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• Initial findings from the DEVOTE study suggest no new safety concerns and support continued development of a higher dose of SPINRAZA^® (nusinersen)
• Additional research reinforces the potential of biomarkers and highlights new digital tools that may help guide future treatment approaches and decisions for people with SMA

CAMBRIDGE, Mass., April 19, 2021 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced new data from the SPINRAZA^® (nusinersen) clinical development program aimed at optimizing outcomes for people with spinal muscular atrophy (SMA) and advancing understanding of the disease. These data are being presented at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting, April 17-22.

“Biogen is humbled that we were pioneers in developing the first treatment for SMA, along with our collaboration partners Ionis Pharmaceuticals. We continue to be driven by the pursuit of better outcomes for patients, including exploring the potential of a higher dose of SPINRAZA in the DEVOTE study, in addition to initiating the RESPOND study,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. “We are also evaluating the use of biomarkers and digital tools to supplement traditional clinical assessments for SMA and enhance disease monitoring. Through these collective research efforts, we aim to provide valuable data that may help guide future treatment approaches and decisions for people with SMA.”

Exploring Opportunities to Optimize Treatment in SMA

Building on the proven efficacy and well-established safety of SPINRAZA in a broad range of patients with SMA, the Phase 2/3 DEVOTE study is evaluating the safety, tolerability and potential for even greater efficacy of SPINRAZA when administered at a higher dose than currently approved. The three-part study includes an open-label safety evaluation cohort (Part A), a pivotal, double-blind, active control randomized treatment cohort (Part B) and an open-label cohort (Part C) transitioning from the approved 12-milligram (mg) dose of SPINRAZA to the higher dose.

An analysis of the higher loading and maintenance dosing regimen in Part A (n=6; 28 mg) showed no new safety concerns in study participants who were followed for up to approximately five months (64-158 days). There were no adverse events (AEs) reported that were considered related to the higher dose study drug and there were no severe or serious AEs. Four patients reported mild or moderate AEs, including AEs considered related to the treatment administration procedure. This emerging safety profile supports Biogen’s continued development of a higher dose of SPINRAZA, including ongoing enrollment of patients in the pivotal Part B of the DEVOTE study. This part will evaluate the higher-dose regimen (2 loading doses of 50 mg two weeks apart followed by 28 mg maintenance doses every four months) compared to the approved 12 mg dose of SPINRAZA: four loading doses, followed by maintenance doses every four months.¹ More information about DEVOTE is available at ClinicalTrials.gov (NCT04089566).

Using Biomarkers and Digital Tools to Enhance Disease Monitoring

Biogen is advancing research to evaluate biomarkers and digital tools that expand on traditional clinical assessments and incorporate more sensitive measures to help better predict and monitor the course of SMA.

New data in patients (n=75) from the CHERISH/SHINE studies build upon the body of evidence suggesting neurofilament levels – an indicator of ongoing biological disease activity – warrant further evaluation as a biomarker for treatment response in SMA. Data show that higher neurofilament levels at baseline were, on average, associated with greater improvements in motor function scores among SPINRAZA-treated individuals with later-onset SMA over a median of approximately four years. The use of biomarkers could improve the understanding of disease mechanisms and interventions for SMA and other neurological diseases. Therefore, measuring neurofilament levels have been integrated as an exploratory endpoint in the DEVOTE and RESPOND (NCT04488133) studies.

Additionally, in consultation with SMA experts, Biogen has developed a conceptual clinical framework to evaluate the potential value of Konectom™, a mobile application, to enable adults living with SMA to quantitatively and remotely self-assess motor function in their daily lives. Currently used only in research settings, Konectom leverages smart sensing technologies like touchscreen and accelerometry to capture tangible data in studying neurological diseases. In SMA, monitoring fatigue and smartphone typing skills may be useful to assess functional impact across a broad range of patients with varying levels of disease severity. Biogen is also studying Konectom’s potential utility in multiple sclerosis and other neurological diseases, with the goal of providing a more accurate and complete picture of how neurological diseases impact a person’s daily life.

SMA Data Presentations Featured at AAN:

• Escalating Dose and Randomized, Controlled Study of Nusinersen in Participants With Spinal Muscular Atrophy (SMA); Study Design and Part A Data for the Phase 2/3 DEVOTE (232SM203) Study to Explore High-Dose Nusinersen – P6.080
• Baseline Plasma Phosphorylated Neurofilament Heavy Chain (pNF-H) Level Is Associated With Future Motor Function in Nusinersen-treated Individuals With Later-onset Spinal Muscular Atrophy (SMA) – S13.005 – Monday, April 19, 2:40 p.m. ET
• Konectom™ Smartphone-Based Digital Outcome Assessments for Adults Living With Spinal Muscular Atrophy (SMA): A Conceptual Framework – P8.010

About SPINRAZA

^®

 (nusinersen)

SPINRAZA is approved to treat infants, children and adults with spinal muscular atrophy (SMA) and is available in more than 50 countries. As a foundation of care in SMA, more than 11,000 individuals have been treated with SPINRAZA worldwide.²

SPINRAZA is an antisense oligonucleotide (ASO) that targets the root cause of SMA by continuously increasing the amount of full-length survival motor neuron (SMN) protein produced in the body.¹ It is administered directly into the central nervous system, where motor neurons reside, to deliver treatment where the disease starts.¹

SPINRAZA has demonstrated sustained efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 7 years, combined with unsurpassed real-world experience.³ The SPINRAZA clinical development program encompasses 10 clinical studies, which have included more than 300 individuals across a broad spectrum of patient populations,³ including two randomized controlled studies (ENDEAR and CHERISH). The ongoing SHINE and NURTURE open-label extension studies are evaluating the long-term impact of SPINRAZA. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs.

Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), the leader in antisense therapeutics. Please click here for Important Safety Information and full Prescribing Information for SPINRAZA in the U.S., or visit your respective country’s product website.

About SMA

SMA is a rare, genetic, neuromuscular disease that affects individuals of all ages. It is characterized by a loss of motor neurons in the spinal cord and lower brain stem, resulting in progressive muscle atrophy and weakness.⁴ SMA is caused by a deficiency in the production of survival motor neuron (SMN) protein due to a damaged or missing SMN1 gene, with a spectrum of disease severity.⁴ Some individuals with SMA may never sit; some sit but never walk; and some walk but may lose that ability over time.⁵ In the absence of treatment, children with the most severe form of SMA would not be expected to reach their second birthday.⁴

SMA impacts approximately one in 11,000 live births in the U.S.,⁶ is a leading cause of genetic death among infants⁶ and causes a range of disability in teenagers and adults.⁵

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

Biogen Safe Harbor 

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential benefits, safety and efficacy of SPINRAZA; the results of certain real-world data; results from the DEVOTE study; the identification and treatment of SMA; our research and development program for the treatment of SMA; the potential benefits and results from early treatment of SMA and/or higher dose SPINRAZA; the enrollment of the DEVOTE study and the RESPOND study; the potential of our commercial business, including SPINRAZA; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation risks that we may not fully enroll the DEVOTE study and/or the RESPOND study or it will take longer than expected; uncertainty of success in the development and potential commercialization of higher dose SPINRAZA; unexpected concerns that may arise from additional data, analysis or results obtained during the DEVOTE study and/or the RESPOND study; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of higher dose SPINRAZA; the occurrence of adverse safety events; risks of unexpected costs or delays; the risks of other unexpected hurdles; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

References:

1. SPINRAZA U.S. Prescribing Information. Available at: https://www.spinraza.com/content/dam/commercial/specialty/spinraza/caregiver/en_us/pdf/spinraza-prescribing-information.pdf. Accessed: April 2021
2. Based on commercial patients, early access patients, and clinical trial participants through December 31, 2021. 
3. Core Data sheet, Version 9, January 2019. SPINRAZA. Biogen Inc, Cambridge, MA.
4. National Institute of Neurological Disorders and Stroke, NIH. Spinal Muscular Atrophy Fact Sheet. Available at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Spinal-Muscular-Atrophy-Fact-Sheet. Accessed: April 2021.
5. Wadman RI, Wijngaarde CA, Stam M, et al. Muscle strength and motor function throughout life in a cross-sectional cohort of 180 patients with spinal muscular atrophy types 1c–4. Eur J Neurol. 2018;25(3):512-518.
6. Cure SMA. About SMA. Available at https://www.curesma.org/about-sma/. Accessed: April 2021

MEDIA CONTACT: David Caouette + 1 617 679 4945 [email protected]

INVESTOR CONTACT: Mike Hencke  +1 781 464 2442  [email protected]

CHICAGO, April 19, 2021 (GLOBE NEWSWIRE) — FourKites, the #1 real-time supply chain visibility platform, today announced that it was named a Leader in the 2021 Gartner Magic Quadrant for Real-Time Transportation Visibility Platforms¹. Out of 14 vendors evaluated, FourKites was the only company positioned in the Leaders quadrant with the highest Completeness of Vision.

FourKites^® pioneered real-time transportation visibility in 2014, and is now leading the industry into a new era where global supply chains are powered and optimized by real-time visibility data and machine learning. Recognized as a “company of firsts,” FourKites delivered more than 120 new products and features in 2020 alone, including a number of industry-firsts such as multimodal end-to-end purchase order tracking; Appointment Manager^SM, an automated appointment scheduling platform for facilities, shippers and carriers; a new software category — Dynamic Yard^® — that extends visibility into warehouses and yards; and Dynamic Ocean^SM, a next-generation international ocean visibility solution that encompasses advanced document management capabilities, robust collaboration features and support for bookings, with superior end-to-end real-time tracking.

Through its recent $100 million Series D financing round, led by Thomas H. Lee Partners, L.P., with strategic investors including Qualcomm Ventures, LLC, Volvo Group Venture Capital AB and Zebra Technologies, FourKites is now poised to fuel a broader vision for the future of digital supply chains — one that connects the physical and digital worlds of warehouses, stores and transportation to enable true end-to-end visibility and unlock tremendous value for the entire ecosystem fueling even greater automation and collaboration.

“FourKites’ recognition as a Leader in the Gartner Magic Quadrant follows a year of record growth, momentum and technological innovation, driven in close collaboration with customers,” said Mathew Elenjickal, founder and CEO of FourKites. “This is a testament to the value we continue to bring to our customers, and recognition of our vision for the future of supply chain management and automation — one that focuses on eliminating barriers across supply chains and delivering true, end-to-end global supply chain visibility.”

Collaboration with the world’s largest shippers continues to play a critical part in FourKites’ technology roadmap, as together with its customers FourKites innovates and delivers solutions that address the industry’s most pressing needs. In the last year alone, FourKites released the industry’s first end-to-end purchase order lifecycle tracking solution, which was developed in conjunction with Meijer, one of the largest food retailers and wholesalers in the country. In addition, FourKites partnered with Cardinal Health to build a cognitive supply chain and serve as the company’s central data hub to create a fast, reliable and frictionless experience for the 29,000 pharmacies and nearly 90 percent of American hospitals that depend upon Cardinal Health for critical supplies.

“Delivery of healthcare products directly impacts patients, and ensuring these products reach their destinations on time and in full has never been more critical. This type of transparency helps build trust in the connection between the Cardinal Health supply chain and our customers,” said Sean Halligan, Senior Vice President of Pharmaceutical Operations at Cardinal Health. “By partnering with FourKites, we will have end-to-end visibility to see products in transit and make any necessary adjustments to provide a frictionless experience to our customers everywhere and help them better serve their patients.”

Today, the FourKites platform tracks more than 2 million shipments per day for some of the world’s largest companies including Coca-Cola, Dow, Eastman, PetSmart, The Michaels Companies, Land O’Lakes, AB InBev, Constellation Brands and 3M. FourKites saw demand for its superior network of logistics tracking data and proprietary machine learning technology surge in 2020, as evidenced by record global growth in new shipping customers across all major verticals. In 2020, FourKites saw:

• Greater than 100% growth in total shipment volumes, including ocean load growth of 149%, and rail and intermodal growth of 49%.
• International load volume growth of 200%, including a 400%+ increase in tracked loads in EMEA and 95%+ growth in LATAM.
• 67% increase in carriers onboarded, with more than 350 carriers, brokers and 3PLs qualifying as Premier Carriers.
• 63% increase in the number of drivers — now totaling 377,000 individuals — using its CarrierLink mobile app.
• Greater than 70% growth in connected facilities, now totaling over 6 million individual facilities.

The Gartner report also highlighted FourKites’ strong customer presence across key verticals, including food and beverage, consumer packaged goods, chemicals, manufacturing, paper and packaging, pharmaceuticals and retail as one of the key strengths that helps us qualify as a partner of choice. FourKites works with more enterprise companies valued at over $1 billion than any other vendor in the Magic Quadrant, and the company has received the highest volume of four and five-star reviews on Gartner Peer Insights (specifically, of 96 reviews as of April 19, 2021, 97% are four- and five-star ratings), a platform for public peer reviews on solutions.

What customers are saying on Gartner Peer Insights:

• “The visibility platform’s multimodal global capabilities enables our organization to have a single pane of glass across the globe. This coupled with FourKites customer-focused product roadmap makes our organization comfortable with the abilities in place today and excited about the future potential.” – Supply Chain Architect in Manufacturing
• “The product is a game-changer in that we now can tell where our client’s freight is at any time. In the past, we had to rely on our carriers to communicate via phone/email these updates which is way too manual. For our clients, they expect us to be proactive and FourKites gives us that capability.” – Sourcing, Procurement & Vendor Management in Transportation
• “We are finding great value in letting the FourKites system do the work behind the scenes. FourKites allows our business to focus on value-added processes and alert them to only desired urgent issues.” – Supply Chain Manager in Manufacturing

Gartner Disclaimer:

Gartner does not endorse any vendor, product or service depicted in our research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

About FourKites

FourKites^® is the #1 supply chain visibility platform in the world, extending visibility beyond transportation into yards, warehouses, stores and beyond. Tracking more than 2 million shipments daily across road, rail, ocean, air, parcel and courier, and reaching 176 countries, FourKites combines real-time data and powerful machine learning to help companies digitize their end-to-end supply chains. More than 500 of the world’s most recognized brands — including half of the Fortune 500, 9 of the top-10 CPG and 18 of the top-20 food and beverage companies — trust FourKites to transform their business and create more agile, efficient and sustainable supply chains.

To learn more about FourKites, visit https://www.fourkites.com.

Media Contact:

Marianna Vyridi
Big Valley Marketing for FourKites
(650) 468-3263
[email protected]   

¹
Gartner,
“Magic Quadrant for Real-Time Transportation Visibility Platforms,” Bart De Muynck, Carly West, 14 April 2021.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b24fd939-0d4c-42ed-b1d5-61cc8dbf9adf

GAITHERSBURG, Md., April 19, 2021 (GLOBE NEWSWIRE) — Arcellx, a privately held clinical-stage biopharmaceutical company, today announced that it has hired two new executives to join the company’s leadership team. Dr. Christopher Heery has been named Chief Medical Officer (CMO) where he will have responsibility for clinical, regulatory and medical affairs and Neeraj Teotia has been named Chief Commercial Officer where he will have responsibility for marketing, sales, and health economics and reimbursement.

“We are excited to strengthen our leadership team with the additions of Chris and Neeraj as they bring significant expertise to Arcellx and reflect our values and culture. They will lead two critically important areas — advancing our clinical programs to meet all requirements for regulatory approvals and ensuring successful commercialization post approval,” said Rami Elghandour, Chairman and Chief Executive Officer of Arcellx. “Chris will lead our talented clinical and regulatory teams in progressing our clinical pipeline by executing our CART-ddBCMA pivotal study in multiple myeloma, initiating a Phase 1 study for our novel ARC-SparX program in multiple myeloma later this year and planning our anticipated Phase 1 ARC-SparX study in acute myelogenous leukemia that is targeted to start in 2022. In concert with these clinical programs progressing, Neeraj will lead the development of our commercial strategy and build our commercial teams to successfully execute our growth plans.”

Dr. Heery has developed significant expertise in cellular therapies through his time at Precision Biosciences and the National Cancer Institute (NCI) where he led numerous programs through clinical trials. As the CMO at Precision Biosciences he oversaw the clinical development of one of the first allogeneic CAR-T cell platforms and provided clinical insight into efforts for their gene editing therapeutics. Prior to his most recent role at Precision Biosciences, Dr. Heery was the CMO of Bavarian Nordic where he oversaw clinical development programs for their immune-oncology and infectious disease vaccine portfolio.

Before moving into industry, Dr. Heery was Head of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology at NCI. During his time at the NCI he was part of the larger effort of the Laboratory of Tumor Immunology and Biology to create new immunotherapies for the treatment of cancer. Dr. Heery is board certified in Medical Oncology and Internal Medicine and completed his internal medicine residency at the University of Illinois at Chicago after receiving his M.D. from East Carolina University Brody School of Medicine. Dr. Heery also holds a B.A. in English Literature from Duke University.

Mr. Teotia joins Arcellx with more than 20 years of experience in the healthcare industry. Most recently he served as the Vice President of Marketing at Nevro where he and his team set and helped execute commercial plans for a rapidly growing business that grew over 10x during his tenure. His responsibilities included product and clinical portfolio strategy, branding, demand generation, key thought leader engagement, professional education, sales forecasting and analytics, sales management, sales training, and market access. Prior to Nevro, Mr. Teotia worked at Johnson & Johnson where he had various roles of increasing responsibility within Marketing, Licensing & Acquisitions and Research & Development. Mr. Teotia received an M.B.A. from the Kellogg School of Management at Northwestern University and has a B.S. in Electrical Engineering from the University of Illinois at Urbana-Champaign.

“The additions of Chris and Neeraj emphasize our commitment to building a leading organization in cell therapy and advancing our novel pipeline. We believe the innovations we are bringing to the clinic will help advance and expand patient care and adding experienced leaders like Chris and Neeraj will ensure we maximize the impact of our therapies to the benefit of the physicians and patients we serve,” said Rami Elghandour.

About Arcellx, Inc.

Arcellx is a clinical-stage biopharmaceutical company developing adaptive and controllable cell therapies for the treatment of patients with cancer and autoimmune diseases. The Arcellx vision is to utilize our novel proprietary platform to bring superior cell therapies to more patients through the care of academic and community practices worldwide. More information can be found at www.arcellx.com.

Contact:

Media:

Zara Lockshin
Solebury Trout
646-378-2960
[email protected]  

Investors:

Alan Lada
Solebury Trout
646-378-2927
[email protected]