On January 25, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage biotechnology company dedicated to improving life with its wholly proprietary ARCUS genome editing platform, reported it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering PBCAR19B, a next-generation, stealth cell, CD19 product candidate for patients with relapsed/refractory (R/R) Non-Hodgkin Lymphoma (NHL) (Press release, Precision Biosciences, JAN 25, 2021, View Source [SID1234574253]).
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The allowed composition claims of U.S. Patent Application No. 16/908,030 encompass genetically-modified human T cells comprising the Company’s PBCAR19B construct, which is inserted within the T cell receptor alpha constant (TRAC) locus. Once issued, patents arising from this patent family will have standard expiration dates in April 2040.
"This patent, when issued, will cover important design elements of our PBCAR19B stealth cell candidate, which is engineered to knock down expression of beta-2 microglobulin to reduce killing of CAR T cells by cytotoxic T cells, and to reduce CAR T cell rejection by natural killer cells," said Derek Jantz, Ph.D., Chief Scientific Officer and Co-Founder of Precision BioSciences. "Additionally, PBCAR19B CAR T cells are generated using a single gene editing step by inserting one cassette, encoding all the necessary elements, into the TRAC locus. Not only will this patent strengthen our intellectual property portfolio, it will further distinguish our ARCUS-based allogeneic CAR T development approach."
About PBCAR19B
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 reducing rejection by T cells and natural killer (NK) cells. In addition to the CAR gene, the stealth vector includes 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 MHC expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic T cells. The stealth vector also carries an HLA-E gene intended to reduce rejection of CAR T cells by NK cells that can be stimulated as a result of reduced MHC molecule expression on the cell surface. The U.S. Food and Drug Administration has accepted the Investigational New Drug application for PBCAR19B, and the Phase 1 clinical study is expected to begin by mid-2021.