CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces 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 U.S. Food and Drug Administration (FDA) in order 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.