CD70

RMAT Designation Follows Positive Proof-of-Concept Data from the ALLO-316 TRAVERSE Trial in Adult Patients with Advanced or Metastatic CD70 Positive Renal Cell Carcinoma (RCC) Who Received Prior Immune Checkpoint Inhibitor and VEGF-Targeting Therapy ALLO-316 Advances Scientific Understanding and Applicability of the Dagger® Technology as the Next-Generation Allogeneic Platform to Maximize the Potential of a Single Infusion of an “Off-the-Shelf” CAR T Product Company to Present Updated Phase 1 Data from the TRAVERSE Trial at the Society for Immunotherapy of Cancer (SITC) Annual Meeting ALLO-316 was Previously Granted Fast Track Designation (FTD) in March 2022 by the U.S. Food and Drug Administration Oct. 29, 2024 -- 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 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for the treatment of adult patients with CD70 positive advanced or metastatic renal cell carcinoma (RCC). The RMAT designation was based on clinical data from the TRAVERSE trial indicating the potential of ALLO-316 to address the unmet need for patients with difficult-to-treat RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy. The ongoing development of ALLO-316 continues to advance the scientific understanding and applicability of the Dagger® technology as the next-generation allogeneic platform to maximize the potential of a single infusion of “off-the-shelf” CAR T product in solid tumors. “The RMAT designation for ALLO-316 highlights the transformative potential of our AlloCAR T™ platform to offer new hope for heavily pretreated patients with renal cell carcinoma who have exhausted standard treatment options,” said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer. “This important milestone moves us closer to fulfilling the promise of “off-the-shelf” CAR T therapy—delivering faster, more reliable, and widely accessible treatments. We remain optimistic about the future of ALLO-316 and its potential to be an important advancement for patients.” 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. Initial results from the TRAVERSE trial were presented in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida, in 2023. The Company will present updated Phase 1 data from the TRAVERSE trial at the Society for Immunotherapy of Cancer (SITC) annual meeting. The RMAT designation is intended to accelerate the development and review of promising investigational products, including cell therapies. To qualify, a product must be designed to treat, modify, reverse, or cure a serious or life-threatening disease, with preliminary clinical evidence suggesting it can address unmet medical needs. The RMAT designation offers several key advantages, including early and frequent interactions with the FDA to discuss potential surrogate or intermediate endpoints, as well as strategies to meet post-approval requirements, potentially streamlining the path to market approval. 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. 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. 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REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced acceptance of an oral presentation at the upcoming American Society of Gene & Cell Therapy’s (ASGCT) 2024 Advancing Gene and Cell Therapies for Cancer conference, taking place October 16 – 17, 2024, in Philadelphia, PA. Details of the oral presentation are as follows: Title: ADI-270: An Armored Allogeneic Anti-CD70 CAR γδ T cell Therapy Designed for Enhanced Potency and Persistence Against Multiple Oncology Indications Session Name: Novel Targets and Effector Cells Abstract Number: 8 Presenting Author: Shon Green, Ph.D. Date and Time: October 17, 2024; 11:15 a.m. – 11:30 a.m. ET About Adicet Bio, Inc. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at . Contacts Adicet Bio, Inc. Investors: Anne Bowdidge abowdidge@adicetbio.com Janhavi Mohite Precision AQ 212-362-1200 janhavi.mohite@precisionaq.com Media: Kerry Beth Daly kbdaly@adicetbio.com

The CD19/CD70 Dual CAR is Specifically Designed to Address Both the B-cell and T-cell Dysfunction Implicated in Autoimmune Diseases ALLO-329, is an Investigational Product Built on a New Gene Editing Platform that Features Site-Specific Integration, Intended to Reduce the Risk of Secondary Malignancies, and Leverage the Clinically Validated Dagger® Effect Aimed at Reducing or Eliminating Lymphodepletion, a Potential Barrier in the Adoption of CAR T in Autoimmune Indications Sept. 26, 2024 -- 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 pre-clinical data for its next-generation investigational AlloCAR T candidate for autoimmune indications, ALLO-329, at the American College of Rheumatology's annual meeting, ACR Convergence 2024, being held from November 14-19 in Washington, D.C. ALLO-329, the Company’s CD19/CD70 dual AlloCAR T product is the first CAR T designed to both reduce or eliminate the need for lymphodepletion while also targeting CD19+ B-cells and CD70+ activated T-cells, both of which are likely to play a role in autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. “We are at the beginning of understanding what may be possible for CAR T in autoimmune disease. However, the only way to fully realize the potential of the modality is to develop product candidates designed to meet the specific needs of this vast patient population and allow for greater implementation in real-world practice. This is how we have designed ALLO-329,” said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development of Allogene. “We believe the first and most important factor for the potential success of CAR T in autoimmune disease is being available off-the-shelf to meet potential demand. Next, we have addressed lymphodepletion by incorporating our proprietary and clinically validated Dagger® technology, which is designed to enable cells to expand and persist in patients without or with potentially reduced chemotherapy conditioning. Lastly, our dual CAR targets both the B- and T-cell components of autoimmune disease, which we believe may allow for a broader application of CAR T across a multitude of indications.” Title: Preclinical Evaluation of ALLO-329: Allogeneic CD19 CAR T Cells Expressing an Anti-Rejection CD70 CAR for the Treatment of Autoimmune Diseases Presenter: Kristen Zhang, Research Scientist, Allogene Therapeutics Abstract Number: 1841 Poster Session: T Cell Biology & Targets in Autoimmune & Inflammatory Disease Poster Date and Time: Monday, November 18, 10:30 a.m-12:30 p.m. ET The abstract can be found on the American College of Rheumatology’s website. The Company plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration in the first quarter of 2025 and expects to have proof-of-concept by year-end 2025. 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 (formerly Twitter) and LinkedIn. The content above comes from the network. if any infringement, please contact us to modify.