SAN DIEGO, Calif. — 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, today announced 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.
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.
About Calidi Biotherapeutics
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company pioneering the development of targeted therapies that can deliver genetic medicines to sites of disease. The company’s proprietary Redtail platform represents a decade of development and expertise in designing viral vectors that can evade immune detection allowing for systemic delivery and distal sites of disease in oncology and, potentially, other indications. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent gene therapies to metastatic locations.
The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing clinical-stage protected virotherapies for intratumoral and localized administration, focusing on a subset of injectable cancer indications.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or follow at X .
Contact
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
[email protected]