November 27, 2018

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Precision BioSciences Receives FDA Authorization to Initiate Clinical Study of Gene Edited Cancer Immunotherapy


Precision BioSciences and Servier today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for PBCAR0191, an allogeneic anti-CD19 CAR T therapy for B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL).

Upon trial initiation, PBCAR0191 will be Precision’s first clinical-stage product candidate.

Precision’s PBCAR0191 is currently positioned to be the first gene-edited allogeneic CAR T product candidate in human clinical trials for NHL. Data that was provided to the FDA in connection with the IND submission included results of in depth off target cutting analyses and evidence to support the elimination of graft versus host interactions. Manufacturing data were provided to the FDA in support of the scalability and reproducibility of the T-cell genome editing production process. Precision is currently producing clinical trial material at full scale with its manufacturing partner.

T cells are a major development in the fight against cancer and are engineered to transport a tumor-targeting chimeric antigen receptor (CAR). This has the potential to save many patients who have been unresponsive to traditional chemotherapy and radiation regimens. Autologous CAR T therapies currently on the market rely on patient-derived T cells, which are extracted and individually manufactured for each patient using that patient’s own cells, which involves a complex and lengthy process.

“Our allogeneic CAR T program has exceeded all expectations, moving from concept to IND acceptance in under three years,” said Matt Kane, Chief Executive Officer of Precision. “We are thrilled to have received authorization to initiate clinical studies for a therapy that we believe could be transformative for patients suffering with NHL and B-ALL.”

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[Originally posted by  Precision Biosciences — November 27, 2018