FDA Clears IND Application for CLD-201 in Solid Tumors
The FDA has granted clearance to an investigational new drug application for CLD-201 for solid tumor treatment, based on preclinical findings.
US FDA
- The FDA has cleared the investigational new drug (IND) application for CLD-201 for the treatment of adult patients with solid tumors.
- CLD-201 is an investigational, allogeneic stem cell-based immunotherapy.
- Preclinical findings support this IND for the treatment of solid tumors, including breast cancer, head and neck cancer, and soft tissue sarcoma.
The FDA has cleared an IND application for CLD-201, an investigational, allogeneic stem cell-based immunotherapy for the treatment of adult patients with solid tumors, particularly breast cancer, head and neck cancer, and soft tissue sarcoma.1
Preclinical data has shown CLD-201’s potential to evade viral inactivation by the patient’s immune system. The agent also works to effectively target and kill cancer cells.
Clinical trials are planned to evaluate the safety, tolerability, and preliminary efficacy of CLD-201 in patients with these difficult-to-treat tumors.
Cancer cells, malignant cells, generative AI illustration: © Dr_microbe - stock.adobe.com
“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, chief executive officer and chairman at Calidi, in a press release. “I am proud of our executives and staff that have worked tirelessly to make this application possible.”
At the 2024 American Society of Clinical Oncology Annual Meeting, data from a preclinical study which evaluated the tumor selectivity and efficacy of CLD-201 in melanoma, triple-negative breast cancer, and squamous cell carcinoma models were presented.2 The study demonstrated that CLD-201 exhibits preferential amplification within tumor cells and enhanced resistance to inactivation by the humoral immune system compared with the unprotected CAL1 virus.
Notably, CLD-201 significantly inhibited tumor growth, even when given at very low doses. The agent also induced massive CD4+ and CD8+ T-cell infiltration in both treated and untreated tumors. Toxicology and biodistribution studies in immunocompromised and immunocompetent mice demonstrated a favorable safety profile for both intratumoral and systemic administration.
Overall, the study showed that CLD-201 offers advantages over autologous cell-based viral therapies, including enhanced potency, improved manufacturing, off-the-shelf availability for multiple cancer types, and lower cost.
Based on these results, a phase 1 nonrandomized clinical trial has been designed to assess the safety and initial antitumor activity of intratumoral CLD-201 administration in patients.
“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, in the press release.
"This milestone is a testament to the comprehensive and robust preclinical, [chemistry, manufacturing, and controls], 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," added Antonio F. Santidrian, PhD, chief scientific officer and head of technical operations at Calidi, in a press release.
REFERENCES:
1. Calidi Biotherapeutics announces FDA clearance of IND application for CLD-201 in solid tumors. News release. Calidi Biotherapeutics Inc. April 17, 2025. Accessed April 17, 2025. https://tinyurl.com/4hwdbjdv
2. Nguyen D, Minev I, Songco S, et al. Non-clinical evidence supporting the upcoming CLD-201 clinical trial: Cell-based oncolytic virotherapy for multiple solid tumors. J Clin Oncol 2024;42(suppl 16):2553. doi:10.1200/JCO.2024.42.16_suppl.2553
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