CERo Therapeutics Completes IND-Enabling Activities Following Successful Manufacturing Runs for Lead Compound
CERo Therapeutics Holdings, Inc. recently announced it successfully executed pre-IND manufacturing activities for its lead therapeutic, CER-1236. The completion of multiple manufacturing runs is required to meet safety and efficacy standards for drug administration in clinical trials, and this was the final required technical activity for the company prior to completing its Investigational New Drug Application (IND) package. The company anticipates sending the IND submission to the US FDA to receive clearance to begin human trials (Phase 1) with CER-1236 in the near term.
CERo Chairman and CEO Brian G. Atwood said “This is an important milestone for CERo, paving the way for us to complete our IND package for review by the FDA, which is the final step prior to beginning clinical trials in humans. We are grateful for the hard work from our entire team as we reach this important milestone and look forward to providing updates soon regarding the outcome of the filing.”
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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