Market Newsdesk

ROCHESTER, N.Y., June 08, 2021 (GLOBE NEWSWIRE) — Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology Company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced that the first clinical sites have been activated to screen and enroll patients in its Phase 1/2 study evaluating pepinemab as a single agent in Alzheimer’s disease (AD) and in its phase 2 study in of pepinemab combination with Merck’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) as front-line treatment for advanced, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The Company plans to activate at least 13 U.S. sites for the Alzheimer study and 18 U.S. sites for HNSCC.

The Alzheimer’s proof-of-concept study is expected to enroll at least 40 patients with key efficacy endpoints that include measures of cognition and brain imaging. This study has received funding support from the Alzheimer’s Drug Discovery Foundation and the Alzheimer’s Association. The HNSCC study will enroll up to 65 patients allocated to different levels of combined positive score (The HNSCC study is expected to enroll up to 65 patients allocated to different levels of combined positive score (CPS) of PD-L1 expression. CPS is a biomarker associated with benefit in response to immunotherapy. Efficacy endpoints will focus on objective response rate (ORR) per RECIST 1.1 criteria, as well as progression-free survival (PFS), overall survival (OS) and duration of response (DOR).

Dr. Maurice Zauderer, chief executive officer of Vaccinex, stated, “With this Alzheimer’s study, we are building on prior data from our SIGNAL phase 2 study in Huntington’s disease that we believe indicated cognitive benefit to patients at an early stage of this devastating neurodegenerative disease. It was particularly encouraging that this was accompanied by evidence of increased brain metabolic activity which has been shown in several independent studies to correlate with cognitive change in AD as well. AD patients are in urgent need of new therapies to effectively slow or halt disease progression, and we are looking forward to results from this important study.  

“In addition, we recently published results of a prior phase 2 study of pepinemab in combination with a checkpoint inhibitor, EMD Serono’s Bavencio^®, that we believe indicated treatment benefit to patients with non-small cell lung cancer. We are pleased to have now initiated this new trial in HNSCC in collaboration with Merck, a global immunotherapy leader. We and others have shown that SEMA4D is highly expressed in head and neck cancer and triggers increased levels of myeloid-derived suppressor cells that inhibit immune responses to tumor, providing a compelling scientific rationale for this study,” Dr. Zauderer concluded.    

Multiple prior preclinical studies suggested that inhibition of SEMA4D has unique mechanisms of action that reduce activation of inflammatory glial cells in brain but increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in a tumor microenvironment. The Company is pleased and excited to have the opportunity to develop this potentially promising therapy in multiple important indications.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Bavencio^® is a registered trademark of EMD Serono, Inc., the U.S. biopharmaceutical business of Merck KGaA, Darmstadt, Germany.

Forward Looking Statements

To the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about the Company’s plans, expectations and objectives with respect to the results and timing of clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington’s and Alzheimer’s disease and other indications, and other statements identified by words such as “may,” “will,” “appears,” “expect,” “planned,” “anticipate,” “estimate,” “intend,” “hypothesis,” “potential,” “advance,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of the Company’s research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to the Company’s dependence on its lead product candidate pepinemab, the ability to leverage its ActivMAb^® platform, the impact of the COVID-19 pandemic, and other matters that could affect its development plans or the commercial potential of its product candidates. Except as required by law, the Company assumes no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in the Company’s periodic reports filed with the Securities and Exchange Commission (“SEC”) and the other risks and uncertainties described in the Company’s Form 10-K for year end December 31, 2021 and subsequent filings with the SEC.

Investor Contact                                
Jeremy Feffer                                        
LifeSci Advisors, LLC                                
212-915-2568                                        
[email protected]                        

WIXOM, Mich. and ANKARA, Turkey, June 08, 2021 (GLOBE NEWSWIRE) — Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, and Drogsan Pharmaceuticals, a leading pharmaceutical company in Turkey with an established presence in the nephrology space having launched the first locally manufactured biosimilar in 2014 and building it to be the leader in the Epoetin Alfa market in Turkey, today announced that the Companies entered into an exclusive license agreement for the rights to commercialize Triferic AVNU (ferric pyrophosphate citrate injection) in Turkey.

Under the terms of the license agreement, Drogsan will be the exclusive development and commercialization partner for Triferic in Turkey and Rockwell Medical will supply the product to Drogsan. The agreement also allows for Drogsan to negotiate further geographic expansion into the surrounding region. In consideration for the license, Rockwell Medical will receive an upfront fee and will be eligible for milestone payments based on reimbursement price approval.

“As we continue to drive opportunities to bring Triferic to patients around the world, this agreement represents important progress to address the needs of iron deficient patients in Turkey,” said Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical. “Drogsan is our partner of choice, with 45 years of pharmaceutical experience and a robust infrastructure, deep relationships and substantial coverage of nephrologists, key opinion leaders and dialysis centers across Turkey. Their highly experienced nephrology commercial team has a strong track record of successful new product launches. We look forward to working closely with Drogsan to bring Triferic to patients in need.”

“We welcome this opportunity to collaborate with Rockwell Medical and bring Triferic to hemodialysis patients in Turkey,” said Mustafa Karpuzcu, Chairman and Chief Executive Officer of Drogsan Pharmaceuticals. “With approximately 65,000 patients receiving hemodialysis every year in Turkey and the number of these patients expected to continue to increase, we believe this partnership is vital to bridging the unmet need for innovative medicine to address iron deficiency in these patients.”

About Rockwell Medical

Rockwell Medical is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead to transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients’ lives. The Company has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. Rockwell Medical is also advancing its FPC platform by developing FPC for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting. In addition, Rockwell Medical is one of two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States. For more information, visit www.RockwellMed.com.

About
Drogsan Pharmaceuticals

Established in 1975 as a member of Nevzat Group – active in the health sector for 59 years with 1,400 employees and $400 million turnover in total, Drogsan has become a leading pharmaceutical company in Turkey. Drogsan brings an established presence in the nephrology space having launched the first locally manufactured biosimilar in 2014 and building it to be the leader in the Epoetin Alfa market in Turkey. Drogsan with its long-standing experience has a strong commercial team active in selected therapeutic fields in Turkey, as well as a wide network of distribution in several countries in Eastern & Southern Europe, CIS, Middle East, Africa, Central & Southeast Asia.

About Triferic Dialysate and Triferic AVNU

Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment. Triferic Dialysate and Triferic AVNU have a unique and differentiated mechanism of action, which has the potential to benefit patients and health care economics. Triferic Dialysate and Triferic AVNU represent a potential innovative medical advancement in hemodialysis patient iron management – with the potential to become the future standard of care.

Triferic Dialysate and Triferic AVNU both deliver approximately 5-7 mg iron with every hemodialysis treatment to replace the ongoing losses to maintain hemoglobin without increasing iron stores. Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body), which is then transported to the bone marrow to be incorporated into hemoglobin. Because of this unique mechanism of action, there is no increase in ferritin (a measure of stored iron). Triferic and Triferic AVNU address a significant medical need in treating Functional Iron Deficiency in end-stage kidney disease patients. The safety profile of Triferic is similar to placebo in controlled clinical trials in patients with end-stage kidney disease. Since approval, there have been no safety related changes to the product labeling.

IMPORTANT SAFETY INFORMATION FOR TRIFERIC AND TRIFERIC AVNU

INDICATION

TRIFERIC and TRIFERIC AVNU are indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Limitations of Use

TRIFERIC and TRIFERIC AVNU are not intended for use in patients receiving peritoneal dialysis. TRIFERIC and TRIFERIC AVNU have not been studied in patients receiving home hemodialysis.

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving TRIFERIC in two randomized clinical trials.

Iron status should be determined on pre-dialysis blood samples. Post-dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

Adverse Reactions

Most common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

To report an Adverse Events (AE) or Product Quality Control (PQC) please call the Medical Information Department at (855) 333-4315 or e-mail at [email protected].

For full Safety and Prescribing Information please visit www.Triferic.com and www.Trifericavnu.com.

Rockwell Medical Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, the receipt milestone payments and royalties by Rockwell Medical, the timing of product sales in Turkey, the receipt of regulatory approvals in Turkey and the potential market opportunity for Triferic in Turkey. Words such as, “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “can,” “would,” “develop,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical’s SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic (including, applicable federal, state or local orders) on business and operating results; receipt of regulatory approval for Triferic in Turkey; Drogsan’s ability to successfully launch Triferic which will impact Rockwell’s ability to achieve milestones and receive royalty payments; the ability to manufacture the product in accordance with Turkey’s regulations, international relations between the United States and Turkey, currency fluctuation of the Turkish Lira, anticipated market opportunity in Turkey; and those risks more fully discussed in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the period ended March 31, 2021 and of our Annual Report on Form 10-K for the year ended December 31, 2020, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

Triferic® is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

ROCKWELL MEDICAL CONTACTS

Investors:

Argot Partners
212.600.1902
[email protected]

Media:

David Rosen
Argot Partners
212.600.1902
[email protected]

CAMBRIDGE, Mass., June 08, 2021 (GLOBE NEWSWIRE) — Foghorn Therapeutics Inc. (Nasdaq: FHTX), a company pioneering the discovery and development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, today announced that it will host a research and development webinar on June 15th from 9:00 AM – 11:00 AM EDT.

The event will feature presentations from the Foghorn Therapeutics management team, as well as Key Opinion Leaders Howard A. “Skip” Burris III, M.D., F.A.S.C.O., F.A.C.P., of the Sarah Cannon Research Institute, and Eytan Stein, M.D., of the Memorial Sloan Kettering Cancer Center. In addition, scientific cofounder Cigall Kadoch will discuss the biological importance of the chromatin regulatory system (CRS) in gene expression and human disease and its broad applicability in precision oncology.

The discussion will include an overview of Foghorn’s Gene Traffic Control platform and pipeline.

A live question and answer session will follow the formal presentation. To register for the webinar, please click here.

Howard A. “Skip” Burris III, MD, FASCO, FACP

Howard A. “Skip” Burris III, MD, FASCO, FACP serves as President and Chief Medical Officer of Sarah Cannon, as well as the executive director, drug development for the Sarah Cannon Research Institute. He is an associate of Tennessee Oncology, PLLC, where he practices medical oncology.

Dr. Burris’ clinical research career has focused on the development of new cancer agents with an emphasis on first–in–human therapies, having led the trials of many novel antibodies, small molecules, and chemotherapies now FDA approved. In 1997, he established the first community–based early phase drug development program in Nashville, which grew into the Sarah Cannon Research Institute. He has authored over 400 publications and 700 abstracts.

Dr. Burris served as president of ASCO from 2019-2020 and is serving as Chairman of the Board for the 2020-2021 term. He also currently serves on the Board of ASCO’s Conquer Cancer Foundation. Additionally, in 2014, Dr. Burris was selected by his peers as a Giant of Cancer Care for his achievements in drug development.

Dr. Burris completed his undergraduate education at the United States Military Academy at West Point, his medical degree at the University of South Alabama, and his internal medicine residency and oncology fellowship at Brooke Army Medical Center in San Antonio. While in Texas, he also served as the Director of Clinical Research at The Institute for Drug Development of the Cancer Therapy and Research Center and The University of Texas Health Science Center. He attained the rank of lieutenant colonel in the US Army, and among his decorations, he was awarded a Meritorious Service Medal with oak leaf cluster for his service in Operation Joint Endeavor.

Eytan Stein, M.D.

Eytan Stein, M.D. received his medical degree from Northwestern University in Chicago, where he also completed his internal medicine residency. He then completed his fellowships in medicine at Weill Cornell Medical College, and in medical oncology and hematology at Memorial Sloan Kettering. He is an Assistant Professor on the Leukemia Service at Memorial Sloan Kettering Cancer Center in New York City.

Dr. Stein holds board certification from the American Board of Internal Medicine, American Board of Clinical Oncology, and the American Board of Hematology. He focuses his practice on the treatment of acute and chronic leukemias, myelodysplastic syndromes, and myeloproliferative neoplasms. His research interests include developing novel, early phase clinical trials of compounds that target the genetic and epigenetic basis of myeloid malignancies.

Cigall Kadoch, Ph.D.

Cigall Kadoch, Ph.D., is an academic leader and entrepreneur in the biomedical sciences field. She is an Associate Professor of Pediatric Oncology at the Dana-Farber Cancer Institute and Institute Member and Epigenomics Program Co-Director at the Broad Institute of MIT and Harvard. She is also the Scientific Founder of Foghorn Therapeutics (NASDAQ: FHTX), where she currently serves on the Board of Directors and Scientific Advisory Board.

Dr. Kadoch established her independent laboratory in 2014, at age 28, one of the youngest scientists ever appointed to the Harvard Medical School faculty, immediately following completion of her Ph.D. studies at Stanford University. She is a leading expert in chromatin and gene regulation and is internationally recognized for her groundbreaking studies in these areas. Specifically, her laboratory studies the structure and function of nuclear protein complexes that govern DNA architecture and gene expression, called chromatin remodeling complexes, perturbations in which cause a range of human cancers and neurodevelopmental disorders.

Dr. Kadoch has received numerous prestigious awards and research grants for her work, including the NIH Director’s New Innovator Award, the American Association for the Advancement of Science (AAAS) Martin and Rose Wachtel Cancer Research Prize, the American Association for Cancer Research Outstanding Achievement in Basic Cancer Research, and was recently named a finalist for the Blavatnik National Awards. Additionally, she has been named to the Forbes 30 Under 30 list, MIT Technology Review 35 Innovators Under 35, Popular Science Brilliant 10, and Business Insider Top 30 Young Leaders in Biopharma.

About FHD-286

FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, two highly similar proteins that are the ATPases, or the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors.

About AML

Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.

About Uveal Melanoma

Uveal (intraocular) melanoma is a rare eye cancer that forms from cells that make melanin in the iris, ciliary body, and choroid. It is the most common eye cancer in adults. It is diagnosed in about 2,000 adults every year in the United States and occurs most often in lightly pigmented individuals with a median age of 55 years. However, it can occur in all races and at any age. UM metastasizes in approximately 50% of cases, leading to very poor prognosis.

About Foghorn Therapeutics

Foghorn^® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control^® platform, Foghorn is systematically studying, identifying and validating potential drug targets within the chromatin regulatory system. The company is developing multiple product candidates in oncology.

Forward-Looking Statements

This press release contains “forward-looking statements” regarding the Company’s clinical programs for FHD-286. Forward-looking statements include statements regarding the Company’s clinical trial, product candidates and research efforts and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risk regarding the timing of filing an IND for our product candidates and other factors set forth under the heading “Risk Factors” in the Company’s Form 10-K. Any forward-looking statement made in this press release speaks only as of the date on which it is made.

Media Contact:

Fanny Cavalié, Foghorn Therapeutics
[email protected]

Gregory Kelley, Ogilvy
[email protected]

Investor Relations Contact:

Allan Reine, Foghorn Therapeutics
[email protected]

Hans Vitzthum, LifeSci Advisors
617-430-7578
[email protected]

 

NEW YORK, June 08, 2021 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced a late-breaking poster presentation of the company’s lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), in combination with pegfilgrastim in breast cancer as part of the Phase 3 PROTECTIVE-2 chemotherapy-induced neutropenia (CIN) study, at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting being held from June 8-11, 2021.

BeyondSpring’s poster titled “Adding Plinabulin (Plin) to Pegfilgrastim (Peg) Reverses the Immune Suppressive Potential of Peg while Offering Superior Prevention of Chemotherapy Induced Neutropenia (CIN) versus Peg Alone),” will be presented on June 9, 2021 at 3:15 p.m. PDT and authors will be available at the poster reception on June 10, 2021 from 4:45 p.m. – 5:30 p.m. PDT (Poster number TH58). Plinabulin in combination with pegfilgrastim demonstrated a superior immune profile and CIN prevention outcomes for patients treated with plinabulin in combination with pegfilgrastim compared to pegfilgrastim alone in breast cancer patients dosed with TAC (Taxotere, doxorubicin, and cyclophosphamide) in PROTECTIVE-2 Phase 3 study. Compared to pegfilgrastim alone (n=110), the plinabulin and pegfilgrastim combination (n=111) showed decreased production of immature neutrophil band (p=0.0012), and decreased promyelocytes and myelocyte production (p=0.0488). Immature neutrophil band and promyelocytes and myelocytes are less functional defending against infection and have potentially deleterious immune suppression effects.

“Plinabulin has broad effects on the immune system and tumor microenvironment. We are excited to see that in addition to the well-demonstrated CIN prevention benefits, we also see that plinabulin can protect against some of the immune-suppressive side effects of pegfilgrastim,” said Ramon Mohanlal M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring “Plinabulin is a pipeline-in-a-drug and we are seeing more evidence of this with every study, demonstrating that it can help patients with cancer, from side-effects to cancer treatment.”

The Company has submitted New Drug Applications (NDA) for plinabulin in combination with pegfilgrastim as a treatment for the prevention of CIN for review in both the U.S. and China. The U.S. FDA accepted the NDA with Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2021.

About The Federation of Clinical Immunology Societies (FOCIS) Annual Meeting

The Federation of Clinical Immunology Societies (FOCIS) exists to improve human health through immunology by fostering interdisciplinary approaches to both understand and treat immune-based diseases. The Federation of Clinical Immunology Societies is a key forum where opinion leaders come together to chart the path to the next major breakthrough in disease therapy. Through FOCIS, researchers and clinicians share knowledge across traditional disease borders, and identify commonalities between treatments and therapies that are life-changing for those impacted by immune-mediated diseases. Initially established as a cross-disciplinary meeting, FOCIS held its first Annual Meeting in 2001. After two successful consecutive meetings, FOCIS incorporated as a 501(c)3 organization in 2003. Today, FOCIS has 58 Member Societies, representing roughly 65,000 clinician scientists.

About CIN

CIN remains a severely unmet medical need and is the primary cause for the 4D’s (Decrease, Delay, Discontinue dose and Downgrade regimen) that compromise carefully selected cancer treatment regimens. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen® was approved in 1991. The main benefit of G-CSF treatment, however, is in Week 2 after chemotherapy. Week 1 after chemotherapy is considered the “neutropenia vulnerability gap” where over 75% of CIN-related clinical complications occur, including febrile neutropenia, infection, hospitalization and death. Plinabulin is the first drug seeking FDA approval that has the potential to fill this gap. Combining plinabulin and G-CSF may maximize the protection of patients for the full cycle of chemotherapy, as demonstrated in the PROTECTIVE-2 Phase 3 registration study.

Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever (also called FN). Due to the COVID-19 pandemic, the updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, including pegfilgrastim, from high-risk patients only (chemo FN rate >20%), to include intermediate-risk patients (FN rate between 10-20%), to reduce the number of hospital/ER visits related to CIN. The revision of the NCCN guidelines effectively increases the addressable market of patients to approximately 467,500 cancer patients in the U.S. annually.

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA). It is a novel, intravenous infused, patent-protected, NDA ready asset for CIN prevention indication and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received breakthrough designation from both US and China FDA for CIN prevention indication. As a “pipeline in a drug,” plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody resistant patients.

About BeyondSpring

Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset plinabulin, is being developed as a “pipeline in a drug.” It is filed for approval in the US and China for the prevention of chemotherapy-induced neutropenia (CIN) and has a fully enrolled pivotal study to test an anti-cancer benefit with an overall survival primary endpoint in NSCLC. Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies, and re-sensitize PD-1/PD-L1 antibody resistant patients. In addition to plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company if at all, unexpected results of clinical trials, delays or denial in the regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Investor Contact:

Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
[email protected]

Media Contact:

Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
[email protected]