eXCELL Biotherapeutics Inc., a biopharmaceutical company advancing xenogeneic cellular therapeutics to address unmet medical needs in oncology and infectious diseases, today announced the successful completion of a pre-pre-IND (Investigational New Drug) INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan, clinical study design and dosing strategy for the Phase I First in Human trial of URO X, a xenogeneic urothelial cell-based product, for the treatment of BCG-unresponsive, high-risk, non-muscle invasive bladder cancer patients with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
An INTERACT meeting provides the drug development sponsor an opportunity for an open communication with the FDA to discuss how to conduct early product characterization and preclinical proof-of concept studies and inform sponsors about overall early-phase clinical trial design elements as well as identify critical issues or deficiencies for sponsors to address during development to facilitate a successful IND clinical evaluation of the sponsor’s new drug candidate. After reviewing the preclinical data provided, plans for additional data generation and the Phase I First in Human clinical trial design, the FDA addressed eXCELL Biotheraputics’ questions, provided guidance and aligned with the sponsor on the proposed development plan for URO X.
We appreciate the FDA’s guidance as we endeavor to find an innovative new treatment for high unmet-need tumors with devastatingly dismal prognosis.” “We are pleased with the outcome of the INTERACT meeting with the FDA and plan to submit the pre-IND application in 2023”
said Chih-Rong, Shyr, CEO, eXCELL Biotheraputics Inc.
