EU to Review Regeneron's Lymphoma Drug Odronextamab
Westchester-headquartered Regeneron Pharmaceuticals Inc. announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for its lymphoma treatment Odronextamab.
Odronextamab is designed for adult patients with the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL), relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL). Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
According to Regeneron, the EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL. The MAA is supported by data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2) investigating odronextamab in FL and DLBCL, which were presented last December at the 64th American Society of Hematology Annual Meeting.
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Regeneron Announces Updates to Board of Directors
Regeneron Pharmaceuticals, Inc. announced that Kathryn Guarini, Ph.D., and David P. Schenkein, M.D., have joined Regeneron’s Board of Directors effective September 8, 2023.
Kathryn Guarini, Ph.D., who will serve as an Independent Director, recently retired as Chief Information Officer of IBM. Prior to her role as CIO which began in 2021, Dr. Guarini served in multiple executive leadership roles at IBM over more than 20 years, including Chief Operating Officer of IBM Research and Vice President of Product Management for IBM Systems.
David P. Schenkein, M.D., is a General Partner and Co-lead of the Life Sciences team at GV (Google Ventures). Prior to joining GV in 2019, Dr. Schenkein served as Chief Executive Officer for Agios Pharmaceuticals, Inc. for 10 years. He is currently a Board Member of Prime Medicine, Inc., Denali Therapeutics, Inc. and Agios.
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