Product Description
Vidutolimod is an immune activator that stimulates T cells to attack tumors. It is a non-infectious, biologic virus-like particle (VLP) containing CpG-A DNA. Vidutolimod works by two complementary mechanisms that together have a unique ability to drive a strong systemic anti-tumor T cell response. First, the VLP activates an immune response to the VLP, leading to the production of antibodies that deliver the VLP into plasmacytoid dendritic cells (pDC) and other immune cells via specialized receptors called FcR . This provides an initial stimulatory signal to pDC and brings the CpG-A to TLR9 (the receptor for CpG DNA) inside the (pDC). Second, CpG-A stimulates TLR9 in a manner that induces significantly higher levels of type I interferons (IFN-alpha and others) in pDC resulting in a stronger anti-tumor T cell response, as compared to other innate immune activators. (Sourced from: https://checkmatepharma.com/our-science/vidutolimod-platform-technology/
Mechanisms of Action: Vaccine,TLR9
Novel Mechanism: Yes
Modality: Vaccine
Route of Administration: Subcutaneous
FDA Designation: Fast Track - Melanoma *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Regeneron
Company Location: TARRYTOWN NY 10591
Company CEO: Leonard S. Schleifer
Additonal Commercial Interests: Kuros
Clinical Description
Countries in Clinic: Australia, France, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Melanoma
Phase 2: Basal Cell Carcinoma|Carcinoma, Merkel Cell|Head and Neck Cancer|Lymphoma|Non-Small-Cell Lung Cancer|Squamous Cell Carcinoma|Triple Negative Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
HCC 20-049 | P2 |
Active, not recruiting |
Melanoma |
2028-07-30 |
|
NCT03983668 | P2 |
Suspended |
Lymphoma |
2025-04-01 |
|
CMP-001-009 | P2 |
Active, not recruiting |
Carcinoma, Merkel Cell|Basal Cell Carcinoma|Triple Negative Breast Cancer|Non-Small-Cell Lung Cancer|Squamous Cell Carcinoma |
2024-10-31 |
|
CMP-001-011 | P3 |
Completed |
Melanoma |
2024-07-22 |