• Research Provides Early Validation of ALLO-182, an AlloCAR T™ Candidate in the IND-Enabling Phase of Development Targeting Claudin18.2 for the Treatment of Patients with Gastric and Pancreatic Cancers

SOUTH SAN FRANCISCO, Calif., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today presented 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) Annual Meeting November 1-5, 2023, in San Diego, CA.

Data presented at SITC 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.

About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.

Cautionary Note on Forward-Looking Statements for Allogene
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “advance,” "predicts," "believes," “suggests,” "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things Allogene’s ability to develop and deliver readily available allogeneic CAR T products for cancer treatment on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene’s expectations and actual results, including risks and uncertainties related to: our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the extent to which the FDA disagrees with our clinical or regulatory plans, which could cause delays to our IND approval and future clinical trials or require additional clinical trials; and we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factor” Heading in its Form 10-Q filed for the quarter ended September 30, 2023. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

Allogene’s AlloCAR T™ programs utilize Cellectis technologies. The Claudin18.2 AlloCAR T program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this AlloCAR T program.

Allogene Media/Investor Contact:
Christine Cassiano
Chief Corporate Affairs & Brand Strategy Officer
Christine.Cassiano@allogene.com

Additional Allogene Media Contacts:
Leslie Bryant
Leslie.Bryant@allogene.com

Madeleine Goldstein
Madeleine.Goldstein@allogene.com