On April 17, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201 (Press release, Calidi Biotherapeutics, APR 17, 2025, View Source [SID1234653210]). This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head & neck cancer and soft tissue sarcoma.
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The IND application included preclinical data demonstrating the potential of CLD-201 to evade viral inactivation by the patient’s immune system and effectively target and kill cancer cells. The upcoming clinical trials will assess the safety, tolerability, and preliminary efficacy of CLD-201 in patients with these difficult-to-treat tumors, addressing significant unmet medical needs.
"This FDA-cleared IND is a monumental milestone for Calidi Biotherapeutics and for patients worldwide. This allogeneic virotherapy product can transform how we treat cancer. It’s a one-of-a-kind product that has never been manufactured before using adipose tissue-derived stem cells in combination with oncolytic vaccinia virus. Its versatility in being able to treat solid tumors is remarkable," said Allan Camaisa, CEO and Chairman at Calidi. "I am proud of our executives and staff that have worked tirelessly to make this application possible."
"This remarkable achievement underscores the innovative approach and dedication of our exceptional team. The potential of CLD-201 to revolutionize the treatment of multiple solid tumors is truly exciting. We are eager to see its clinical application in providing new hope and improved outcomes for patients battling these challenging cancers," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi.
"This milestone is a testament to the comprehensive and robust pre-clinical, CMC, and development package supporting the clinical advancement of CLD-201. It highlights the expertise and dedication of Calidi’s teams in pushing forward innovative immunotherapies," said Antonio F. Santidrian, PhD, Chief Scientific Officer & Head of Technical Operations at Calidi.