Sangamo Therapeutics, Inc., a genomic medicine company, will regain development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy candidate for the treatment of hemophilia A that was being co-developed with, and licensed to Pfizer. Pfizer decided to terminate the global collaboration and license agreement between the parties. Sangamo plans to explore all options to advance the program, including seeking a potential new collaboration partner. 

Pfizer’s decided not to proceed with the Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions for, or to pursue commercialization of, giroctocogene fitelparvovec.

In July 2024, Pfizer announced positive 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. 

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.

“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.”

The collaboration and license agreement with Pfizer will terminate effective April 21, 2025, at which time Pfizer will be required to transition the giroctocogene fitelparvovec program back to Sangamo. All trial participants will continue to be monitored as planned during the transition period.