CERO Therapeutics Holdings, Inc. announced on March 31, 2025, that it has received clearance from the U.S. Food and Drug Administration (FDA) for a second Investigational New Drug (IND) application. This clearance is for its lead compound, CER-1236, to initiate a Phase 1 clinical trial in advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer.
This milestone enables CERO Therapeutics to operate two open clinical trials, one in hematologic malignancies and now one in solid tumors. Chief Medical Officer Robert Sikorski, M.D., Ph.D., emphasized that CER-1236 is novel as the first CAR-T cell therapy to target Tim-4L and the first with programmed phagocytic activity.
Preclinical data suggests that CER-1236's dual mechanism may help overcome resistance barriers in solid tumor CAR-T trials. The expansion into solid tumors reflects the company's belief in the therapeutic breadth and commercial potential of CER-1236, with the team simultaneously progressing the Phase 1 AML trial.
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