CLD-401

June 16, 2026: Calidi Biotherapeutics, Inc. (NYSE: CLDI) reported it received pre-IND (Type B) regulatory feedback from the U.S. FDA for CLD-401, providing alignment on IND-enabling preclinical plans and the clinical strategy ahead of Phase 1. The company said the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs and provided feedback on the overall design of the proposed first-in-human study; the interaction builds on earlier scientific advice via a Type D interaction. Calidi described CLD-401 as an oncolytic virus with in situ delivery of an IL-15 superagonist and stated it is currently in IND-enabling studies targeting non-small cell lung cancer, head and neck cancer, and other tumor types. Calidi plans to submit the IND for CLD-401 by year-end 2026 and aims to initiate its first-in-human clinical trial in early 2027.