The LA-based leading cell therapy company, Kite Pharma, said it has submitted to the FDA an Investigational New Drug (IND) application to launch a Phase I, first-in-human trial of a chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) in patients with relapsed/refractory multiple myeloma.
The pharma had intended to advance KITE-585 into the clinic back in April, when it presented preclinical data on the CAR-T therapy at the American Association of Cancer Research (AACR) Annual Meeting in Washington D.C.
The candidate contains a receptor derived from a fully human monoclonal antibody and a CD28 co-stimulatory domain intended for optimized T-cell expansion and function. KITE-585 is designed to work through the engineering of a patient’s T cells to express a CAR that targets BCMA, then redirecting those T cells to kill cancer cells.
“KITE-585 has the potential to become Kite’s next significant advance in cell therapy for patients with cancer,” David Chang, M.D., Ph.D., Kite’s evp of R&D and CMO, said in a statement.
KITE-585 is Kite’s third CAR-T cancer immunotherapy candidate to advance into the clinic and beyond. The company in March completed its Biologics License Application seeking FDA approval for its lead CAR-T product axicabtagene ciloleucel (formerly
Last month, Kite submitted the first CAR-T application in Europe, a marketing authorization application to the European Medicines Agency seeking approval of axicabtagene ciloleucel for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for ASCT.
Kite and Novartis have emerged as leading developers of CAR-T cancer immunotherapies. While Novartis is ahead of Kite in the US in the race to get a CAR-T therapy to market, with an FDA decision due in the coming weeks, Kite has taken the lead in Europe by filing its rival with the European Medicines Agency first.
