Calidi announces FDA clearance of Northwestern University’s IND application

Calidi Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared Northwestern University’s Investigational New Drug application for Calidi’s CLD-101. CLD-101 is a novel stem-cell based platform designed to deliver oncolytic viruses to tumors, enhancing their antitumor effects. The Phase 1b/2 clinical trial is expected to commence in late 2024 at Northwestern University. The Phase 1b/2 open label study of CLD-101 will evaluate the safety and feasibility of administering multiple doses of CLD-101 in patients with newly diagnosed high-grade glioma. Eligible patients, with a confirmed biopsy diagnosis, will receive repeated doses of CLD-101 in addition to surgery, standard-of-care radiation therapy, and chemotherapy.