Grant Award Details
- To achieve an active IND for SV1, adipose derived allogeneic MSC bearing oncolytic CAL-1 virus. Activities include completion of IND enabling studies of GMP manufacturing, GLP and non GLP pharm/tox studies and IND submission.
Grant Application Details
- Allogeneic mesenchymal stem cells loaded with oncolytic virus for cancer treatment
Therapeutic Candidate or Device
Supernova-1 (SNV1): Allogeneic adipose-derived culture expanded mesenchymal stem cells (AD-MSC) loaded with oncolytic vaccinia virus
-Triple negative breast cancer
-Advanced Head & Neck Squamous Cell Carcinoma
SNV1 will induce direct killing of cancer cells and will modify the tumor microenvironment, converting immunologically "cold" umors into "hot" tumors.
Calidi's final product contains not only stem cells loaded with viral particles, but also immune modulatory cytokines produced by the stem cells as well as virally encoded proteins. Therefore, the tumor microenvironment is modified immediately upon intro-tumoral injection to support effective viral amplification and killing of the cancer cells.
Unmet Medical Need
The proposal's targeted indications are associated with significant morbidity with limited treatment options and poor survival rates. Our new treatment approach will contribute to the effective treatment and improving quality of life of these patients.
Completed product manufacturing & IND application
Major Proposed Activities
- Manufacturing of the final therapeutic drug product
- Development and validation of assays for analysis of patient samples
- IND-enabling animal model studies and electronic submission of the IND application to the FDA
The proposed research will benefit significantly the State of California and its citizens as this novel cancer treatment approach will address the unmet clinical needs of the three targeted indications by improving the standard of care and patients' quality of life and by providing cost-effective treatment options, especially in underserved patient populations. SNV1 can become a valuable product for the California's healthcare system due to its practical application as an off-the-shelf product.