CERo Therapeutics Receives FDA Clearance For Second Clinical Trial Of CER-1236 In Solid Tumors

(RTTNews) - CERo Therapeutics Holdings, Inc. (CERO), a company specializing in immunotherapy, has secured clearance from the U.S. Food and Drug Administration - FDA for a second Investigational New Drug - IND application for its lead compound, CER-1236.

The approval allows the initiation of a Phase 1 clinical trial targeting advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer.

The company's Chief Medical Officer, Robert Sikorski, M.D., Ph.D., highlighted the significance of expanding CER-1236's evaluation into solid tumors. He emphasized that this therapy is the first CAR-T cell treatment designed to target Tim-4L while incorporating phagocytic activity, a dual mechanism that could address resistance barriers in solid tumor CAR-T trials. Sikorski also acknowledged the FDA's role in accelerating development and enabling the company to run concurrent trials for both hematologic and solid tumors, reinforcing the therapeutic and commercial potential of CER-1236.

Preclinical data demonstrated CER-1236's effectiveness against ovarian cancer cells without causing toxicity in animal models. Assessments post-infusion revealed T cell engraftment in lymphoid organs but no clinical pathology or histopathological signs of toxicity.

CERo CEO Chris Ehrlich acknowledged the team's dedication in advancing the ongoing Phase 1 AML trial in the U.S. and expressed enthusiasm for providing updates on both trials in the near future.

CERO is currently trading at $0.7345 or 2.1971% lower on the Nasdaq Capital Market.