Adaptive Biotechnologies, Genentech announce FDA acceptance of investigational new drug application

By The Science Advisory Board staff writers

May 9, 2023 -- Adaptive Biotechnologies on Tuesday announced that the U.S. Food and Drug Administration (FDA) has accepted an investigational new drug (IND) application submitted by its collaborator, Genentech, for a neoantigen-directed T-cell receptor (TCR)-based T-cell therapy.

This IND is the first TCR-based therapy drug candidate to advance to clinical development from Adaptive Biotechnologies' oncology collaboration with Genentech, a member of the Roche Group.

Under the terms of the collaboration agreement signed in 2019, Genentech has responsibility for clinical, regulatory, and commercialization efforts for any T-cell therapy product candidate.

The collaboration utilizes Genentech's cancer immunotherapy research and development expertise and Adaptive's proprietary T-cell receptor (TCR) discovery platform, with the aim of developing tailored cellular therapy for each patient's individual cancer, the firms said.

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