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Poseida Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for P-BCMA-101SAN DIEGO, Nov. 05, 2018 (GLOBE NEWSWIRE) -- Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company focused on leveraging proprietary next-generation, non-viral gene engineering technologies to create life-saving therapeutics, today announced the U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-101, Poseida’s lead CAR-T therapeutic candidate currently in a Phase 1 clinical trial for the treatment of patients with relapsed/refractory multiple myeloma. RMAT designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA. “P-BCMA-101 is the first anti-BCMA CAR-T therapy to receive RMAT designation from the FDA and underscores the urgent need for new treatment options for multiple myeloma,” said Eric Ostertag, M.D., Ph.D., chief executive officer of Poseida Therapeutics. “Initial Phase 1 data presented at the CAR-TCR Summit earlier this year included encouraging response rates and safety data, including meaningful responses in a heavily pretreated population, with some patients reaching VGPR and stringent CR. We expect to have an additional data update by the end of the year and look forward to working closely with the FDA to expedite development of P-BCMA-101.” The RMAT designation is a program under the 21st Century Cures Act that is intended to expedite the development and review of regenerative medicines for the treatment of serious or life-threatening diseases and conditions. A regenerative medicine therapy is eligible or the designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product has the potential to address unmet medical needs for such a disease or condition. RMAT designation includes all Breakthrough Therapy designation features, including early interactions to discuss any potential surrogate or intermediate endpoints. RMATs may be eligible for accelerated approval based on previously agreed-upon surrogate or intermediate endpoints that are reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate. About P-BCMA-101 About Poseida Therapeutics, Inc. Corporate Communications Contacts: Jason Spark |