Core Insights - Calidi Biotherapeutics, Inc. has received Fast Track designation from the FDA for its product CLD-201, an allogeneic adipose stem-cell loaded oncolytic virus aimed at treating soft tissue sarcoma [1][2][3] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies that can deliver genetic medicines to disease sites [5][6] - The company's proprietary Redtail platform has been developed over a decade, allowing for the design of viral vectors that evade immune detection, facilitating systemic delivery to tumor sites [5] Product Details - CLD-201 consists of adipose-derived mesenchymal stem cells loaded with an oncolytic vaccinia virus, targeting advanced solid tumors such as sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma [4] - The stem-cell loading mechanism protects the virus from immune clearance, enhancing its potency and efficacy in pre-clinical models [4] Regulatory Milestones - The FDA's Fast Track designation will enable more frequent interactions with the agency and may lead to priority review and accelerated approval for CLD-201 [2][3] - The FDA Investigational New Drug (IND) clearance for CLD-201 was previously announced on April 17, 2025, with a planned Phase 1 trial to evaluate its safety and efficacy [3]