Pfizer ceases development of Hemophilia A gene therapy Giroctocogene Fitelparvovec
Richmond: Sangamo Therapeutics, Inc., a genomic medicine company, has announced it will regain development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy product candidate for the treatment of adults with moderately severe to severe hemophilia A that it has co-developed with, and licensed to Pfizer Inc., following a decision by Pfizer to terminate the global collaboration and license agreement between the parties.
Sangamo intends to explore all options to advance the program, including seeking a potential new collaboration partner. Pfizer has indicated to Sangamo that this termination reflects its decision not to proceed with the Biologics License Application (BLA) and Marketing Authorisation Application (MAA) submissions for, or to pursue commercialization of, giroctocogene fitelparvovec.
In July 2024, Pfizer announced positive topline results from the Phase 3 AFFINE trial evaluating giroctocogene fitelparvovec that demonstrated the trial met primary and key secondary objectives of superiority compared to prophylaxis. OnDecember 9, 2024, Pfizer presented detailed AFFINE data in an oral presentation at the 66th ASH Annual Meeting and Exposition, with the presentation selected as part of the “Best of ASH” program, which highlights the most cutting-edge science presented during the Annual Meeting. In November 2024 Pfizer indicated to Sangamo that Pfizer was discussing these data with regulatory authorities. Pfizer previously indicated to Sangamo that anticipated BLA and MAA submissions were expected to occur in early 2025.
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