FDA clears IND application for ’dual-switch’ CAR-T for HER2-positive tumors
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The FDA cleared an investigational new drug application for BPX-603, a chimeric antigen receptor T-cell therapy for the treatment of HER2-positive solid tumors, according to a press release from the agent’s manufacturer.
BPX-603 (Bellicum Pharmaceuticals) is an autologous CAR T-cell therapy that uses Bellicum’s proprietary dual-switch GoCAR-T. The technology allows clinicians to either activate or eliminate the CAR T cells with the administration of small molecules to enhance real-time control of the agent.
BPX-603 targets tumors that express HER2. The approval allows Bellicum to move forward with a phase 1/phase 2 clinical trial to evaluate the safety and efficacy of BPX-603 for HER2-positive solid tumors.
Previous studies of CAR T-cell technology that targets HER2-postive tumors have shown some antitumor activity but have been limited by modest clinical efficacy and off-tumor/on-target toxicity, according to Bellicum.
“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,” Rick Fair, president and CEO of Bellicum, said in the release. “We look forward to initiating our phase 1/2 trial with BPX-603 targeting solid tumors that express HER2 later this year.”
Bellicum is conducting a phase 1/phase 2 clinical trial of its GoCAR-T technology among patients with pancreatic, gastric or prostate cancers whose tumors express the prostate stem cell antigen.
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