Oct.10. 2022 eXCELL, Inc., granted a pre-pre-Investigational IND for Regulatory Advice on CBER products INTERACT meeting with U.S. FDA

eXCELL, Inc., a leader in developing the next generation of xenogeneic cell immunotherapies for cancer and infectious diseases, has been granted a pre-pre-Investigational New Drug (“IND”) Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) meeting with the U.S. Food and Drug Administration (“FDA”) on November 18th, 2022 to discuss the initial pre-clinical and clinical development plan for URO X (expanded xenogeneic urothelial cells) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), a highly unmet need in bladder cancer. An INTERACT meeting is conducted to develop mutual understanding and agreement between the FDA and the Company regarding manufacturing, pre-clinical pharmacology and toxicology, as well as rationale to support a first in humans clinical trial.