SAN DIEGO, July 29, 2025 (GLOBE NEWSWIRE) -- 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.
Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward looking statements include, but are not limited to, statements concerning use of proceeds from the offering, that the closing of offering will occur or will occur on the anticipated closing date, upcoming key milestones, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Form 10-K filed on March 31, 2025 and Form 10-Q filed on May 14, 2025. These reports may be amended or supplemented by other reports we file with the SEC from time to time.
Contact:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com
