Calidi Secures FDA Alignment on CLD-401 Pre-IND Plans, First Human Trial in 2027
CLDI•Calidi Biotherapeutics received pre-IND feedback from FDA agreeing on CMC and nonclinical programs for CLD-401, its oncolytic virus delivering IL-15 superagonist. IND-enabling studies will continue toward a year-end 2026 submission and first-in-human trial initiation in early 2027.
1. FDA Pre-IND Meeting Outcomes
Calidi and FDA agreed on key CMC and nonclinical study designs for CLD-401, including manufacturing specifications and toxicology protocols. The FDA offered clarity on clinical trial design parameters, dosing strategies, and safety assessments needed for the Phase I study.
2. CLD-401 Development Timeline
IND-enabling studies will continue through mid-2026, with an IND submission targeted by the end of 2026. Calidi plans to launch its first-in-human trial in early 2027 and is pursuing a parallel regulatory filing for CLD-401 in Australia.
3. RedTail Platform and Strategic Outlook
CLD-401 utilizes Calidi’s RedTail platform to deliver an IL-15 superagonist via an engineered enveloped oncolytic virus aimed at metastatic tumor sites. The company is exploring strategic partnerships to accelerate clinical development and broaden the application of its proprietary gene delivery technology.
