Kyverna Therapeutics Inc. has presented details on the development and preclinical characterization of KYV-102, an autologous fully human anti-CD19 CAR T-cell therapy developed for diseases driven by B cells, such as systemic lupus erythematosus (SLE), among others.
To address limitations with CAR T therapies targeting CD19, Allogene Therapeutics Inc. has developed ALLO-329, a CD19/CD70-targeting CAR therapy that is able to deplete activated alloreactive lymphocytes, while endowing dual targeting of CD19+ B cells and CD70+ T cells.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Poseida Therapeutics Inc. is being bought out for $1.5 billion by partner Roche Holdings Inc. to develop allogeneic CAR T therapies to treat hematologic malignancies. The two companies began their collaboration in August 2022, a deal that brought Poseida $110 million up front and another $110 million in near-term milestone payments. With the acquisition, Roche plans to develop CAR T programs for solid tumors and autoimmune diseases with Poseida's genetic engineering platform and preclinical programs.
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
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