Allogene Therapeutics to Present New Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Adult Patients with CD70 Positive Advanced Renal Cell Carcinoma (RCC) at the International Kidney Cancer Symposium (IKCS) and Society for Immunotherapy of Cancer (SITC) Annual Meeting
Allogene Therapeutics will present new data from its Phase 1 TRAVERSE trial for ALLO-316, an off-the-shelf AlloCAR T™ therapy targeting CD70-positive renal cell carcinoma (RCC), at the International Kidney Cancer Symposium and SITC Annual Meeting. The presentations will showcase data from 26 heavily pretreated patients and include details on managing treatment-associated hyperinflammatory responses.
The FDA granted RMAT designation to ALLO-316 in October 2024, recognizing its potential to address unmet needs in adult patients with advanced RCC who have failed standard therapies. The ongoing TRAVERSE trial demonstrates ALLO-316's ability to elicit responses from a single infusion, suggesting a breakthrough in allogeneic CAR T therapy for solid tumors.
Allogene Therapeutics presenterà nuovi dati dal suo trial di Fase 1 TRAVERSE per ALLO-316, una terapia AlloCAR T™ pronta all'uso che mira al carcinoma a cellule renali (RCC) positivo per CD70, durante il Simposio Internazionale sul Cancro Rena e l'Incontro Annuale SITC. Le presentazioni mostreranno dati provenienti da 26 pazienti fortemente pretrattati e includeranno dettagli sulla gestione delle risposte iperinfiammatorie associate al trattamento.
La FDA ha concesso la designazione RMAT ad ALLO-316 nell'ottobre 2024, riconoscendo il suo potenziale per soddisfare esigenze insoddisfatte in pazienti adulti con RCC avanzato che hanno fallito le terapie standard. Il trial TRAVERSE in corso dimostra la capacità di ALLO-316 di innescare risposte da un'unica infusione, suggerendo un progresso significativo nella terapia CAR T allogenica per i tumori solidi.
Allogene Therapeutics presentará nuevos datos de su ensayo de Fase 1 TRAVERSE para ALLO-316, una terapia AlloCAR T™ lista para usar que se dirige al carcinoma de células renales (RCC) positivo para CD70, en el Simposio Internacional de Cáncer Renal y la Reunión Anual de SITC. Las presentaciones mostrarán datos de 26 pacientes con un intenso tratamiento previo e incluirán detalles sobre el manejo de las respuestas hiperinflamatorias asociadas al tratamiento.
La FDA otorgó la designación RMAT a ALLO-316 en octubre de 2024, reconociendo su potencial para abordar necesidades insatisfechas en pacientes adultos con RCC avanzado que han fallado en las terapias estándar. El ensayo TRAVERSE en curso demuestra la capacidad de ALLO-316 para inducir respuestas a partir de una única infusión, lo que sugiere un avance en la terapia CAR T alogénica para tumores sólidos.
Allogene Therapeutics는 ALLO-316의 1상 TRAVERSE 시험에서 새로운 데이터를 발표할 예정입니다. ALLO-316은 CD70 양성 신장암(RCC)을 표적으로 하는 즉시 사용 가능한 AlloCAR T™ 치료제입니다. 발표는 26명의 강하게 치료를 받은 환자들로부터의 데이터를 보여주며, 치료 관련 과다 염증 반응 관리에 대한 세부정보를 포함합니다.
2024년 10월, FDA는 ALLO-316에 대해 RMAT 지정을 부여했으며, 이는 표준 치료에 실패한 진행성 RCC 성인 환자의 충족되지 않은 요구 사항을 해결할 가능성을 인식한 것입니다. 진행 중인 TRAVERSE 시험은 ALLO-316이 단일 주입으로 반응을 이끌어낼 수 있음을 보여주며, 고형 종양을 위한 동종 CAR T 치료법에서의 중대한 발전을 시사합니다.
Allogene Therapeutics présentera de nouvelles données de son essai de phase 1 TRAVERSE pour ALLO-316, une thérapie AlloCAR T™ prête à l'emploi ciblant le carcinome à cellules rénales (RCC) positif pour CD70, lors du Symposium International sur le Cancer Rénal et de la Réunion Annuelle de la SITC. Les présentations mettront en avant des données provenant de 26 patients fortement prétraités et incluront des détails sur la gestion des réponses hyperinflammatoires associées au traitement.
La FDA a accordé la désignation RMAT à ALLO-316 en octobre 2024, reconnaissant son potentiel à répondre aux besoins non satisfaits des patients adultes atteints de RCC avancé ayant échoué aux thérapies standards. L'essai TRAVERSE en cours démontre la capacité d'ALLO-316 à provoquer des réponses à partir d'une seule infusion, suggérant une avancée dans la thérapie CAR T allogénique pour les tumeurs solides.
Allogene Therapeutics wird neue Daten aus seiner Phase-1-Studie TRAVERSE für ALLO-316 präsentieren, einer sofort verfügbaren AlloCAR T™-Therapie, die auf CD70-positive Nierenzellkarzinome (RCC) abzielt, im Rahmen des Internationalen Symposiums für Nierenkrebs und der jährlichen SITC-Konferenz. Die Präsentationen werden Daten von 26 stark vorbehandelten Patienten zeigen und Details zum Umgang mit behandlungsassoziierten hyperinflammatorischen Reaktionen enthalten.
Die FDA hat ALLO-316 im Oktober 2024 den RMAT-Status verleihen und damit dessen Potenzial anerkannt, nicht erfüllte Bedürfnisse von erwachsenen Patienten mit fortgeschrittenem RCC, die auf Standardtherapien nicht angesprochen haben, zu adressieren. Die laufende TRAVERSE-Studie zeigt, dass ALLO-316 bei einer einzigen Infusion Reaktionen hervorrufen kann, was einen Durchbruch in der allogenen CAR-T-Therapie für solide Tumoren nahelegt.
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- ALLO-316, an “Off-the-Shelf” AlloCAR T™ Anti-CD70 CAR T Product, is Currently Under Investigation in the Phase 1 TRAVERSE Trial for Patients with Renal Cell Carcinoma (RCC) Previously Treated with Immune Checkpoint Inhibitors and VEGF-Targeting Therapies
- Data Presented Advances Scientific Understanding and Applicability of the Dagger® Technology as the Next-Generation Allogeneic Platform to Maximize the Potential of a Single Infusion, AlloCAR T Product
- Ongoing Phase 1 Data Supported the FDA's Recent RMAT Designation for ALLO-316 as a Promising Treatment to Address an Unmet Medical Need for Adults with Advanced or Metastatic CD70 Positive RCC Who Have Failed Standard RCC Therapies
SOUTH SAN FRANCISCO, Calif., Nov. 05, 2024 (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 new data from the ongoing Phase 1 TRAVERSE trial at the 2024 International Kidney Cancer Symposium (IKCS) and the Society for Immunotherapy of Cancer's (SITC) annual meeting. The trial evaluates ALLO-316, the Company’s first AlloCAR T product candidate for the potential treatment of solid tumors. These presentations will highlight data from 26 heavily pretreated patients with CD70 positive renal cell carcinoma (RCC) and will include details on the diagnostic and treatment algorithm used to mitigate treatment-associated hyperinflammatory response seen in some patients. The ongoing Phase 1 data supported the U.S. Food and Drug Administration’s (FDA) October 2024 decision to grant Regenerative Medicine Advanced Therapy (RMAT) designation for ALLO-316 based on clinical data from the TRAVERSE trial indicating its to address the unmet need for adult patients with advanced or metastatic CD70 positive RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy.
“We are looking forward to presenting the most recent Phase 1 data from our ongoing TRAVERSE trial at both SITC and IKCS,” said Zachary Roberts, M.D., Ph.D., EVP of Research & Development and Chief Medical Officer. “There is significant unmet need for these heavily pretreated patients with advanced RCC. In treating their disease, these patients rarely get any form of treatment break as their disease quickly progresses. This data highlights the potential of ALLO-316 to elicit a response from a single infusion, suggesting a breakthrough in allogeneic CAR T therapy for solid tumors. As the Phase 1 data matures, we plan to seek FDA’s input for the next stage of clinical development.”
2024 International Kidney Cancer Symposium (IKCS)
Title: TRAVERSE: Updated safety and efficacy of ALLO-316 in advanced/metastatic clear cell renal cell carcinoma (ccRCC)
Presenter: Ritesh Kotecha, M.D., Memorial Sloan Kettering Cancer Center
Session Date and Time: Friday, November 8, 11:50 a.m. ET
The Society for Immunotherapy of Cancer's (SITC) Annual Meeting
Title: ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC): Updated safety and efficacy from the phase 1 TRAVERSE multicenter study
Presenter: Samer Srour, M.D., The University of Texas MD Anderson Cancer Center
Abstract Number: 322
Date and Time: Saturday, November 9, 12:15-1:45 p.m. CT, 7:00-8:30 p.m. CT
The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic RCC. The development of ALLO-316 continues to advance the scientific understanding and applicability of the Dagger technology as the next-generation allogeneic platform with the ability to maximize the potential of a one-time infusion. In April 2024, the Company announced a
About ALLO-316 (TRAVERSE)
ALLO-316, an AlloCAR T™ investigational product, targets 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. ALLO-316 utilizes the Dagger® technology to optimize CAR T cell expansion and persistence to maximize the potential efficacy in solid tumors with a one-time infusion. 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 March 2022, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to ALLO-316, and in October 2024 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 based on its potential to address the unmet need for adult patients with CD70 positive advanced or metastatic RCC who have failed standard RCC therapies.
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 @AllogeneTx on X and LinkedIn.
About the California Institute for Regenerative Medicine (CIRM)
At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast-track the development of today’s most promising stem cell technologies. CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of regenerative medicine closer to reality.
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 “potential,” “continue,” “plans,” “will,” “advance,” “goal,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements are statements that are not historical facts, including statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the future development, timing, and success of clinical trials and product candidates; statements regarding the potential of ALLO-316 as a treatment for patients with advanced renal cell carcinoma (RCC); the advancement of Allogene’s Dagger® technology as a next-generation allogeneic platform; the anticipated benefits of a one-time infusion therapy; Allogene’s plans to seek additional FDA input for the clinical development of ALLO-316; and Allogene’s ability to deliver cell therapy on-demand, faster, 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 ongoing clinical trial for ALLO-316 and potential adverse effects; uncertainties regarding regulatory interactions, including future feedback from the U.S. Food and Drug Administration and implications of the RMAT designation; risks relating to the development of allogeneic cell therapy and CAR T products; the impact of competitive and market conditions; uncertainties relating to our novel technologies which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; difficulties we may encounter enrolling patients in our clinical trials; and uncertainties regarding our ability to obtain additional financing to develop our products and implement our operating plans. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factors” heading in its Form 10-Q filed for the quarter ended June 30, 2024, filed with the SEC on August 7, 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™ and Dagger® are trademarks of Allogene Therapeutics, Inc.
Allogene’s investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD70 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
EVP, Chief Corporate Affairs & Brand Strategy Officer
Christine.Cassiano@allogene.com
FAQ
What is the significance of ALLO-316's RMAT designation in October 2024?
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When and where will the new ALLO-316 trial data be presented?
What funding did Allogene receive for the ALLO-316 TRAVERSE trial?
