CAR-T Therapy targets B-cell maturation antigens in patients with multiple myeloma. 

Kite Pharma, Inc.’s development of CAR-T based personalized cancer treatments continues with the company’s release that it has submitted an Investigational New Drug (IND) application with the FDA to initiate the first-in-human trial of KITE-585. KITE-585 is its CAR-T-based cell therapy designed to identify B-cell maturation antigens (BCMA) in patients suffering relapsed or refractory multiple myeloma.

Expressed on the surface of malignant plasma cells, BCMA is present in most multiple myeloma patients, said Kite. According to the company, even though BCMA is found on normal plasma cells and mature B-cell lineage cells, it is not usually found on other tissues—and because it has demonstrated its role in the survival and growth of myeloma cells, the marker is an attractive CAR-T target.

"KITE-585 has the potential to become Kite's next significant advance in cell therapy for patients with cancer,” said David Chang, EVP of Research and Development and Kite’s Chief Medical Officer. Chang explained that the KITE-585 IND was the result of an extensive preclinical development effort that included candidate screening, engineering, and testing as well as company experience in CAR design and cellular therapeutics. "As we look ahead, we are confident that the cutting-edge design and manufacturing process of KITE-585 together with our proven capability with engineered T cells will support rapid execution of the clinical program," he commented.

According to the company, in 2017, an estimated 30,280 new cases of multiple myeloma will be diagnosed in the US, resulting in some 12,590 deaths. Kite explained KITE-585 contains a fully human monoclonal antibody receptor derived from a CD28 costimulatory domain, which is intended for optimized T-cell expansion and function. Advanced processes and materials used in the manufacturing of KITE-585, said the company, are designed to achieve enhanced cell potency. According to Kite, in preclinical studies, KITE-585 therapy was active across “a range of low and high BCMA expressing targets and its activity was not impaired by soluble BCMA."