Precision BioSciences Receives Fast Track Disease Designation from U.S. Food and Drug Administration for PBCAR0191 Investigational Allogeneic CAR T Cell Therapy

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[{"type":"text","content":"DURHAM, N.C., Aug. 19, 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 Precision for PBCAR0191, the company’s lead investigational allogeneic chimeric antigen receptor (CAR T) cell therapy for the treatment of advanced B-cell precursor acute lymphoblastic leukemia (B-ALL).\n “Fast Track Designation is intended to fill an unmet medical need by accelerating the development of agents for patients in need of potentially better therapeutic options,” said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “We continue to work toward demonstrating that PBCAR0191, as well as our other two allogeneic CAR T clinical programs, may play a role in the treatment paradigm of advanced malignancies in the future. We believe the balance of safety and efficacy plus the accessibility of allogeneic cell therapies may fill a void left by autologous CAR T therapies. This designation provides more flexibility as we attempt to identify the optimal patient population in which to seek regulatory approval.” 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 PBCAR0191 Clinical TrialPBCAR0191 is being evaluated in a Phase 1/2a multicenter, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and tolerability of PBCAR0191 in adult patients with R/R B-cell acute lymphoblastic leukemia (B-ALL) and R/R non-Hodgkin lymphoma (NHL). The NHL cohort includes patients with mantle cell lymphoma, an aggressive subtype of NHL, for which the FDA previously granted Orp...

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