban air mobility networks. Archer’s mission is to unlock the skies, freeing everyone to reimagine how they move and spend time. Archer’s team is based in Santa Clara, CA.

To learn more, visit www.archer.com.

About Stellantis

Stellantis N.V. (NYSE: STLA / Euronext Milan: STLAM / Euronext Paris: STLAP) is one of the world’s leading automakers and a mobility provider. Its storied and iconic brands embody the passion of their visionary founders and today’s customers in their innovative products and services, including Abarth, Alfa Romeo, Chrysler, Citroën, Dodge, DS Automobiles, Fiat, Jeep®, Lancia, Maserati, Opel, Peugeot, Ram, Vauxhall, Free2move and Leasys. Powered by our diversity, we lead the way the world moves – aspiring to become the greatest sustainable mobility tech company, not the biggest, while creating added value for all stakeholders as well as the communities in which it operates.

For more information, visit www.stellantis.com.

Archer Media Contacts:

The Brand Amp – [email protected]

Stellantis Media Contacts

Fernão SILVEIRA +31 6 43 25 43 41 – [email protected]
Valerie GILLOT +33 6 83 92 92 96 – [email protected]

Archer Forward Looking Statements

This press release contains forward looking statements regarding Archer’s future business plans and product roadmaps, including statements regarding the timing of Archer’s development, commercialization, and certification of its eVTOL aircraft. These forward looking statements are only predictions and may differ materially from actual results due to a variety of factors. The risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed in Archer’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, available at www.sec.gov. In addition, please note that any forward looking statements contained herein are based on assumptions that Archer believes to be reasonable as of the date of this press release. Archer undertakes no obligation to update these statements as a result of new information or future events.

Stellantis
Forward Looking Statements

This communication contains forward-looking statements. In particular, statements regarding future events and anticipated results of operations, business strategies, the anticipated benefits of the proposed transaction, future financial and operating results, the anticipated closing date for the proposed transaction and other anticipated aspects of our operations or operating results are forward-looking statements. These statements may include terms such as “may”, “will”, “expect”, “could”, “should”, “intend”, “estimate”, “anticipate”, “believe”, “remain”, “on track”, “design”, “target”, “objective”, “goal”, “forecast”, “projection”, “outlook”, “prospects”, “plan”, or similar terms. Forward-looking statements are not guarantees of future performance. Rather, they are based on Stellantis’ current state of knowledge, future expectations and projections about future events and are by their nature, subject to inherent risks and uncertainties. They relate to events and depend on circumstances that may or may not occur or exist in the future and, as such, undue reliance should not be placed on them.
Actual results may differ materially from those expressed in forward-looking statements as a result of a variety of factors, including: the impact of the COVID-19 pandemic, the ability of Stellantis to launch new products successfully and to maintain vehicle shipment volumes; changes in the global financial markets, general economic environment and changes in demand for automotive products, which is subject to cyclicality; changes in local economic and political conditions, changes in trade policy and the imposition of global and regional tariffs or tariffs targeted to the automotive industry, the enactment of tax reforms or other changes in tax laws and regulations; Stellantis’ ability to expand certain of their brands globally; its ability to offer innovative, attractive products; its ability to develop, manufacture and sell vehicles with advanced features including enhanced electrification, connectivity and autonomous-driving characteristics; various types of claims, lawsuits, governmental investigations and other contingencies, including product liability and warranty claims and environmental claims, investigations and lawsuits; material operating expenditures in relation to compliance with environmental, health and safety regulations; the intense level of competition in the automotive industry, which may increase due to consolidation; exposure to shortfalls in the funding of Stellantis’ defined benefit pension plans; the ability to provide or arrange for access to adequate financing for dealers and retail customers and associated risks related to the establishment and operations of financial services companies; the ability to access funding to execute Stellantis’ business plans and improve its businesses, financial condition and results of operations; a significant malfunction, disruption or security breach compromising information technology systems or the electronic control systems contained in Stellantis’ vehicles; Stellantis’ ability to realize anticipated benefits from joint venture arrangements; disruptions arising from political, social and economic instability; risks associated with our relationships with employees, dealers and suppliers; increases in costs, disruptions of supply or shortages of raw materials, parts, components and systems used in Stellantis’ vehicles; developments in labor and industrial relations and developments in applicable labor laws; exchange rate fluctuations, interest rate changes, credit risk and other market risks; political and civil unrest; earthquakes or other disasters; risks and other items described in the Company’s Annual Report on Form 20-F for he year ended December 31, 2022 and Current Reports on Form 6-K and amendments thereto filed with the SEC; and other risks and uncertainties.

Any forward-looking statements contained in this communication speak only as of the date of this document and Stellantis disclaims any obligation to update or revise publicly forward-looking statements. Further information concerning Stellantis and its businesses, including factors that could materially affect Stellantis’ financial results, is included in Stellantis’ reports and filings with the U.S. Securities and Exchange Commission and AFM.

Attachment

EN-20230609-Archer-Stellantis-Paris-Air-Show-Media-Advisory

Posted on June 9, 2023 2:03 am
Stellantis and Archer Host European Debut of Midnight eVTOL Aircraft at 2023 Paris Air Show

Stellantis and Archer Host European Debut of Midnight eVTOL Aircraft at 2023 Paris Air Show

AMSTERDAM & SANTA CLARA, Calif.–(BUSINESS WIRE)–Archer Aviation Inc. (NYSE: ACHR) and Stellantis N.V. will attend the 54^th edition of the 2023 Paris Air Show, starting June 19, 2023, to share progress toward scaling manufacturing of Archer’s Midnight eVTOL aircraft as Archer prepares for planned commercialization in 2025.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005829/en/

Archer’s Midnight eVTOL aircraft. (Photo: Business Wire)

Archer’s Midnight aircraft will be the featured eVTOL aircraft at the Paris Air Show, positioned in the center of the Air Mobility event, which is located in Hall 5 at Le Bourget Airport. Dedicated to the latest innovations and emerging technologies in eVTOL, the Paris Air Show’s Air Mobility event will bring together key players of this sector with three days of discussions focused on the maturation of advanced air mobility and its impact on the future of aerospace.

This unique partnership in the eVTOL aircraft industry between Archer and Stellantis will leverage each company’s respective strengths and competencies to bring the Midnight aircraft to market at scale. To complement Archer’s world-class team of eVTOL aircraft, electric powertrain and certification experts, Stellantis is contributing advanced manufacturing technology and expertise, experienced personnel and capital to the partnership. This combination is intended to enable the rapid scaling of aircraft production to meet Archer’s commercialization plans, while allowing Archer to strengthen its path to commercialization by helping it avoid hundreds of millions of dollars of spending during the manufacturing ramp up phase.

About Archer

Archer is designing and developing electric vertical takeoff and landing aircraft for use in urban air mobility networks. Archer’s mission is to unlock the skies, freeing everyone to reimagine how they move and spend time. Archer’s team is based in Santa Clara, CA.

To learn more, visit www.archer.com.

About Stellantis

Stellantis N.V. (NYSE: STLA / Euronext Milan: STLAM / Euronext Paris: STLAP) is one of the world’s leading automakers and a mobility provider. Its storied and iconic brands embody the passion of their visionary founders and today’s customers in their innovative products and services, including Abarth, Alfa Romeo, Chrysler, Citroën, Dodge, DS Automobiles, Fiat, Jeep®, Lancia, Maserati, Opel, Peugeot, Ram, Vauxhall, Free2move and Leasys. Powered by our diversity, we lead the way the world moves – aspiring to become the greatest sustainable mobility tech company, not the biggest, while creating added value for all stakeholders as well as the communities in which it operates.

For more information, visit www.stellantis.com.

Archer Forward Looking Statements

This press release contains forward looking statements regarding Archer’s future business plans and product roadmaps, including statements regarding the timing of Archer’s development, commercialization, and certification of its eVTOL aircraft. These forward looking statements are only predictions and may differ materially from actual results due to a variety of factors. The risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed in Archer’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, available at www.sec.gov. In addition, please note that any forward looking statements contained herein are based on assumptions that Archer believes to be reasonable as of the date of this press release. Archer undertakes no obligation to update these statements as a result of new information or future events.

Stellantis Forward Looking Statements

This communication contains forward-looking statements. In particular, statements regarding future events and anticipated results of operations, business strategies, the anticipated benefits of the proposed transaction, future financial and operating results, the anticipated closing date for the proposed transaction and other anticipated aspects of our operations or operating results are forward-looking statements. These statements may include terms such as “may”, “will”, “expect”, “could”, “should”, “intend”, “estimate”, “anticipate”, “believe”, “remain”, “on track”, “design”, “target”, “objective”, “goal”, “forecast”, “projection”, “outlook”, “prospects”, “plan”, or similar terms. Forward-looking statements are not guarantees of future performance. Rather, they are based on Stellantis’ current state of knowledge, future expectations and projections about future events and are by their nature, subject to inherent risks and uncertainties. They relate to events and depend on circumstances that may or may not occur or exist in the future and, as such, undue reliance should not be placed on them.

Actual results may differ materially from those expressed in forward-looking statements as a result of a variety of factors, including: the impact of the COVID-19 pandemic, the ability of Stellantis to launch new products successfully and to maintain vehicle shipment volumes; changes in the global financial markets, general economic environment and changes in demand for automotive products, which is subject to cyclicality; changes in local economic and political conditions, changes in trade policy and the imposition of global and regional tariffs or tariffs targeted to the automotive industry, the enactment of tax reforms or other changes in tax laws and regulations; Stellantis’ ability to expand certain of their brands globally; its ability to offer innovative, attractive products; its ability to develop, manufacture and sell vehicles with advanced features including enhanced electrification, connectivity and autonomous-driving characteristics; various types of claims, lawsuits, governmental investigations and other contingencies, including product liability and warranty claims and environmental claims, investigations and lawsuits; material operating expenditures in relation to compliance with environmental, health and safety regulations; the intense level of competition in the automotive industry, which may increase due to consolidation; exposure to shortfalls in the funding of Stellantis’ defined benefit pension plans; the ability to provide or arrange for access to adequate financing for dealers and retail customers and associated risks related to the establishment and operations of financial services companies; the ability to access funding to execute Stellantis’ business plans and improve its businesses, financial condition and results of operations; a significant malfunction, disruption or security breach compromising information technology systems or the electronic control systems contained in Stellantis’ vehicles; Stellantis’ ability to realize anticipated benefits from joint venture arrangements; disruptions arising from political, social and economic instability; risks associated with our relationships with employees, dealers and suppliers; increases in costs, disruptions of supply or shortages of raw materials, parts, components and systems used in Stellantis’ vehicles; developments in labor and industrial relations and developments in applicable labor laws; exchange rate fluctuations, interest rate changes, credit risk and other market risks; political and civil unrest; earthquakes or other disasters; risks and other items described in the Company’s Annual Report on Form 20-F for he year ended December 31, 2022 and Current Reports on Form 6-K and amendments thereto filed with the SEC; and other risks and uncertainties.

Any forward-looking statements contained in this communication speak only as of the date of this document and Stellantis disclaims any obligation to update or revise publicly forward-looking statements. Further information concerning Stellantis and its businesses, including factors that could materially affect Stellantis’ financial results, is included in Stellantis’ reports and filings with the U.S. Securities and Exchange Commission and AFM.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230608005829/en/

Archer Media Contacts:

The Brand Amp –[email protected]

Stellantis Media Contacts

Fernão Silveira +31 6 43 25 43 41 – [email protected]

Valerie Gillot +33 6 83 92 92 96 –[email protected]

KEYWORDS: California Europe United States Netherlands North America

INDUSTRY KEYWORDS: Air Transport Aerospace Manufacturing

MEDIA:

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Archer’s Midnight eVTOL aircraft. (Photo: Business Wire)

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