Efmoroctocog alfa(Sobi Analytics)

WELLESLEY, Mass., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM) today announced the appointment of Douglas E. Williams, Ph.D., as Climb Bio’s Chair of its Board of Directors. Dr. Williams will assume the role of Chair of the Board, succeeding Andrew Levin, who will remain on the Board as a director, while Liam Ratcliffe will step down from his position as a director. Dr. Williams has over 30 years of executive leadership experience in the biotechnology sector. Throughout his career, Dr. Williams has held leadership roles in research and development, contributing significantly to the creation of drugs such as Leukine®, Enbrel®, Adcetris®, Tecfidera®, Alprolix®, Eloctate® and Spinraza®. As a CEO, he has successfully guided both private and public companies from development to commercialization and has overseen multiple successful mergers. “I am thrilled to welcome Dr. Doug Williams to Climb Bio. As our incoming Chair of the Board, Doug’s experiences over his 30 plus year career building and leading a range of biotechnology and pharmaceutical companies will offer critical perspective as we grow Climb Bio,” said Aoife Brennan, President and CEO of Climb Bio. “In particular, Doug’s expertise in immunology drug development will be very valuable as we pursue our mission to develop better treatments for the approximately 50 million patients in the U.S. and many more globally living with immune-mediated diseases.” Dr. Williams previously served as the President of Research and Development at Sana Biotechnology and was CEO of Codiak BioSciences. He has also served as Executive Vice President of Research and Development at Biogen. Prior to Biogen he was CEO at ZymoGenetics and led its acquisition by Bristol Myers Squibb. He has also held a variety of leadership positions, including Chief Scientific Officer and Executive Vice President of Research and Development at Seattle Genetics (acquired by Pfizer in 2023), Senior Vice President and Washington Site Leader at Amgen and Executive Vice President and Chief Technology Officer and a member of the Board of Directors at Immunex (acquired by Amgen in 2021). Dr. Williams has served as a board member of more than a dozen public and private biotechnology companies and is currently Chair of the Board of AC Immune SA and a Director of Stablix. He holds a Ph.D. from the State University of New York at Buffalo, Roswell Park Division and completed a postdoctoral fellowship at Indiana University School of Medicine. Dr. Williams added: “I am honored to be joining Climb Bio’s Board at this exciting time as they work to advance budoprutug and build a leading immune-mediated disease focused company. I believe budoprutug has potential across a broad range of B-cell mediated diseases and provides a cornerstone for the company to expand. I look forward to working with the talented Climb Bio team and the board to help them advance their mission to develop therapeutics for patients with immune-mediated diseases.” “I look forward to continuing to work with Aoife, the Climb Bio team, and other board members,” stated Andrew Levin, a member of Climb Bio’s Board and former Chair of the Board. “In the short time since acquiring Tenet Medicines, we have achieved a great deal. With the tremendous opportunity ahead, I am excited to transition the Chair role to Doug while remaining on the Board. Doug has incredible experience and a proven track record in building successful biotechnology companies and will be invaluable in guiding Climb Bio going forward. In addition, on behalf of the Board, I would also like to thank Liam for his valuable contributions and commitment to the Company through its transition.” About Climb Bio, Inc. Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Company’s lead product candidate, budoprutug, is an anti-CD19 monoclonal antibody that has demonstrated B-cell depletion and has potential to treat a broad range of B-cell mediated diseases. For more information, please visit climbbio.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Climb Bio; the anticipated benefits of the acquisition of Tenet Medicines, Inc.; expectations regarding budoprutug’s therapeutic benefits, clinical potential and clinical development; plans to optimize the administration of budoprutug; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “will,” “working” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. Climb Bio 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. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its acquisition of Tenet Medicines, Inc.; changes in applicable laws or regulation; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; Climb Bio’s ability to advance budoprutug on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials of budoprutug; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia and systemic lupus erythematosus and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug and/or its other product candidates; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law. InvestorsChris Brinzey ICR Healthcarechris.brinzey@icrhealthcare.com 339-970-2843 MediaJon YuICR Healthcarejon.yu@icrhealthcare.com475-395-5375

XTEND-Kids is the first assessment of once-weekly ALTUVOCT® prophylaxis in previously treated children Results indicate highly effective bleed protection in children under 12 years of age with severe haemophilia A STOCKHOLM, July 18, 2024 /PRNewswire/ -- Sobi® today announced the publication of full results from the Phase 3 XTEND-Kids study in The New England Journal of Medicine (NEJM) confirming the safety and efficacy profile of ALTUVOCT® (efanesoctocog alfa), in children younger than 12 years old with severe haemophilia A. The study demonstrated that fixed-dose once-weekly prophylaxis with ALTUVOCT, a new class of high-sustained factor VIII therapy, provided highly effective bleed protection in children. "Children represent a population for which it has been historically difficult to achieve effective bleed prevention," said Lynn Malec, MD, Medical Director of Comprehensive Center for Bleeding Disorders and Associate Investigator at The Versiti Blood Research Institute, and Associate Professor of Medicine and Paediatrics at The Medical College of Wisconsin. "The clearance of administered factor concentrates is greater in children than we see in adults, which leads to burdensome treatment regimens involving multiple injections per week. By providing high-sustained factor VIII activity levels consistently early in life with once-weekly dosing, ALTUVOCT has the potential to improve reported outcomes for children living with haemophilia." Published in NEJM, the pivotal XTEND-Kids study shows ALTUVOCT met primary and key secondary endpoints, which included occurrence of factor VIII inhibitors and annualised bleed rates (ABRs). Results revealed no development of factor VIII inhibitors and sustained protection from bleeding events with once-weekly dosing. These findings support the value of sustaining high factor levels with ALTUVOCT in children with haemophilia A. "The recent XTEND-Kids study further underscores the safety and effectiveness of ALTUVOCT, showcasing how high-sustained factor VIII activity can improve clinical outcomes in children," said Lydia Abad-Franch, MBA, Head of Research, Development, and Medical Affairs, and Chief Medical Officer at Sobi. "Maintaining normal factor VIII levels in the non-haemophilia range for a significant part of the week effectively reduces the occurrence of any type of bleed and enables people with haemophilia to lead more active lives. Today's announcement reinforces our enduring commitment to transforming standards of care across all ages within the haemophilia community." For patients treated per protocol (n=73), the estimated mean (95% CI) and median [interquartile range (IQR)] overall ABRs were 0.61 (0.42–0.90) and 0.00 (0.00–1.02), respectively. In 95% of cases bleeding episodes (41/43) resolved with one ALTUVOCT injection. The majority (64%) of patients had zero bleeding episodes, 84% of patients had zero joint bleeds and 88% of patients had zero spontaneous bleeds. ALTUVOCT prophylaxis provided high-sustained factor VIII activity in the non-haemophilia range (above 40%) for three days. In the study, ALTUVOCT was well tolerated. Development of factor VIII inhibitors was not detected (0% [95% confidence interval (CI)] 0–4.9]), and no adverse events led to treatment discontinuation. The most common treatment-emergent adverse events (>10%) were SARS-CoV-2 test positive, upper respiratory tract infection, and fever (pyrexia). No serious allergic reactions, anaphylaxis, or embolic or thrombotic events were reported. About Haemophilia A Haemophilia A is a rare, lifelong genetic condition in which the body does not produce enough, or makes dysfunctional, factor VIII – a protein that is essential for blood clotting. It occurs in about one in 5,000 male births annually, and more rarely in females. People with haemophilia can experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages. About XTEND-Kids XTEND-Kids was an open-label, non-randomised interventional, single-arm study. Participants received a weekly prophylactic dose of ALTUVOCT® for 52 weeks. XTEND-Kids evaluates efficacy, safety, and pharmacokinetics in 74 previously treated patients <12 years of age with severe haemophilia A. About ALTUVOCT® ALTUVOCT® (efanesoctocog alfa) [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is the first high-sustained FVIII replacement therapy with the potential to deliver near-normal factor activity levels for a significant part of the week, improving bleed protection in a once-weekly dose for people with haemophilia A. ALTUVOCT builds on the established Fc fusion technology by innovatively adding a region of von Willebrand factor and XTEN® polypeptides to extend its time in circulation. It is the only therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. The European Commission granted Orphan Drug designation in June 2019. It is approved and marketed as ALTUVOCT by Sobi in Europe. It is approved and marketed as ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] by Sanofi in the United States, Japan, and Taiwan. About the Sanofi and Sobi collaboration Sobi and Sanofi collaborate on the development and commercialisation of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialisation of ALTUVOCT® (efanesoctocog alfa), or ALTUVIIIO™ in the US. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the centre of our ambitions. Sanofi is listed on EURONEXT: SAN andNASDAQ: SNY Sobi® Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: