Genomic medicine company Sangamo Therapeutics, Inc. (SGMO) Monday announced that it will regain development and commercialization rights to giroctocogene fitelparvovec that it has co-developed with and licensed to Pfizer Inc. (PFE)
Giroctocogene fitelparvovec is an investigational gene therapy product candidate for the treatment of adults with moderately severe to severe hemophilia A.
The announcement follows Pfizer's decision 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.
"Giroctocogene fitelparvovec has demonstrated the potential to be a life changing gene therapy treatment for hemophilia A patients, and following positive results from the Phase 3 AFFINE trial, we believe it is well positioned for regulatory submissions and potential commercialization," said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics.
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