Allogene Therapeutics Announces ASCO 2025 Abstract Publication Featuring Oral Presentation of ALLO-316 in Kidney Cancer and ALPHA3 TIP Poster for Cema-Cel
Allogene Therapeutics (NASDAQ: ALLO) announced two key presentations at the upcoming 2025 ASCO Annual Meeting. The first is an oral presentation featuring ALLO-316, their investigational AlloCAR T product targeting CD70 for advanced renal cell carcinoma (RCC). ALLO-316, utilizing the proprietary Dagger® technology, is notable as the first allogeneic CAR T product showing promise in solid tumors. The presentation will include updated data from the Phase 1 TRAVERSE study's expansion cohort.
Additionally, a Trial-in-Progress poster will showcase the Phase 2 ALPHA3 trial design for cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL). This trial evaluates cema-cel as a first-line consolidation treatment for patients who remain minimal residual disease (MRD) positive after initial chemoimmunotherapy.
Allogene Therapeutics (NASDAQ: ALLO) ha annunciato due presentazioni principali al prossimo ASCO Annual Meeting 2025. La prima sarà una presentazione orale dedicata a ALLO-316, il loro prodotto AlloCAR T sperimentale che mira al CD70 per il carcinoma renale avanzato (RCC). ALLO-316, che utilizza la tecnologia proprietaria Dagger®, è il primo prodotto CAR T allogenico a mostrare risultati promettenti nei tumori solidi. La presentazione includerà dati aggiornati dalla coorte di espansione dello studio di Fase 1 TRAVERSE.
Inoltre, un poster Trial-in-Progress presenterà il disegno dello studio di Fase 2 ALPHA3 per cemacabtagene ansegedleucel (cema-cel) nel linfoma a grandi cellule B (LBCL). Questo studio valuta cema-cel come trattamento di consolidamento di prima linea per pazienti con malattia residua minima (MRD) positiva dopo la chemioterapia immunoterapica iniziale.
Allogene Therapeutics (NASDAQ: ALLO) anunció dos presentaciones clave en la próxima Reunión Anual ASCO 2025. La primera será una presentación oral sobre ALLO-316, su producto AlloCAR T en investigación dirigido al CD70 para carcinoma renal avanzado (RCC). ALLO-316, que utiliza la tecnología patentada Dagger®, es el primer producto CAR T alogénico que muestra resultados prometedores en tumores sólidos. La presentación incluirá datos actualizados de la cohorte de expansión del estudio de Fase 1 TRAVERSE.
Además, un póster Trial-in-Progress mostrará el diseño del ensayo de Fase 2 ALPHA3 para cemacabtagene ansegedleucel (cema-cel) en linfoma de células B grandes (LBCL). Este ensayo evalúa cema-cel como tratamiento de consolidación de primera línea para pacientes que permanecen positivos a enfermedad residual mínima (MRD) tras la quimioinmunoterapia inicial.
Allogene Therapeutics (NASDAQ: ALLO)는 다가오는 2025 ASCO 연례회의에서 두 가지 주요 발표를 예고했습니다. 첫 번째는 진행성 신세포암(RCC)을 표적으로 하는 연구 중인 AlloCAR T 제품 ALLO-316에 관한 구두 발표입니다. ALLO-316는 독점 기술인 Dagger®를 활용한 고형암에서 가능성을 보인 최초의 동종 CAR T 제품으로 주목받고 있습니다. 발표에는 1상 TRAVERSE 연구 확장 코호트의 최신 데이터가 포함됩니다.
또한, 진행 중인 임상시험 포스터에서는 대형 B세포 림프종(LBCL)을 대상으로 한 2상 ALPHA3 시험 설계가 소개됩니다. 이 시험은 초기 화학면역요법 후 최소 잔존 질환(MRD) 양성 환자를 위한 1차 통합 치료로서 cemacabtagene ansegedleucel (cema-cel)을 평가합니다.
Allogene Therapeutics (NASDAQ : ALLO) a annoncé deux présentations clés lors du prochain congrès annuel ASCO 2025. La première est une présentation orale portant sur ALLO-316, leur produit AlloCAR T expérimental ciblant CD70 pour le carcinome rénal avancé (RCC). ALLO-316, utilisant la technologie propriétaire Dagger®, est notable en tant que premier produit CAR T allogénique montrant un potentiel dans les tumeurs solides. La présentation comprendra des données actualisées de la cohorte d'expansion de l'étude de phase 1 TRAVERSE.
De plus, un poster Trial-in-Progress présentera le design de l'essai de phase 2 ALPHA3 pour cemacabtagene ansegedleucel (cema-cel) dans le lymphome B à grandes cellules (LBCL). Cet essai évalue cema-cel comme traitement de consolidation de première ligne chez les patients restant positifs pour une maladie résiduelle minimale (MRD) après une chimiothérapie immunitaire initiale.
Allogene Therapeutics (NASDAQ: ALLO) kündigte zwei wichtige Präsentationen auf dem bevorstehenden ASCO-Jahrestreffen 2025 an. Die erste ist eine mündliche Präsentation über ALLO-316, ihr untersuchtes AlloCAR T-Produkt, das CD70 bei fortgeschrittenem Nierenzellkarzinom (RCC) anvisiert. ALLO-316, das die proprietäre Dagger®-Technologie nutzt, ist bemerkenswert als das erste allogene CAR T-Produkt, das bei soliden Tumoren vielversprechende Ergebnisse zeigt. Die Präsentation wird aktualisierte Daten aus der Erweiterungskohorte der Phase-1-Studie TRAVERSE enthalten.
Zusätzlich wird ein Trial-in-Progress-Poster das Design der Phase-2-Studie ALPHA3 für cemacabtagene ansegedleucel (cema-cel) bei großzelligem B-Zell-Lymphom (LBCL) vorstellen. Diese Studie bewertet cema-cel als Erstlinien-Konsolidierungsbehandlung für Patienten, die nach der initialen Chemoimmuntherapie minimalen Resterkrankungsstatus (MRD) aufweisen.
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Insights
Allogene advances first promising allogeneic CAR T for solid tumors with ALLO-316 data presentation and progresses cema-cel pivotal trial for lymphoma.
Allogene's upcoming ASCO presentations mark significant milestones in their allogeneic CAR T pipeline. The oral presentation of ALLO-316 data is particularly noteworthy as it represents the first allogeneic CAR T therapy showing promise in solid tumors - historically an extremely challenging frontier in cellular therapy. This CD70-targeting therapy for renal cell carcinoma incorporates their proprietary Dagger® technology to enhance CAR T expansion, addressing a critical limitation of previous allogeneic approaches.
The presentation will focus on updated data from the Phase 1 TRAVERSE study, specifically the Phase 1b expansion cohort using a standardized lymphodepletion regimen of cyclophosphamide/fludarabine followed by 80 million CAR T cells. This standardization suggests the company has identified what they believe is an optimal treatment protocol.
Additionally, the Trial-in-Progress poster for
These presentations reflect Allogene's dual-pronged strategy: breakthrough innovation in solid tumors while advancing more established hematological applications toward commercialization. The selection of an oral presentation format for ALLO-316 by ASCO's scientific committee suggests recognition of the data's significance within the oncology community.
SOUTH SAN FRANCISCO, Calif., May 22, 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 the publication of two abstracts on the American Society of Clinical Oncology (ASCO) website in advance of the 2025 ASCO Annual Meeting, taking place May 30-June 3 in Chicago, Illinois.
An oral presentation will feature ALLO-316, an investigational AlloCAR T product targeting CD70. ALLO-316 is currently being studied in patients with advanced or metastatic renal cell carcinoma (RCC). Leveraging the proprietary Dagger® technology to enable robust CAR T cell expansion, it stands as the first and only allogeneic CAR T product to show promise in treating solid tumors. The upcoming presentation will share updated data from the Phase 1 TRAVERSE study with a focus on the Phase 1b expansion cohort in which patients were treated with a standard regimen of cyclophosphamide and fludarabine followed by a single dose of 80 million CAR T cells.
In addition, a Trial-in-Progress (TIP) poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (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.
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 Center
Session Title: Oral Abstract Session – Genitourinary Cancer – Kidney and Bladder
Abstract: #4508
Location: Hall D2
Session Date and Time: Sunday, June 1, 9:45AM-12:45PM CT
Presentation Time: 12:21 PM-12:33 PM CT
ALPHA3: A pivotal phase 2 study of first line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients 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 Center
Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Abstract: TPS7085
Poster Board: #267a
Location: Hall A
Poster 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 an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.
About the ALPHA3 Trial
Over 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
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 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 Allogene
This 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,” “expect,” “can,” “see if,” “positioning,” “become,” “may,” “could,” “designed to,” 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 cema-cel to be part of a first-line consolidation strategy in patients with large B-cell lymphoma (LBCL) and minimal residual disease (MRD); the potential for cema-cel to become the standard “7th cycle” of frontline treatment; 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; 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-Q for the year ended March 31, 2025. 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 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 Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
(714) 552-0326
Christine.Cassiano@allogene.com
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