NEW YORK – Bellicum Pharmaceuticals said on Monday that the US Food and Drug Administration has accepted its investigational new drug application for its CAR T cell therapy, BPX-603, allowing it to proceed with human clinical trials.
Bellicum plans to initiate a Phase I/II trial of BPX-603 in patients with HER2-positive solid tumors later this year.
BPX-603 is one of Bellicum's GoCAR T product candidates and includes HER2-targeted CAR-T cells that can override key immune inhibitory mechanisms, such as a suppressive tumor microenvironment, in order to stimulate the patient's own immune system to go after cancer cells. It has a dual switch design that includes an inducible co-activation domain MyD88/CD40 and the company's CaspaCIDe safety switch.
The safety switch design can allow clinicians to activate or eliminate GoCAR T cells by administering small molecules to the patient. Researchers at Memorial Sloan Kettering and elsewhere are also exploring such safety switch mechanisms as a way to limit toxicities of CAR T cell therapies while boosting efficacy in solid tumors.