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Poseida Therapeutics Receives US FDA Orphan Drug Designation for P-BCMA-101 for the Treatment of Multiple MyelomaSAN DIEGO, May 13, 2019 (GLOBE NEWSWIRE) -- Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to P-BCMA-101 for the treatment of relapsed and/or refractory multiple myeloma. P-BCMA-101 is an autologous CAR-T therapy developed using Poseida’s piggyBac® platform technology. P-BCMA-101 is comprised of a high percentage of long-lived, self-renewing stem cell memory T cells targeting cancer cells expressing B-cell maturation antigen (BCMA). “FDA orphan designation is an important regulatory milestone in the continued development and commercialization of P-BCMA-101,” said Eric Ostertag, M.D., Ph.D., chief executive officer of Poseida. “P-BCMA-101 has demonstrated outstanding potency, with strikingly low rates of toxicity in our phase 1 clinical trial. In fact, the FDA has approved fully outpatient dosing in our Phase 2 trial starting in the second quarter of 2019.” Poseida’s non-viral piggyBac DNA Modification System results in CAR-T product candidates with a high percentage of stem cell memory T cells (Tscm), the only T cell that is self-renewing and long-lived, leading to CAR-T products with improved efficacy, lower toxicity and potentially greater durability than earlier generation CAR-T therapies. Orphan drug designation is granted by the FDA Office of Orphan Products Development to drugs and biologics which are intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits and seven years of market exclusivity in the United States following marketing approval by the FDA. About Poseida Therapeutics, Inc. Contacts: Jason Spark |