 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 companys lead investigational allogeneic chimeric antigen receptor CAR T cell therapy for the treatment of advanced B-cell precursor acute lymphoblastic leukemia B-ALL. 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 Designation Fast 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 drugs 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 Trial PBCAR0191 is being evaluated in a Phase 12a multicenter, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and tolerability of PBCAR0191 in adult patients with RR B-cell acute lymphoblastic leukemia B-ALL and RR non-Hodgkin lymphoma NHL. The NHL cohort includes patients with mantle cell lymphoma, an aggressive subtype of NHL, for which the FDA previously granted Orphan Drug Designation. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company. For more information, visit study identifier number NCT03666000.About Precisions Allogeneic CAR T Platform Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor TCR locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured that is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.About Precisions Collaboration with Servier Under the terms of the agreement with Servier, Precision is solely responsible for early-stage research activities and Phase 1 execution for PBCAR0191, as well as preparation of clinical supply for any Phase 2 clinical trials. Servier has the exclusive right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 5050 co-development and co-promotion option in the United States.About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life DTIL with its novel and proprietary ARCUS genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Companys pipeline consists of multiple off-the-shelf CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no known adequate treatments exist. For more information about Precision BioSciences please visit Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Companys timing of, results from and information involving the Companys clinical trials involving PBCAR0191, PBCAR20A and PBCAR269A, and details of our manufacturing process. In some cases, you can identify forward-looking statements by terms such as anticipate, believe, could, designed to, expect, should, plan, intend, estimate, target, mission, may, will, would, should, could, target, project, predict, contemplate, potential, or the negative thereof and similar words and expressions.Forward-looking statements are based on managements current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. 