CERo grabs second IND clearance for lead CAR-T cell therapy

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CERo Therapeutics has received clearance from the U.S. FDA for a second investigational new drug (IND) application for its lead compound, CER-1236, teeing up a phase 1 clinical trial in advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer.

CER-1236 represents the first CAR-T cell therapy targeting Tim-4L and incorporating programmed phagocytic activity in T cells. CERo’s cellular immunotherapy platform aims to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as “chimeric engulfment receptor T cells,” or CER-T.

The company announced in November 2024 that the FDA had cleared its IND for phase 1 clinical trials of CER-1236 in acute myelogenous leukemia (AML). CERo recently announced data showing that CER-1236 treated ovarian cancer cells and did not generate toxicity in animal (mice) models.

CERo says it will share progress on each of its two phase 1 trials “in the near term.”

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