Bellicum Receives FDA IND Clearance to Initiate a Phase 1/2 Clinical Trial for BPX-603, a Dual-Switch GoCAR-T® for HER2+ Solid Tumors

On June 15, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for BPX-603 (Press release, Bellicum Pharmaceuticals, JUN 15, 2020, View Source [SID1234561105]). BPX-603 is a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2). BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates both the company’s iMC activation and CaspaCIDe safety switch technologies.

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"The FDA’s clearance of our IND for BPX-603 marks a significant milestone for Bellicum, adding a second clinical program to further evaluate our novel GoCAR-T technology’s ability to enhance CAR-T and host immune cell activity against solid tumors," said Rick Fair, President and Chief Executive Officer of Bellicum. "We look forward to initiating our Phase 1/2 trial with BPX-603 targeting solid tumors that express HER2 later this year."

HER2 is a validated antigen for cancer therapies and academic CAR-T cell clinical studies have shown evidence of modest antitumor activity. BPX-603 was designed to improve upon these efforts, primarily through incorporation of the inducible co-activation domain MyD88/CD40, or "iMC". MC signaling is believed to boost effector cell proliferation and survival; enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment; and stimulate the cancer patient’s own immune system. Additionally, Bellicum’s dual-switch technology—which enables the clinician to either activate or eliminate GoCAR-T cells with the administration of small molecules—is designed to enhance real-time control of both efficacy and safety.