Precision BioSciences, a clinical stage biotechnology company, announced that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for PBCAR19B, a next-generation, stealth cell, CD19 product candidate for patients with relapsed/refractory (R/R) Non-Hodgkin lymphoma (NHL).“We are pleased to receive IND clearance for PBCAR19B, which has shown in preclinical studies, to delay both T cell and natural killer cell-mediated allogeneic rejection,” said Matt Kane, chief executive officer 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 and that, by bringing PBCAR19B into the clinic while continuing to develop our lead allogenic candidate PBCAR0191, we have two opportunities to achieve our goal of producing deep and durable clinical responses.”The phase 1 study will be a non-randomized, open-label, single-dose, dose-escalation and dose-expansion study deigned to evaluate the safety and clinical activity of PBCAR19B at increasing flat dose levels (2.7 x 108 - 8.1 x 108 CAR T cells) in patients with R/R NHL. The primary objective of the study is to identify the maximum tolerated dose and any dose-limiting toxicities.PBCAR19B is a next-generation, stealth cell candidate for patients with CD19-positive malignancies such as relapsed/refractory Non-Hodgkin Lymphoma. PBCAR19B is designed to improve the persistence of allogeneic CAR T cells following infusion by preventing rejection by T cells and natural killer (NK) cells. In addition to the CAR gene, the stealth vector carries a short hairpin RNA (shRNA) that suppresses expression of beta-2 microglobulin (B2M), a component of Class 1 major histocompatibility complex (MHC) molecules found on the cell surface. Reducing or knocking down Class 1 expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic T cells. The stealth vector also carries a HLA-E gene intended to prevent rejection of CAR T cells by NK cells that can be stimulated as a result of reduced MHC molecule expression on the cell surface.
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