• Calidi was awarded $3.1 million to support the development of Supernova-1 (SNV1) program through IND application

• City of Hope, a cancer research and treatment organization, was awarded $12 million to support a Phase 1 physician-sponsored clinical trial evaluating Calidi’s licensed oncolytic virotherapy NeuroNova-2 (NNV2) platform in patients with recurrent high-grade glioma

Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic stem cell-based platforms to revolutionize oncolytic virus immunotherapies, today announced that the California Institute for Regenerative Medicine (CIRM) has awarded the company a $3.1 million grant to support continued development of the company’s Supernova-1 (SNV1) pre-clinical program through Investigational New Drug (IND) application. In addition, CIRM has awarded City of Hope a $12 million grant to fund a Phase 1 physician-sponsored clinical trial evaluating Calidi’s licensed oncolytic virotherapy NeuroNova platform in patients with recurrent high-grade glioma, a form of advanced brain cancer.

The first grant was awarded to Calidi to support IND-enabling studies, finalize manufacturing, and the completion of Calidi’s IND application for the SNV1 program. SNV1 is composed of allogeneic, adipose-derived mesenchymal stem cells (AD-MSC) loaded with the oncolytic vaccinia virus Cal1, targeting a variety of solid tumors including metastatic/unresectable melanoma, triple negative breast cancer, and advanced head and neck squamous cell carcinoma. Calidi’s research has shown the potential ability of SNV1 to shield the viral payload from the immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses. A previously conducted physician-sponsored Phase 1 clinical trial using autologous adipose-derived stromal cells demonstrated excellent safety and early signs of efficacy in 24 patients with advanced solid tumors and two patients with acute myeloid leukemia (AML).

“With limited treatment options and poor survival rates, there remains a significant unmet need for the development of effective treatment options for patients suffering from metastatic/unresectable melanoma, triple negative breast cancer, and advanced head and neck squamous cell carcinoma,” said Boris Minev, M.D., President, Medical and Scientific Affairs of Calidi Biotherapeutics and the principal investigator of this grant. “This generous grant from CIRM will accelerate the further development of SNV1 through our IND application and beyond.”

“I have been working with an incredible team of scientists in Calidi’s research laboratories to develop this powerful off-the-shelf stem cell-based oncolytic therapy with the potential to revolutionize the treatment of solid tumors,” said Antonio F. Santidrian, Ph.D., co-inventor of SNV technology and SVP, Global Head of R&D of Calidi Biotherapeutics. “We are deeply appreciative of the CIRM funding mechanism and the unanimous vote of CIRM’s independent reviewers to support the development of SNV1, which will allow us to validate the platform in a clinical setting.”

The second grant was awarded to City of Hope to study the effects of multiple dose application of neural stem cells (NSC)-based oncolytic virotherapy in patients with recurrent high-grade gliomas. The study will utilize Calidi’s licensed NNV2 oncolytic virotherapy platform, a cutting-edge therapeutic candidate comprising tumor-tropic neural stem cells delivering an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma. The grant was awarded to City of Hope to support the manufacturing of the therapeutic agent, the conducting of the multi-center Phase 1 trial, and the determination of activity, biodistribution, immunogenicity, and preliminary clinical efficacy. The study received FDA authorization to proceed with a Phase 1 clinical trial, which will be led by principal investigator Jana Portnow, M.D., Professor in City of Hope’s Department of Medical Oncology & Therapeutics Research and Co-Director of the Brain Tumor Program at City of Hope, one of the largest cancer research and treatment organizations in the United States and a founding member of the National Comprehensive Cancer Network. Calidi holds an exclusive worldwide licensing agreement for patents covering the NSC-CRAd-S-pk7 technology (NeuroNova).

“I am honored that CIRM has recognized the expertise City of Hope has in early-phase development of leading-edge therapies for brain tumors,” Portnow said. “Our research portfolio has piloted multiple innovative strategies to fight brain cancer, including the use of neural stem cells that act as homing devices to deliver therapies directly to tumors in the brain.”

“I am delighted by the grant awarded to our collaborators at City of Hope for the treatment of recurrent brain tumors in adults. We believe our neural stem cell-mediated virotherapy has the potential to drive improved clinical outcomes for patients with high grade gliomas. Given NNV2’s ‘off-the-shelf’ nature, this therapy will be lower cost than autologous cell-based therapies and could be rapidly made available, bringing value to the healthcare system, and providing diverse patient populations access to treatment,” said Calidi Biotherapeutics CEO and Chairman of the Board Allan J. Camaisa. “We are pleased to receive the support of CIRM and the further endorsement of our NeuroNova platform and are excited for the continued advancement of this Phase 1 study with our partners at City of Hope.”

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 a 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 La Jolla, California. For more information, please visit www.calidibio.com.

Forward-Looking Statement

This press release may contain forward-looking statements and information relating to, among other things, Calidi Biotherapeutics and its business plan and strategy, and the highly competitive pharmaceutical industry. These forward-looking statements are based on the beliefs of, assumptions made by, and information currently available to the Company. When used in this press release, the words “estimate,” “project,” “believe,” “anticipate,” “intend,” “expect” as well as similar terms, are forward-looking in nature. These forward-looking statements involve a number of risks, uncertainties (many of which are beyond Calidi’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Calidi Biotherapeutics does not undertake any obligation to revise or update these forward-looking statements to reflect events or circumstances after such date or to reflect the occurrence of unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221213005212/en/