FDA Clears Northwestern University's IND for CLD-101 High-Grade Glioma Trial

Calidi Biotherapeutics, Inc. (NYSE American: CLDI), a clinical-stage biotechnology company specializing in targeted antitumor virotherapies, has received clearance from the U.S. Food and Drug Administration (FDA) for Northwestern University's Investigational New Drug (IND) application for CLD-101. This novel treatment leverages a stem cell-based platform to deliver oncolytic viruses to tumors, aiming to enhance antitumor effects. The Phase 1b/2 clinical trial is set to begin in late 2024 at Northwestern University and will evaluate the safety and feasibility of multiple doses of CLD-101 in patients newly diagnosed with high-grade glioma.

Patients diagnosed via biopsy and eligible for the trial will receive repeated doses of CLD-101, alongside standard treatments like surgery, radiation therapy, and chemotherapy. The goal of the study is to understand the safety and practicality of using this treatment in a clinical setting. Maciej S. Lesniak, MD, Chairman of the Department of Neurological Surgery at Northwestern University Feinberg School of Medicine and a member of Calidi's Scientific and Medical Advisory Board, emphasized the significance of this IND clearance. He noted that stem cells' ability to protect and deliver oncolytic viruses to tumors could make a substantial difference in treating brain cancer, particularly high-grade gliomas, one of the most challenging forms of cancer.

Dr. Alfred Yung, another prominent member of Calidi's Medical Advisory Board and advisor to the White House Cancer Moonshot initiative, expressed optimism about the FDA's decision. He acknowledged the promising work done by Dr. Lesniak and highlighted the importance of continuing this groundbreaking research through further clinical trials. Dr. Yung is also a professor of Neuro-oncology at The University of Texas MD Anderson Cancer Center.

In 2021, a Phase 1 dose-escalation study of CLD-101 was conducted at Northwestern University, involving patients with newly diagnosed high-grade glioma. Following neurosurgical resection, CLD-101 was administered directly into the resection cavity walls. The study found the treatment to be both feasible and safe, with no significant dose-limiting toxicity observed. Moreover, the trial showed encouraging results, with a median progression-free survival of 9.05 months and an overall survival of 18.4 months. These findings were published in Lancet Oncology.

Allan Camaisa, CEO and Chairman of the Board of Calidi, highlighted the promising results from this previous trial as a motivating factor for continuing to develop CLD-101. He noted that high-grade glioma remains notoriously difficult to treat, with a five-year survival rate of just 5 to 10 percent in adults. Camaisa emphasized Calidi's commitment to developing novel immunotherapies to target some of the most challenging tumor types.

Additionally, CLD-101 is being evaluated in a Phase 1 trial at City of Hope, a non-profit clinical research center, for recurrent high-grade glioma patients. Interim clinical data from this trial is expected in the first half of 2025. City of Hope was awarded $5.3 million by the California Institute for Regenerative Medicine (CIRM) to support preclinical studies, manufacturing, and clinical trial design for CLD-101 in ovarian cancer.

Calidi Biotherapeutics is headquartered in San Diego, California, and is focused on creating innovative stem cell-based platforms to enhance the efficacy of oncolytic viruses. These platforms are designed to protect and amplify the viruses, leading to better patient outcomes and safety. The company's dual approach aims to treat, and potentially prevent, metastatic diseases, thereby addressing some of the most challenging aspects of cancer treatment.