SOUTH SAN FRANCISCO, Calif., April 23, 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 it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois. The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following immune checkpoint inhibitor and VEGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL). ALLO-316 is an allogeneic, “off-the-shelf” CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. Enrollment is now complete in the Phase 1b expansion cohort, which evaluated the safety and efficacy of ALLO-316 at dose level 2 (80M CAR T cells) following a standard lymphodepletion regimen of cyclophosphamide and fludarabine. The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy aimed at eradicating minimal residual disease (MRD) following 1L treatment in LBCL. It is assessing cema-cel in patients with MRD after standard 1L chemoimmunotherapy, such as R-CHOP, with the goal of improving 1L cure rates. The trial identifies patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY™, powered by PhasED-Seq™, a novel Investigational Use Only (IUO) test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). Allogene Presentations at the 2025 ASCO Annual Meeting: ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study.Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer CenterSession Title: Oral Abstract Session – Genitourinary Cancer – Kidney and BladderAbstract: #4508Location: Hall D2Presentation Date and Time: Sunday, June 1, 9:45AM – 12:45PM CT ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy. Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson Cancer CenterSession Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic LeukemiaAbstract: TPS7085Poster Board: #267a Location: Hall APoster Session Display Date and Time: Sunday, June 1, 9:00AM – 12:00PM CT 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 ALLO-316 (TRAVERSE)ALLO-316 is an AlloCAR T™ investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced a $15 million award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.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. This press release may, in some cases, use terms such as “develop,” “potential,” “encouraging,” “expect,” “can,” “see if,” “positioning,” “become,” “may,” “could,” “designed to,” “aim,” or “will,” including alternative forms thereof, 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 potential for the ALPHA3 trial and an investigational minimal residual disease test to identify patients with LBCL who are at high risk for relapse after 1L treatment; the potential for cema-cel to become the standard “7th cycle” of frontline treatment; the potential for cema-cel to eradicate MRD or demonstrate a meaningful improvement in event free survival in patients treated with cema-cel relative to patients who receive current standard of care; that cema-cel can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy; the timing for completion of ALPHA3 enrollment or cema-cel BLA submission; the incidence of LBCL including the extent to which patients will relapse and require subsequent treatment; the potential for our product candidates to be approved; the potential benefits of the ALPHA3 trial and of AlloCAR T™ products; cema-cel’s safety profile; the potential of ALLO-316 as a treatment for patients with advanced or metastatic CD70+ RCC; the potential for ALLO-316 and CAR T-cell therapy to treat hematologic malignancies and solid tumors; our ability to deliver cell therapy 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: the limited nature of our Phase 1 data from our clinical trials and the extent to which such data may or may not be validated in any future clinical trials; 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 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 challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation under the “Risk Factors” heading in its Quarterly Report on Form 10-K for the year ended December 31, 2024. 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.CLARITY™ and PhasED-Seq™ are trademarks of Foresight Diagnostics. Allogene’s investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD19 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
