Calidi Presents Scalable CLD-401 Manufacturing with FDA Feedback Supporting Clinical Path
Calidi Biotherapeutics detailed its in-house scalable, high-yield manufacturing process for CLD-401, featuring a CD55 over-expressing envelope to prevent immune clearance and support systemic delivery. FDA Type D meeting feedback validated this process for clinical development and paves the way for an IND submission by year-end 2026.
1. Manufacturing Process Presentation
At the 9th Annual Bioprocessing Summit in Barcelona, Calidi unveiled its proprietary in-house process for CLD-401 manufacturing. The system emphasizes high-yield production and preserves the engineered CD55 over-expressing viral envelope, critical for evading immune detection and enabling systemic tumor targeting.
2. FDA Feedback and Clinical Pathway
Calidi engaged the FDA through a Type D meeting request to review its manufacturing and analytical strategies. The agency’s supportive feedback confirms the process meets regulatory expectations for advancing CLD-401 into clinical studies.
3. IND Timeline and Platform Expansion
CLD-401 remains in IND-enabling studies with plans to file an Investigational New Drug application by the end of 2026. Concurrently, Calidi is refining the RedTail platform and seeking strategic partnerships to accelerate development and broaden its virotherapy pipeline.