- Dual-Targeted CD19/CD70 Allogeneic CAR T: Best-in-Class Design to Enhance Therapeutic Benefit and Expand Treatment Potential Across a Range of Autoimmune Disease Indications
- Innovative Dagger® Technology: Empowers ALLO-329 to Overcome Rejection, Potentially Reducing or Eliminating Reliance on Traditional Lymphodepletion
- Phase 1 RESOLUTION Rheumatology Basket Trial: Initiation Planned for Mid-2025, Targeting Proof-of-Concept to Demonstrate Allogeneic Potential and the Dagger® Effect on Lymphodepletion by Year-End 2025
SOUTH SAN FRANCISCO, CA, USA I January 28, 2025 I 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) has cleared its Investigational New Drug (IND) application for a rheumatology basket study of ALLO-329, an investigational allogeneic CAR T product.
The Phase 1 RESOLUTION basket trial will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. This innovative trial design, which leverages the clinically validated Dagger® technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone which is used by rheumatologists, and another that eliminates lymphodepletion entirely. The RESOLUTION trial is scheduled to begin in mid-2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases.
“A year ago, we unveiled the concept of ALLO-329, an allogeneic CAR T product specifically designed to address the unique challenges faced by patients with autoimmune diseases. Today, with the FDA’s clearance of our IND, that vision has become a reality, achieved at an extraordinary pace thanks to Allogene’s unparalleled expertise in research, manufacturing, and clinical development,” said David Chang, M.D., Ph.D., President, CEO, and Co-Founder of Allogene. “Demonstrating the power of an allogeneic CAR T to reset the immune system, combined with the ability of our Dagger® technology to reduce or eliminate lymphodepletion, could represent a transformative step forward. Successful proof-of-concept in this basket study has the potential to not only validate our best-in-class approach but also paves the way for expanding into a broad range of autoimmune indications beyond rheumatology.”
ALLO-329 represents a next-generation approach to autoimmune therapy, featuring a dual-targeting design against CD19+ B-cells and CD70+ activated T-cells. This innovative strategy is designed to deliver superior therapeutic benefit by addressing both B-cell and T-cell dysfunction, which drive immune dysregulation in autoimmune diseases. The incorporation of Allogene’s proprietary Dagger® technology further empowers ALLO-329 to resist immune rejection, potentially reducing or eliminating the need for lymphodepletion before cell infusion. If successful, this CAR T advancement could significantly simplify treatment protocols, meet the potential scale required to treat autoimmune disease with the capacity to manufacture upwards of 60,000 doses per year, and expand access to transformative CAR T therapy across a wide range of autoimmune disease indications.
About ALLO-329
ALLO-329 is a CD19/CD70 dual AlloCAR T™ investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene’s clinically validated Dagger® technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications.
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.
SOURCE: Allogene Therapeutics
Post Views: 392
- Dual-Targeted CD19/CD70 Allogeneic CAR T: Best-in-Class Design to Enhance Therapeutic Benefit and Expand Treatment Potential Across a Range of Autoimmune Disease Indications
- Innovative Dagger® Technology: Empowers ALLO-329 to Overcome Rejection, Potentially Reducing or Eliminating Reliance on Traditional Lymphodepletion
- Phase 1 RESOLUTION Rheumatology Basket Trial: Initiation Planned for Mid-2025, Targeting Proof-of-Concept to Demonstrate Allogeneic Potential and the Dagger® Effect on Lymphodepletion by Year-End 2025
SOUTH SAN FRANCISCO, CA, USA I January 28, 2025 I 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) has cleared its Investigational New Drug (IND) application for a rheumatology basket study of ALLO-329, an investigational allogeneic CAR T product.
The Phase 1 RESOLUTION basket trial will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. This innovative trial design, which leverages the clinically validated Dagger® technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone which is used by rheumatologists, and another that eliminates lymphodepletion entirely. The RESOLUTION trial is scheduled to begin in mid-2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases.
“A year ago, we unveiled the concept of ALLO-329, an allogeneic CAR T product specifically designed to address the unique challenges faced by patients with autoimmune diseases. Today, with the FDA’s clearance of our IND, that vision has become a reality, achieved at an extraordinary pace thanks to Allogene’s unparalleled expertise in research, manufacturing, and clinical development,” said David Chang, M.D., Ph.D., President, CEO, and Co-Founder of Allogene. “Demonstrating the power of an allogeneic CAR T to reset the immune system, combined with the ability of our Dagger® technology to reduce or eliminate lymphodepletion, could represent a transformative step forward. Successful proof-of-concept in this basket study has the potential to not only validate our best-in-class approach but also paves the way for expanding into a broad range of autoimmune indications beyond rheumatology.”
ALLO-329 represents a next-generation approach to autoimmune therapy, featuring a dual-targeting design against CD19+ B-cells and CD70+ activated T-cells. This innovative strategy is designed to deliver superior therapeutic benefit by addressing both B-cell and T-cell dysfunction, which drive immune dysregulation in autoimmune diseases. The incorporation of Allogene’s proprietary Dagger® technology further empowers ALLO-329 to resist immune rejection, potentially reducing or eliminating the need for lymphodepletion before cell infusion. If successful, this CAR T advancement could significantly simplify treatment protocols, meet the potential scale required to treat autoimmune disease with the capacity to manufacture upwards of 60,000 doses per year, and expand access to transformative CAR T therapy across a wide range of autoimmune disease indications.
About ALLO-329
ALLO-329 is a CD19/CD70 dual AlloCAR T™ investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene’s clinically validated Dagger® technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications.
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.
SOURCE: Allogene Therapeutics
Post Views: 392
