Sangamo Therapeutics announced the completion of the transfer to Pfizer of the SB-525 Hemophilia A gene therapy Investigational New Drug application (IND). Pfizer is advancing SB-525 into a Phase 3 registrational clinical study in 2020 and has already commenced enrolling patients into a Phase 3 lead-in study. Sangamo has now earned a $25 million milestone payment, per the terms of a December 2019 amendment to the parties’ collaboration agreement for the global development and commercialization of gene therapies for Hemophilia A.

"I want to congratulate our team for their success in developing SB-525 through to this important milestone where we have handed over the IND to Pfizer for Phase 3 development," said Sandy Macrae, CEO of Sangamo. "We are thrilled to be in a partnership where both parties have cooperated to accelerate study timelines, resulting in completion of the IND transfer ahead of schedule. Pfizer and Sangamo are united in our common interest to help patients with Hemophilia A and will do everything that we can to safely and expeditiously advance this promising gene therapy candidate for patients in need."

The SB-525 collaboration was established in May 2017. Under the terms of the collaboration agreement, Sangamo has been responsible for Phase 1/2 clinical development. Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization activities for SB-525. Sangamo is eligible to receive total potential milestone payments of up to $300 million for the development and commercialization of SB-525, and up to $175 million for additional Hemophilia A gene therapy product candidates that may be developed under the collaboration. Sangamo will, additionally, receive tiered royalties starting in the low teens and up to 20% of annual net sales of SB-525.

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