Calidi Biotherapeutics Inc. Receives FDA Fast Track Designation for CLD-201 in Soft Tissue Sarcoma

Calidi Biotherapeutics Inc. (NYSE American: CLDI), a clinical-stage biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CLD-201 (SuperNova), its allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma. This designation is a critical milestone that offers opportunities for expedited development, including priority review and accelerated approval, underscoring the potential of CLD-201 to address unmet medical needs in oncology.

CLD-201, which received Investigational New Drug (IND) clearance in April, is set to enter a Phase 1 clinical trial to evaluate its safety and efficacy in treating sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma. Dr. Guy Travis Clifton, Chief Medical Officer of Calidi Biotherapeutics, highlighted that this FDA recognition validates the therapeutic potential of CLD-201 to deliver durable and transformational treatment outcomes for patients with advanced tumors.

The Fast Track designation by the FDA is a testament to the innovative approach of Calidi Biotherapeutics in developing targeted genetic medicine delivery therapies. This development not only accelerates the path to bringing CLD-201 to market but also represents a beacon of hope for patients suffering from soft tissue sarcoma and other challenging cancers.