Calidi Biotherapeutics and City of Hope Announce First Patient Dosed in a Phase 1 Clinical Trial Evaluating Neural Stem Cells Engineered to Carry an Oncolytic Virus, CLD-101, in Recurrent High-grade Glioma Patients
- City of Hope and Calidi Biotherapeutics have treated the first brain tumor patient in a Phase 1 clinical trial for CLD-101, a therapeutic candidate that shows promise in treating recurrent high-grade glioma.
- The previous Phase 1 trial demonstrated that CLD-101, when used in conjunction with standard radiation and temozolomide, was well-tolerated and stimulated an anti-tumor immune response.
- Calidi plans to sponsor a Phase 1b/2 trial to further advance CLD-101 treatment for newly diagnosed glioma patients.
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Calidi holds an exclusive worldwide licensing agreement for patents covering the NSC-CRAd-S-pk7 for its CLD-101 technology. The trial seeks to determine the safety, immunogenicity and preliminary clinical efficacy of treatment with multiple intracerebral doses of CLD-101 in patients with recurrent high-grade glioma.
“The dosing of the first patient in our Phase 1 clinical trial is a significant achievement in our efforts to find new treatment options for patients with brain cancer,” said Jana Portnow, M.D., the study’s principal investigator, professor of medical oncology and co-director of City of Hope’s Brain Tumor Program. “Recurrent glioblastoma is notoriously challenging to treat. These are resistant tumor cells that have survived radiation and chemotherapy and spread to other regions of the brain.
“CLD-101 is designed to protect and better distribute the anti-cancer virus to sites of tumors distant from the main tumor mass,” Portnow said. “Studies in mice showed that CLD-101 is effective against tumor cells that are resistant to radiation and chemotherapy. We are excited to now assess the safety and potential efficacy of multiple intracerebral doses of CLD-101.”
A previously completed Phase 1 dose escalation clinical trial assessed the safety of administering a single dose of CLD-101 into the surgical cavity of newly diagnosed high-grade glioma patients. CLD-101 as an adjunct to standard radiation and temozolomide was well-tolerated and demonstrated safety as well as stimulation of an anti-tumor immune response. These results were published in Lancet Oncology, 2021. Calidi plans to sponsor a Phase 1b/2 trial to further advance CLD-101 treatment of newly diagnosed glioma.
“We have extensive experience using NSCs to deliver anti-cancer payloads selectively to invasive and distant tumor sites. Our research combining NSCs, our studies with oncolytic viruses, as well as a proven track record by City of Hope and Calidi in GMP manufacturing of stem cell and gene therapy products, well positions our City of Hope team to advance the CLD-101 technology in patients,” said Karen Aboody, M.D., professor, Division of Stem Cells & Cancer Therapeutics, scientific leader of the neuro-oncology disease team at City of Hope and a Calidi advisory board member. “In contrast to the administration of free oncolytic virus, which is rapidly inactivated by the patients’ immune cells, our tumor-targeting NSCs act as a kind of `Trojan horse,’ shielding and protecting the anti-cancer virus en route to tumor sites.”
“This allows significantly more virus to reach the tumor sites, generating more tumor cell death and leading to the stimulation of a secondary tumor-specific immune response,” Aboody said. “Our goal is to improve clinical outcomes, as well as to decrease the devastating side effects associated with currently available treatments, to improve the patient’s quality of life.”
The California Institute for Regenerative Medicine recently awarded a
“We are pleased to have formed a very productive partnership with City of Hope and look forward to working closely through this critical next step in our CLD-101 development program. Calidi is committed to the clinical advancement of stem cell platforms to deliver oncolytic viruses directly to the main tumor mass and sites of distant tumor, potentially bringing significant therapeutic benefits to cancer patients,” said Boris R. Minev, M.D., president, medical and scientific affairs of Calidi Biotherapeutics. “In addition to brain cancer, we are investigating the potential of this novel technology to successfully treat other tumor types as well.”
For more information about this trial, click here or contact fbidmeshki@coh.org (626) 218-4062.
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. 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. A second mechanism of cytoxicity is that the oncolytic virus can elicit a tumor-specific immune response from the patient. Calidi holds an exclusive worldwide licensing agreement covering the NSC-CRAd-S-pk7 technology.
About Calidi Biotherapeutics
Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery and potentiation of oncolytic viruses for targeted therapy against difficult-to-treat cancers. Calidi Biotherapeutics is advancing to clinical development potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. Calidi’s off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses currently in development leading to enhanced efficacy and improved patient safety. Calidi Biotherapeutics is headquartered in
About City of Hope
City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the
Forward-Looking Statements
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For Media:
City of Hope
Letisia Marquez
lemarquez@coh.org
(626) 476-7593
Calidi Biotherapeutics
Stephen Thesing
Sthesing@calidibio.com
(858) 794-9600
For Investors:
Gilmartin Group
Stephen Jasper
stephen@gilmartinir.com
Source: Calidi Biotherapeutics, Inc.
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