CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical trial of CER-1236 in patients with acute myelogenous leukemia (AML). This clearance marks a significant milestone for CERo, paving the way for the first in-human trial of its lead compound, CER-1236, expected to commence in early 2025.
Novel Approach to AML Treatment
CER-1236 is designed as a next-generation engineered T cell therapy that integrates desirable characteristics of both innate and adaptive immunity. This novel approach aims to engage the body’s full immune repertoire to optimize cancer therapy. CERo’s proprietary T cell engineering platform redirects patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating Chimeric Engulfment Receptor T cells (CER-T).
According to CERo, CER-T cells' differentiated activity may offer greater therapeutic application than currently approved chimeric antigen receptor (CAR-T) cell therapy, potentially spanning both hematological malignancies and solid tumors.
Management Commentary
"Following our productive discussions with FDA, we look forward to initiating our first in-human trial of CER-1236 in AML," said Chris Ehrlich, Interim CEO of CERo. "We believe our lead compound offers a novel and powerful approach in treating cancer and will explore its differentiated attributes in the upcoming clinical trial in patients with one of the deadliest of all cancers, AML."
Ehrlich also thanked the CERo team for their work in bringing CER-1236 to this stage and expressed anticipation for the trial's start in the first quarter of 2025, with plans to share future program updates.
About CERo Therapeutics
CERo Therapeutics is focused on advancing the development of next-generation engineered T cell therapeutics for cancer treatment. The company's CER-T platform represents a novel cellular immunotherapy approach designed to overcome the limitations of existing CAR-T therapies by enhancing tumor cell destruction through phagocytosis.
