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.
Gene editing strategies, from epigenetic engineering to cell reprogramming and genetic vaccines, are accelerating the development of new therapies that awaken the immune system to treat cancer, as presented last month in Rome at the 31st Annual Congress of the European Society of Gene and Cell Therapy (ESGCT). Some of these advances are taking advantage of the conditions of the tumor microenvironment, where cancer cells coexist with immune cells, microorganisms and blood vessels.
Although details are scant, Shanghai Fosun Pharmaceutical Co. Ltd. plans to buy out partner Kite Pharma Inc. (now Gilead Sciences Inc.) in the Fosun Pharma Kite Biotechnology Co. Ltd. joint venture for $27 million.
Although details are scant, Shanghai Fosun Pharmaceutical Co. Ltd. plans to buy out partner Kite Pharma Inc. (now Gilead Sciences Inc.) in the Fosun Pharma Kite Biotechnology Co. Ltd. joint venture for $27 million.
Researchers from Oricell Therapeutics (Shanghai) Co. Ltd. presented the discovery and preclinical characterization of ORIC-613, a dual-targeting CAR T-cell therapy being developed for the treatment of pancreatic and gastric cancer.
A patient death and cases of pneumonitis overshadowed positive signs of efficacy for South San Francisco-based Lyell Immunopharma Inc.’s ROR1 CAR T-cell candidate, LYL-797, which is treating triple-negative breast cancer and non-small-cell lung cancer in a phase I trial.
CAR T-cell therapy that targets BCMA is an effective option for treating relapsed/refractory multiple myeloma, but there is a lack of persistence due to the inability to develop a memory phenotype.
Despite what University of Pennsylvania (Penn) immunotherapy pioneer Carl June referred to as a “cold slap last November” – a launched investigation by the U.S. FDA into a possible link between CAR T-cell immunotherapies and secondary cancers – new unpublished studies by Penn and Stanford University highlight the rarity of such cases.
Flindr Therapeutics BV has raised €20 million (US$21.4 million) in a series A round to advance small-molecule immune modulators aimed at targets it has identified in cancer patients who respond to existing immunotherapies.
Following the U.S. FDA’s expansion of competing BCMA-targeting CAR T therapy Abecma (idecabtagene vicleucel) to include third-line and later treatment in multiple myeloma (MM) patients, the agency cleared Carvykti (ciltacabtagene autoleucel) from Legend Biotech Corp. and Johnson & Johnson’s Janssen unit for use in MM patients as early as second-line treatment. The label, which RBC Capital Markets analyst Leonid Timashev called a “best-case scenario,” includes no notable updates to the black box warning and should help accelerate and expand Carvykti’s update in the U.S., with 2024 revenues expected to top $950 million.
