On July 29, 2025 Calidi Biotherapeutics, Inc. ("Calidi" or the "Company") (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, reported that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company’s allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma (Press release, Calidi Biotherapeutics, JUL 29, 2025, View Source [SID1234654607]).

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Fast Track designation is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. CLD-201 will benefit from this designation through more frequent interactions with the FDA along with potential eligibility for priority review and accelerated approval.

Guy Travis Clifton, M.D., Chief Medical Officer of Calidi commented, "FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the unmet medical need in sarcoma and provides scientific and regulatory validation of CLD-201. We believe CLD-201 has the potential to provide durable and transformational treatment to patients with sarcoma as well as patients with other advanced tumor types. We want to thank the FDA for its support and partnership and look forward to continued collaboration with the agency."

FDA Investigational New Drug (IND) clearance for CLD-201 was announced on April 17, 2025. The planned Phase 1 trial will be a first-in-human, open-label, multicenter study to evaluate the safety, tolerability and efficacy of CLD-201 in sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.

About CLD-201

CLD-201 is comprised of adipose-derived mesenchymal stem cells (AD-MSC) loaded with oncolytic vaccinia virus, for the treatment of patients with advanced solid tumors including sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma. Stem-cell loading of an oncolytic virus helps protect the virus from clearance by the body’s immune system and allows virus to amplify within the stem cell, leading to an increase in potency and immune activation and enhanced efficacy in pre-clinical animal models.