Calidi Biotherapeutics (NYSE American: CLDI) has achieved a significant milestone as the U.S. Food and Drug Administration (FDA) cleared Northwestern University's Investigational New Drug (IND) application for CLD-101, a pioneering stem cell-based platform designed to enhance antitumor effects through targeted oncolytic virus delivery.
The upcoming Phase 1b/2 open-label study, scheduled to begin in late 2024 at Northwestern University, will evaluate multiple doses of CLD-101 in newly diagnosed high-grade glioma patients. The treatment protocol will integrate CLD-101 with standard-of-care treatments, including surgery, radiation therapy, and chemotherapy.
Previous Clinical Success Drives Development
A completed Phase 1 dose-escalation study in 2021 demonstrated encouraging results. The trial, which involved direct administration of CLD-101 into surgical resection cavity walls, showed notable safety profiles with no dose-limiting toxicity. The treatment achieved a median progression-free survival of 9.05 months and overall survival of 18.4 months, with results published in Lancet Oncology.
Dr. Maciej S. Lesniak, Chairman of the Department of Neurological Surgery at Northwestern University Feinberg School of Medicine, emphasized the significance of this development: "This IND clearance marks an important achievement in the fight against high-grade glioma, one of the most challenging cancers to treat. Our research on the ability of stem cells to protect oncolytic viruses and deliver them to tumors suggests the potential of CLD-101 in the treatment of brain cancer."
Expanding Clinical Program
The development program for CLD-101 extends beyond the Northwestern University trial. A parallel Phase 1 trial is currently underway at City of Hope for recurrent high-grade glioma patients, with interim clinical data expected in the first half of 2025. The program has garnered substantial support, including a $5.3 million grant from the California Institute for Regenerative Medicine (CIRM) for expanding research into ovarian cancer applications.
Addressing Critical Unmet Needs
High-grade glioma presents a significant therapeutic challenge, with adult patients facing a mere 5-10% five-year survival rate. Allan Camaisa, CEO and Chairman of Calidi, highlighted the treatment's potential impact: "The promising results from our previously completed trial with Northwestern University demonstrated the safety and potential efficacy of CLD-101 in patients with newly diagnosed high-grade glioma. We continue to believe that CLD-101 offers a novel therapeutic option for patients."
Dr. Alfred Yung, a Calidi Medical Advisory Board member and Blue Ribbon Panel advisor to the White House Cancer Moonshot initiative, added his endorsement: "I have been very impressed by Dr. Lesniak's promising work in high-grade glioma patients using CLD-101, and I am very pleased by this FDA clearance, which enables this groundbreaking research to continue in further clinical trials."
