Allogene Therapeutics Announces ALPHA3 Trial-in-Progress Poster Presentation at ASH Annual Meeting

November 03, 2025 09:04 ET | Source: Allogene Therapeutics, Inc. SOUTH SAN FRANCISCO, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that a Trial-in-Progress (TIP) poster highlighting the pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) will be presented at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. ALPHA3 is a randomized study with two arms, comparing cema-cel administered following standard FC lymphodepletion versus observation, the current standard of care. The poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cema-cel as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy. Cema-cel is an investigational, next-generation anti-CD19 AlloCAR T product designed to provide an “off-the-shelf” cell therapy option that can be administered immediately upon the detection of MRD. With its focus on this rapidly emerging area in oncology, the ALPHA3 trial positions Allogene at the forefront of a transformative shift toward earlier and more precise treatment. A futility analysis comparing MRD conversion between the two arms is expected to occur 1H 2026. Poster Presentation Details: ALPHA3: First-line consolidation with cemacabtagene ansegedleucel (cema-cel) in patients with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy: the pivotal, randomized, open-label phase 2 ALPHA3 study Presenter: John Burke, MD, Blood Cancer Specialist, Rocky Mountain Cancer CentersPublication Number: 3730Location: West Halls B3-B4: Orange County Convention Center (OCCC), Orlando, FLSession Name: 628. Aggressive Lymphomas: Cellular Therapies: Poster IIPoster Session Display Date and Time: Sunday, December 7, 6:00PM-8:00PM ET About Cemacabtagene Ansegedleucel (cema-cel)Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T™ investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.About the ALPHA3 TrialOver 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to “watch and wait” to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, “off-the-shelf” treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD. About Allogene TherapeuticsAllogene 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 and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell 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 Allogene Therapeutics on X and LinkedIn. Cautionary Note on Forward-Looking Statements for AllogeneThis 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 “indicates,” “deem,” “expected,” “next,” “potential,” “transform,” “believe,” “will,” “to see,” “scheduled,” “reduce,” “advancing,” “may,” “could,” “designed to,” “comparing,” “can,” “accelerate,” 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: ALPHA3 being a pivotal trial and the extent to which it will support regulatory approval of cema-cel; the Company’s clinical strategy; the potential for cema-cel to be a one-time off-the-shelf treatment or become the standard “7th cycle” of frontline treatment; that cema-cel can be administered immediately upon discovery of MRD; the timing the futility analysis; the potential for our product candidates to be approved; the potential benefits of the ALPHA3 trial and of AlloCAR T™ products; and other statements related to future events or conditions. 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 limited nature of our pre-clinical, and Phase 1 and Phase 2 data and the extent to which such data may or may not be validated in any future clinical trial; our product candidates in the past have and may in the future cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials, including initiation of clinical trials, or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; 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; and the challenges with manufacturing or optimizing manufacturing of our product candidates. Additional factors that could cause actual results to differ materially from those stated or implied by the Company’s forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission (SEC), including in the section captioned “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. These forward-looking statements represent the Company’s judgment as of the time of this press release. The Company disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law. AlloCAR T™ is a trademark of Allogene Therapeutics, Inc. Allogene’s investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD19 oncology products are developed based on an exclusive license granted by Cellectis to Servier. Servier, which has an exclusive license to the anti-CD19 AlloCAR T investigational products from Cellectis, has granted Allogene exclusive rights to these products in the U.S., all EU Member States and the United Kingdom. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy Officer(714) 552-0326Christine.Cassiano@allogene.com

Allogene Therapeutics Announces ALPHA3 Trial-in-Progress Poster Presentation at ASH Annual Meeting

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