On March 11, 2024 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted oncolytic virotherapies, and City of Hope, one of the largest cancer research and treatment organizations in the United States, today jointly reported that the California Institute for Regenerative Medicine (CIRM) has awarded Karen Aboody, M.D., City of Hope professor in the Department of Stem Cell Biology and Regenerative Medicine and Division of Neurosurgery, a $5.3 million grant to fund preclinical translational studies, product manufacturing, and clinical trial design using Calidi’s licensed oncolytic virotherapy product, CLD-101, in patients with chemo-resistant, metastatic ovarian cancer (Press release, Calidi Biotherapeutics, MAR 11, 2024, View Source [SID1234641041]). CLD-101 is the lead therapeutic candidate in Calidi’s NeuroNova program, comprising tumor-tropic neural stem cells (NSCs) that deliver an oncolytic adenovirus (NSC-CRAd-S-pk7) selectively to tumor sites.
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!
Aboody and her team have been key collaborators with Calidi over the past four years, and Calidi’s knowledge and expertise has enhanced key attributes of the CLD-101 program, in particular Calidi’s next generation manufacturing process and potency optimization, leading to higher yields and improved oncolytic activity of the CLD-101 product for use in high-grade glioma, and now ovarian cancer. This proposed CLD-101 treatment utilizes a neural stem cell line to deliver an oncolytic adenovirus directly to abdominal ovarian tumor sites. The virus infects and kills the tumor cells, even if they are chemo-resistant, which then stimulates the patient’s immune system to infiltrate, recognize, and fight the tumor. In collaboration with Calidi, Aboody will lead the groundbreaking work.
"We are delighted to receive this financial support from CIRM, which enables us to complete the preclinical translational studies, product manufacturing, and clinical trial design needed for FDA approval to move this novel treatment to ovarian cancer patients within two to three years. This CIRM grant will allow us to further utilize Calidi’s manufacturing processes, which we believe will optimize the potency of the CLD-101 oncolytic virotherapy treatment product, and improve clinical outcomes for women with stage III ovarian cancer," said Aboody.
"This is the third grant from CIRM supporting the development of Calidi’s assets, further validating our novel cell therapy platforms and their versatility for multiple cancer indications," said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. "We have been focused on enhanced cell manufacturing processes and providing novel options to patients with a variety of serious cancers, and we are grateful for the continued support from CIRM, as we advance our clinical programs."
In July 2023, Calidi announced the dosing of the first patient in a City of Hope Phase 1 clinical trial evaluating CLD-101 in recurrent high-grade glioma patients. The company expects to provide a clinical update in the first half of 2024. Additionally, a previously completed Phase 1 dose escalation trial assessed the safety of a single dose of CLD-101 administered into the walls of the surgical resection cavity, in newly diagnosed high-grade glioma patients. In this trial, CLD-101 demonstrated safety and the stimulation of an anti-tumor response, with results published in Lancet Oncology.
For more information about this trial, click here or contact [email protected] or (626) 218-4062.
Aboody has financial interest in and is a paid advisory board member for Calidi Biotherapeutics.
About CLD-101
The CLD-101 platform, which includes NSC-CRAd-S-pk7, is an allogeneic, "off-the-shelf" therapy comprised of an immortalized NSC line loaded with an engineered oncolytic adenovirus. In High Grade Glioma brain cancer patients, upon surgical resection of tumor, NSC-CRAd-S-pk7 is injected into the walls of the resection cavity. The anti-cancer virus it releases is expected to infect and kill any remaining tumor cells, which is also postulated to stimulate a tumor-specific immune response from the patient. Calidi holds an exclusive worldwide licensing agreement covering the NSC-CRAd-S-pk7 technology.