On February 24, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, reported that Northwestern University/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product (Press release, Calidi Biotherapeutics, FEB 24, 2025, View Source [SID1234653215]).
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Calidi Biotherapeutics has completed the shipment of the first batch of CLD-101, which comprises allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7. This batch will support a new clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer.
This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, represents a major step forward in cancer therapy. Building on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal The Lancet Oncology, the upcoming Phase 1B/2 trial introduces multiple doses of CLD-101 regime in newly diagnosed patients, aiming to enhance therapeutic efficacy and improve patient outcomes.
"I am extremely excited about the commencement of recruitment for the multiple dose CLD-101 trial in newly diagnosed HGG patients. This increases the probability of success due to the improved treatment regimen initiated as early as possible in this devastating disease," said Dr. Lesniak, chairman of the Department of Neurological Surgery at Northwestern University’s Feinberg School of Medicine. The trial has been granted funding by the NIH/NCI SPORE to support this pioneering study.
Both Dr. Lesniak and Dr. Stupp bring a wealth of experience in treating brain tumors. Dr. Stupp is globally recognized for developing the FDA-approved Stupp Protocol, a treatment that transformed Glioblastoma care.
"We are proud to have assembled a world-class team of surgeons and neuro-oncologists to lead this trial," said Allan Camaisa, Chief Executive Officer and Chairman at Calidi Biotherapeutics. "Should the results of this trial demonstrate treatment outcomes consistent with the previous study, now in a larger patient group and with multiple doses of CLD-101, the implications could be transformative for the treatment of brain tumors. Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer."