CERo Therapeutics Holdings Receives FDA Clearance of Second Investigational NDA to Initiate Phase 1 Clinical Trial of Lead Compound CER-1236 in Solid Tumors

CERo Therapeutics Holdings, Inc. recently announced it has received clearance by the US FDA for a second Investigational New Drug (IND) application for lead compound CER-1236 for a Phase 1 clinical trial in advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer.

CERo Chief Medical Officer Robert Sikorski, M.D., Ph.D. commented, “Following the launch of our AML trial, we are now starting a second clinical study of CER-1236 to evaluate its potential in solid tumors and bring new therapeutic options to patients with ovarian and lung cancer,” said Robert Sikorski, M.D., Ph.D., Chief Medical Officer of CERo. “CER-1236 is novel: the first CAR-T cell therapy to target Tim-4L and the first with phagocytic activity programmed into a T cell. Preclinical data suggest that this dual mechanism may help overcome key resistance barriers that have hampered solid tumor CAR-T trials. The FDA’s collaborative role has been critical to maintaining development velocity and enabling us to operate two open trials in both hematologic and solid tumors. Taken together, this expansion reflects our belief in the therapeutic breadth and the commercial and partnering potential of CER-1236.”

The company recently announced data showing that CER-1236 treated ovarian cancer cells and did not generate toxicity in animal models (mice).  Investigators found that following dosing, assessment of clinical and anatomic pathology after CER-1236 infusion showed T cell engraftment in lymphoid organs, but there were no in-life observations, clinical pathology, nor histopathological evaluations indicating toxicity caused by the compound.

“Of note, our team has been simultaneously progressing our Phase 1 AML trial in the US.  Their incredible efforts cannot be under-emphasized, and I wish to convey my gratitude to our extremely competent and efficient team.  We are looking forward to sharing progress on each of our two Phase 1 clinical trials in the near term,” added CERo CEO Chris Ehrlich.

CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected 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 (CER-T). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor (CAR-T) cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in 2025 for hematological malignancies.