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FDA Accepts IND Application for PBCAR19B

December 30, 2021

The FDA cleared Precision BioSciences' Investigational New Drug (IND) application for its chimeric antigen receptor (CAR) T-cell therapy PBCAR19B. The company will initiate a phase I trial evaluating the safety and clinical activity of PBCAR19B at increasing flat dose levels (2.7-8.1×108 CAR T cells) in patients with relapsed or refractory non-Hodgkin lymphoma.

Manufactured from healthy donor cells using the company's proprietary ARCUS genome editing platform, PBCAR19B is designed to improve the persistence of allogeneic CAR T cells after infusion by preventing rejection by a patient's T cells and natural killer cells.

"We are pleased to receive IND clearance for PBCAR-19B, which has shown in preclinical studies to delay both T cell and natural killer cell-mediated allogeneic rejection," said Matt Kane, CEO of Precision BioSciences. "We believe that the ability to reduce rejection by both cell types holds potential for improved persistence of allogeneic CAR T cells."

Source: Precision BioSciences press release, January 19, 2021.

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