SAN DIEGO & LOS ANGELES, Calif. — Calidi Biotherapeutics Inc. (NYSE American: CLDI), 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 announced 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. 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.
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.
Karen 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.
About Calidi Biotherapeutics
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease.
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 U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix.
About the California Institute for Regenerative Medicine (CIRM)
At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.
Contacts
For Investors:
Stephen Jasper
Gilmartin Group
[email protected]
For Media:
Calidi Biotherapeutics
Stephen Thesing
[email protected]
City of Hope:
Letisia Marquez
[email protected]