US-based biotechnology company Calidi Biotherapeutics has received the US Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application for CLD-201.
CLD-201 is an allogeneic stem cell-based immunotherapy that uses adipose tissue-derived stem cells combined with oncolytic vaccinia virus.
The drug is expected to enter clinical development for treating solid tumours in adults, breast cancer, head and neck cancer, and soft tissue sarcoma.
The IND application was based on preclinical data showcasing CLD-201’s ability to evade viral inactivation by the patient’s immune system and target and destroy cancer cells.
Future clinical trials will evaluate the safety, tolerability, and preliminary efficacy of CLD-201 in patients with challenging-to-treat tumours, a significant unmet medical need.
Calidi medical and scientific affairs president Boris Minev said: “This remarkable achievement underscores the innovative approach and dedication of our exceptional team.
“The potential of CLD-201 to revolutionise the treatment of multiple solid tumours is truly exciting.
“We are eager to see its clinical application in providing new hope and improved outcomes for patients battling these challenging cancers.”
Calidi said the FDA IND approval of its allogeneic virotherapy product represents a novel approach to cancer treatment.
Based in San Diego, California, Calidi is a clinical-stage immuno-oncology company developing unique technology to enhance the immune system’s ability to combat cancer.
Its advanced stem cell-based platforms employ potent allogeneic stem cells that can deliver oncolytic viruses for various oncology indications, including gliomas and solid tumours.
Calidi’s clinical-stage off-the-shelf, universal cell-based delivery platforms aim to protect, amplify, and potentiate oncolytic viruses, leading to improved efficacy and patient safety.
Calidi CEO and chairman Allan Camaisa said: “I am proud of our executives and staff that have worked tirelessly to make this application possible.”
Calidi chief scientific officer and technical operations head Antonio Santidrian said: “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.”
