CERO Therapeutics Holdings, Inc. announced on November 15, 2024, that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application. This clearance allows the company to initiate Phase 1 clinical trials for its lead compound, CER-1236, in acute myelogenous leukemia (AML).
The FDA's decision follows productive discussions between CERO Therapeutics and the agency, paving the way for the first-in-human trial of CER-1236. This marks a pivotal point in the development of the company's novel engineered T-cell therapy.
CERO Therapeutics anticipates commencing its Phase 1 trial in the first quarter of 2025. The company believes CER-1236 offers a novel and powerful approach to treating AML, one of the deadliest cancers, and looks forward to exploring its differentiated attributes in the upcoming clinical study.
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