Calidi Biotherapeutics, Inc. (NYSE: CLDI) has received crucial pre-IND feedback from the U.S. Food and Drug Administration (FDA), which provides alignment on the company’s preclinical and clinical strategy for its drug candidate CLD-401.
This feedback marks a significant step forward as Calidi prepares to advance CLD-401 into Phase 1 clinical trials.
During the pre-IND meeting, Calidi and the FDA reached an agreement on key aspects of the Chemistry, Manufacturing, and Controls (CMC) and non-clinical programs.
The discussions also covered the overall design for the proposed first-in-human clinical study, building on previous engagements with the FDA.
Calidi is focused on swiftly moving CLD-401 into clinical trials, anticipating that early Phase I data will validate its proprietary RedTail platform.
The company is also working on expanding the platform’s functionality and is actively seeking strategic partnerships to accelerate clinical development and broaden its impact.
Calidi Biotherapeutics Chief Executive Officer Eric Poma, Ph.D, commented, “We thank the FDA for its regulatory feedback, and we believe we are in agreement with the agency on our overall IND strategy for CLD-401. We look forward to our regulatory submission for CLD-401, a potentially ground-breaking oncolytic virus with in situ delivery of an IL-15 superagonist, which we are targeting by year-end.”
