CERo Therapeutics (CERO) announces that the Company has received clearance by the U.S. Food and Drug Administration, FDA, for a second Investigational New Drug, IND, application for lead compound CER-1236 for a Phase 1 clinical trial in advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer. CERo Chief Medical Officer Robert Sikorski, M.D., Ph.D. commented, “Following the launch of our AML trial, we are now starting a second clinical study of CER-1236 to evaluate its potential in solid tumors and bring new therapeutic options to patients with ovarian and lung cancer,” said Robert Sikorski, M.D., Ph.D., Chief Medical Officer of CERo. “CER-1236 is novel: the first CAR-T cell therapy to target Tim-4L and the first with phagocytic activity programmed into a T cell. Preclinical data suggest that this dual mechanism may help overcome key resistance barriers that have hampered solid tumor CAR-T trials. The FDA’s collaborative role has been critical to maintaining development velocity and enabling us to operate two open trials in both hematologic and solid tumors. Taken together, this expansion reflects our belief in the therapeutic breadth and the commercial and partnering potential of CER-1236.”
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