Calidi Biotherapeutics Receives Positive Pre-IND Feedback from US FDA for CLD-401 Indicating Agreement on its Current Development Strategy as it Advances Towards a First-in-Human Study

Calidi Biotherapeutics announced it received positive pre-IND feedback from the FDA for its lead candidate CLD-401, an oncolytic virus with IL-15 superagonist delivery. The company plans to submit an IND application by end of 2026 and initiate first-in-human clinical trials in early 2027. The FDA alignment on CMC, non-clinical programs, and clinical study design represents a significant regulatory milestone for the company's RedTail platform.