FDA Clears Application to Study Stem Cell-Based Treatment for High-Grade Glioma

The FDA has approved a clinical trial for CLD-101, a novel stem cell-based treatment that uses oncolytic viruses to target and destroy high-grade glioma tumors.

The Food and Drug Administration (FDA) cleared an investigational new drug application for CLD-101, a novel stem cell-based platform to deliver oncolytic viruses to tumors, to be studied in a phase 1b/2 clinical trial in patients with high-grade glioma.

With an investigational new drug application, a pharmaceutical company — in this instance, Calidi Biotherapeutics — is requesting permission from the FDA to determine whether an investigational drug is safe and effective through clinical trials.

According to the National Cancer Institute in particular, an oncolytic virus is a type of targeted therapy that infects and breaks down cancer cells and not normal cells. This approach to treatment may make it easier to destroy cancer cells with radiation and chemotherapy.

“This [investigational new drug] clearance marks an important achievement in the fight against high-grade glioma, one of the most challenging cancers to treat,” Dr. Maciej S. Lesniak, chairman of the department of neurological surgery at Northwestern University Feinberg School of Medicine in Chicago and member of the scientific and medical advisory board for Calidi Biotherapeutics, said in a press release from the company. “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.”

The phase 1b/2 clinical trial will be conducted at Northwestern University starting late 2024, according to the release. This open-label study was to evaluate the feasibility and safety of multiple doses of CLD-101 in patients with newly diagnosed high-grade glioma. Patients enrolled in the study will have high-grade glioma confirmed by biopsy, and will receive doses of CLD-101 plus surgery, radiation therapy and chemotherapy.

A phase 1 dose-escalation study on CLD-101 was completed in 2021 in patients with newly diagnosed high-grade glioma. In this study, CLD-101 was administered into the resection cavity walls after neurological resection of the tumor, according to the release. Results from this study demonstrated that treatment with CLD-101 was safe and feasible with no dose-limited toxicities observed. Patients in this study experienced anti-tumor immune responses from treatment with CLD-101. Treatment with the novel therapy elicited a median progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening) of 9.05 months and a median overall survival (the time when a patient with cancer is still alive) of 18.4 months.

“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, a notoriously difficult to treat cancer, with a five-year survival rate in adults of just 5% to 10%,” Allan Camaisa, CEO and Chairman of the Board of Calidi, said in the release. “Encouraged by these results, we continue to believe that CLD-101 offers a novel therapeutic option for patients with high-grade glioma.”

CLD-101 is also being studied in a phase 1 trial conducted in patients with recurrent high-grade glioma, for which interim results will be reported in the first half of 2025, according to the release.

According to the American Cancer Society, gliomas are tumors that start in glial cells, which support the nervous system. Most fast-growing tumors occurring in the brain are gliomas, and nearly three out of 10 brain tumors are considered gliomas. High-grade gliomas indicate that the cells are growing and spreading quickly to surrounding areas of brain tissue.

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