CERo Therapeutics Successfully Completes IND-Enabling Toxicology Studies for Lead Compound
CERo Therapeutics Holdings, Inc. recently announced the successful completion of toxicology studies for its lead compound, CER-1236. The toxicology studies will be included in the Investigational New Drug Application (IND) package the Company plans to send to the US FDA to receive clearance to begin human trials (Phase1) with the compound.
CERo Chairman and CEO Brian G. Atwood comments “We continue to diligently work toward the completion of our IND package for the FDA for CER-1236. Having completed these toxicology studies, we are edging closer to being ready to submit our application to the FDA to begin human Phase 1 trials. We believe CER-1236 represents a truly novel approach toward killing cancer, and we are anticipating completion of the elements for the package in the coming weeks. We look forward to continuing to update our shareholders on our progress, where appropriate.”
With these toxicology studies complete and in the company’s judgment determined to be IND-enabling, CERo is now focusing on ensuring compliant manufacturing procedures and practices, which are among the final IND-enabling studies the Company must complete ahead of the IND submission.
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 2024 for hematological malignancies.
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