Calidi Biotherapeutics, Inc. (NYSE American: CLDI) announced that the FDA has cleared Northwestern University’s Investigational New Drug (IND) application for CLD-101, a novel stem-cell based platform designed to deliver oncolytic viruses to tumors. The Phase 1b/2 clinical trial is expected to commence in late 2024 at Northwestern University.
The open-label Phase 1b/2 study will assess the safety and feasibility of multiple doses of CLD-101 in newly diagnosed high-grade glioma patients. Eligible patients, confirmed via biopsy, will receive repeated doses of CLD-101 alongside surgery, standard radiation therapy, and chemotherapy.
Clinical Trial Details
The Phase 1b/2 trial is designed to evaluate the safety and feasibility of administering multiple doses of CLD-101 to patients newly diagnosed with high-grade glioma. This open-label study will enroll patients with confirmed diagnoses who will receive CLD-101 in conjunction with standard treatments, including surgery, radiation, and chemotherapy.
Mechanism of Action
CLD-101 is a novel allogeneic immunotherapy that uses neural stem cells to deliver engineered oncolytic adenoviruses directly to tumor sites. This targeted delivery aims to enhance the antitumor effects of the virus while minimizing harm to healthy tissues.
Prior Clinical Experience
A previous Phase 1 dose-escalation study of CLD-101 (NSC/CRAd-S-pk7) at Northwestern University in newly diagnosed high-grade glioma patients showed the treatment was feasible and safe, with no dose-limiting toxicities. The study, with findings published in Lancet Oncology in 2021, also observed anti-tumor immune responses, with a median progression-free survival of 9.05 months and overall survival of 18.4 months.
Expert Commentary
Maciej S. Lesniak, MD, Chairman of the Department of Neurological Surgery at Northwestern University Feinberg School of Medicine and Member of Calidi’s Scientific and Medical Advisory Board, stated, “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.”
Dr. Alfred Yung, Calidi Medical Advisory Board member and advisor to the White House Cancer Moonshot initiative, added, “I have been very impressed by Dr. Lesniak’s promising work in high-grade glioma patients using CLD-101 (NeuroNova), and I am very pleased by this FDA clearance, which enables this groundbreaking research to continue in further clinical trials.”
Ongoing Research
CLD-101 is also under evaluation in a Phase 1 trial for recurrent high-grade glioma patients in collaboration with City of Hope, with interim clinical data expected in the first half of 2025. City of Hope received $5.3 million from the California Institute for Regenerative Medicine (CIRM) to support preclinical studies, manufacturing, and clinical trial design for CLD-101 in ovarian cancer.
