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Precision BioSciences Receives Fast Track Designation from U.S. Food and Drug Administration for PBCAR269A, an Investigational Allogeneic CAR T Therapy for Relapsed/Refractory Multiple Myeloma
DURHAM, N.C., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving
About this update from Precision Biosciences, Inc.
[{"type":"text","content":"DURHAM, N.C., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS® genome editing platform, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PBCAR269A for the treatment of relapsed/refractory multiple myeloma. This is the company’s second allogeneic chimeric antigen receptor (CAR T) cell therapy to receive Fast Tack Designation for which the FDA previously granted Orphan Drug Designation.\n “Fast Track Designation will help us expedite our allogeneic CAR T cell therapy program aimed to address the unmet medical need among patients with relapsed/refractory multiple myeloma,” said Chris Heery, M.D., Chief Medical Officer of Precision BioSciences. “We look forward to working more closely with the FDA as we continue to investigate PBCAR269A as a potential new treatment option that can be more broadly available to patients who otherwise may be ineligible or unable to access existing autologous CAR T therapies.” About Fast Track DesignationFast Track Designation facilitates the expedited development and review of a new drug, whether alone or in combination with another drug that may address unmet medical needs and treats a serious or life-threatening disease. Benefits of this designation include more frequent engagements with the FDA to discuss the drug’s clinical development plan, eligibility for Accelerated Approval and Priority Review, and a Rolling Review in which Precision can submit completed sections of its New Drug Application (NDA) for review by the FDA rather than waiting to complete the NDA before it can be submitted for review. About the PBCAR269A Clinical TrialPBCAR269A is being evaluated in a Phase 1/2a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A in adults with relapsed/refractory multiple myeloma. The starting dose of PBCAR269A is 6 x 105 CAR T cells/kg body weight with subsequent cohorts treated with escalating doses to a maximum dose of 6 x 106 CAR T cells/kg body weight. The trial is being conducted at multiple U.S. sites with clinical trial material generated in-house at the Manufacturing Center for Advanced The...