On March 26, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, and City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, reported progress from a phase 1 clinical trial utilizing Calidi’s CLD-101 investigational agent (neural stem cell-based oncolytic virotherapy) that is administered intracerebrally (Press release, Calidi Biotherapeutics, MAR 26, 2025, View Source [SID1234653216]). This trial is the first to evaluate the safety and therapeutic potential of a multiple-dose regimen of this novel virotherapy for recurrent high-grade glioma – among the most aggressive and deadly forms of brain cancer.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Conducted by City of Hope, which has a National Cancer Institute-designated Comprehensive Cancer Center known for its pioneering research, this physician-sponsored phase 1 trial is assessing the safety and feasibility of delivering up to four weekly intracerebral doses of CLD-101. To date, 14 participants have been treated and all treatment has been well tolerated. The study is currently enrolling participants to the highest treatment schedule.
"We are optimistic about the initial results in these first 14 patients. I am especially encouraged by cohort 4 as we keep enrolling participants in this highest treatment schedule," said Dr. Jana Portnow, co-director of City of Hope’s Brain Tumor Program and the trial’s principal investigator. This clinical trial is now also open at Northwestern University Feinberg School of Medicine and Stanford University Hospitals, both globally recognized institutions in cancer research and treatment.
Dr. Karen Aboody, City of Hope professor in the Department of Stem Cell Biology and Regenerative Medicine, Division of Neurosurgery, has played a critical role in developing this approach alongside Dr. Portnow. Their collaboration secured a $12 million award from the California Institute for Regenerative Medicine (CIRM) to support this groundbreaking study.
"We are dedicated to improving clinical outcomes of cancer patients with the use of stem cell technology to deliver oncolytic virus payloads to cancer sites," said Allan Camaisa, CEO and Chairman of Calidi. "Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer."
Calidi licensed the technology from the University of Chicago, on behalf of City of Hope and University of Alabama. City of Hope has a financial interest in the technology.
Dr. Aboody, an inventor of the technology, has a financial interest in Calidi and is a paid advisory board member.