The grant will go towards 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 $12m 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.
Early signs of efficacy
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,” explained Boris Minev, M.D., President, Medical and Scientific Affairs of Calidi Biotherapeutics.
High-grade gliomas
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 use 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.
Calidi holds an exclusive worldwide licensing agreement for patents covering the NSC-CRAd-S-pk7 technology (NeuroNova).