Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for CLD-201, an allogeneic stem cell-based immunotherapy developed by Calidi Biotherapeutics, set to advance into clinical development for solid tumours.
The trials will assess the therapy’s safety, tolerability, and initial effectiveness in patients with challenging cancers. Credit: National Cancer Institute by Unsplash.
Subscribe to our email newsletter
This clearance is intended for treating solid tumours in adults, with a focus on head & neck cancer, breast cancer and soft tissue sarcoma.
Preclinical data included in the IND application has shown that CLD-201 has the potential to evade viral inactivation by the immune system of the subject. This allows it to target and destroy cancer cells.
The forthcoming clinical trials will evaluate the tolerability, safety and preliminary efficacy of the therapy in patients with these challenging types of cancer.
Calidi CEO and chairman Allan Camaisa said: “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 tumours is remarkable.”
Calidi Biotherapeutics, based in San Diego, California, US, specialises in stem cell-based platforms which utilise allogeneic stem cells as carriers for oncolytic viruses, aimed at treating multiple oncology indications.
The company has a particular focus on high-grade gliomas and solid tumours.
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.”
