Allogene Therapeutics Presents Preclinical Data on a Novel Allogeneic CAR T Product Candidate Targeting Claudin18.2 at the Society for Immunotherapy of Cancer Annual Meeting

On November 3, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported preclinical data on a novel off-the-shelf AlloCAR T product candidate targeting Claudin18.2 (CLDN18.2)-positive gastric and pancreatic tumors, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting November 1-5, 2023, in San Diego, CA (Press release, Allogene, NOV 3, 2023, View Source [SID1234636876]).

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Data presented at SITC (Free SITC Whitepaper) describes preclinical development of Allogene’s novel allogeneic CLDN18.2 CAR T product candidate with the potential to provide clinical benefit to patients with a single, off-the-shelf infusion. CLDN18.2 has emerged as a promising therapeutic target, with high expression in many types of epithelial tumors including gastric, esophageal, pancreatic and ovarian cancers.

"Proof of concept for a CAR T targeting Claudin18.2 has been established, but limitations of autologous therapies, including the need for leukapheresis, long manufacturing wait times in patients with recent chemotherapy exposure, and high tumor and comorbidity burdens, would likely restrict availability to patients," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "An allogeneic product, derived from healthy donors and readily available to patients at the time of progression has the potential to overcome such challenges. We believe these preclinical data support a pathway to targeting CLDN18.2-positive solid tumors with an AlloCAR T product. This preclinical research further elucidates the depth of opportunity for our solid tumor program, and the potential to bring one of the most exciting modalities in modern times to patients in need."

The preclinical evaluation identified candidates with potent activity in both short-term and repeat stimulation in vitro cytotoxicity assays. The lead IND candidates researched displayed robust antitumor activity at low cell doses in vivo against both subcutaneous and intraperitoneal gastric cancer models. Data suggest the existence of a therapeutic window and the potential to target CLDN18.2 with allogeneic off-the-shelf CAR T cells without significant off tumor toxicity. These data were the foundation for ALLO-182, currently in the IND-enabling phase of development. ALLO-182 together with ALLO-213, an allogeneic CAR T targeting DLL3, represent the company’s early-stage solid tumor product candidates.