Allogeneic mesenchymal stem cells loaded with oncolytic virus for cancer treatment

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Grant Award Details

Grant Type:

Late Stage Preclinical Projects

Grant Number:

CLIN1-14080

Investigator(s):

Name:

8587949607 Boris Minev

Institution:

Calidi Biotherapeutics, Inc.

Type:

Disease Focus:

Breast Cancer, Cancer, Melanoma, Solid Tumors

Human Stem Cell Use:

Somatic Cell

Award Value:

$3,111,467

Status:

Active

Progress Reports

Reporting Period:

Final Operational Milestone #5

CIRM PUBLIC SUMMARY

Project Title:

Allogeneic mesenchymal stem cells loaded with oncolytic virus for cancer treatment

Calidi Biotherapeutics has developed an innovative oncolytic virus therapy that uses viruses to kill cancer cells. Typically, the patient's immune system quickly eliminates these viruses, limiting their effectiveness. Calidi's platform combines these viruses with stem cells derived from fat tissue, protecting the viruses and allowing them to multiply at tumor sites. This leads to the death of cancer cells and triggers a strong anti-tumor immune response, both at the injected tumor site and distant metastatic sites.

The primary goal of this grant was to file an Investigational New Drug (IND) application to the FDA to support Calidi's upcoming clinical trial. This trial, titled "A Phase 1/2 Study of Intratumoral Administration of Allogeneic Mesenchymal Stem Cells Loaded with Oncolytic Vaccinia Virus in Patients with Advanced Metastatic Solid Tumors," aims to test this new cancer treatment in difficult-to-treat tumors.

The grant's first objective was to produce enough drug product to support the initial clinical trial. The final product was manufactured, tested, packaged, and labeled according to strict FDA guidelines. Additionally, Calidi conducted pre-clinical testing in laboratory settings and animal models to assess the drug's safety and effectiveness, which supported the IND application.

To prepare for the clinical trial, Calidi selected clinical trial sites and principal investigators, and prepared necessary documentation for the IND submission and trial initiation. The final step was electronically submitting the IND application, which was crucial for gaining approval to start the clinical trial.

Calidi’s upcoming clinical trial will focus on several types of cancer with significant unmet medical needs. The trial will be conducted in three parts: testing different doses, expanding the study to include more patients, and focusing on the cancer type that responds best to the treatment. This new therapy holds the promise of providing better treatment options for these hard-to-treat cancers.

Grant Application Details

Application Title:

Allogeneic mesenchymal stem cells loaded with oncolytic virus for cancer treatment

Public Abstract:

Therapeutic Candidate or Device

Supernova-1 (SNV1): Allogeneic adipose-derived culture expanded mesenchymal stem cells (AD-MSC) loaded with oncolytic vaccinia virus

Indication

-Metastatic melanoma
-Triple negative breast cancer
-Advanced Head & Neck Squamous Cell Carcinoma

Therapeutic Mechanism

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.

Project Objective

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

Statement of Benefit to California:

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.

Allogeneic mesenchymal stem cells loaded with oncolytic virus for cancer treatment

Grant Award Details

Progress Reports

Grant Application Details

Allogeneic mesenchymal stem cells loaded with oncolytic virus for cancer treatment

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