Positive Pre-IND Feedback from Received US FDA for CLD-401; IND enabling studies to continue with IND submission targeted by end of 2026
“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,” said Calidi Biotherapeutics Chief Executive Officer Eric Poma, Ph.D. “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. This positions us to initiate our first-in-human clinical trial in early 2027.”
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