Calidi Biotherapeutics Receives FDA Clearance for CLD-201 IND in Solid Tumors

SAN DIEGO, CA, USA I April 17, 2025 I Calidi Biotherapeutics Inc., a pioneering biotechnology firm focusing on targeted antitumor virotherapies, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application concerning CLD-201. This innovative immunotherapy, which is based on allogeneic stem cells, is poised to progress into clinical trials aimed at treating solid tumors in adults, with a particular focus on breast cancer, head & neck cancer, and soft tissue sarcoma.

The IND application was accompanied by preclinical data that demonstrated the ability of CLD-201 to circumvent the immune system’s viral inactivation processes and effectively target cancer cells, thereby killing them. The impending clinical trials are designed to evaluate the safety, tolerability, and initial efficacy of CLD-201 in patients dealing with these challenging tumors, which represent areas of significant unmet medical need.

Allan Camaisa, CEO and Chairman of Calidi Biotherapeutics, stated that the FDA's clearance marks a significant milestone for both the company and patients globally. He emphasized the potential of this allogeneic virotherapy product to transform cancer treatment paradigms. According to Camaisa, the use of adipose tissue-derived stem cells in combination with oncolytic vaccinia virus to create this product is unprecedented. He commended the dedication of the company's executives and staff who made the IND application a reality.

Boris Minev, MD, President of Medical and Scientific Affairs at Calidi, expressed enthusiasm about the prospect of CLD-201 revolutionizing the treatment of various solid tumors. He conveyed eagerness to observe its clinical application and the possibility of providing new hope and better outcomes for patients facing these formidable cancers.

Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi, highlighted the achievement as a testament to the comprehensive and robust pre-clinical, CMC, and development efforts that support CLD-201’s clinical advancement. He emphasized the expertise and dedication of Calidi’s teams in advancing innovative immunotherapies.

Calidi Biotherapeutics, listed on the NYSE American as CLDI, is an advanced-stage immuno-oncology company leveraging proprietary technology to enhance the immune system's ability to combat cancer. The company’s unique stem cell-based platforms employ potent allogeneic stem cells capable of transporting oncolytic viruses for a variety of oncology applications, including high-grade gliomas and solid tumors. Calidi’s clinical-stage universal cell-based delivery platforms are crafted to protect, amplify, and potentiate oncolytic viruses, which can result in increased efficacy and enhanced patient safety. Additionally, Calidi’s preclinical off-the-shelf enveloped virotherapies are tailored to target dispersed solid tumors, presenting a dual approach that holds the potential to treat or possibly prevent metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California.