Ozmosi | Vidutolimod Drug Profile
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Vidutolimod

Alternative Names: vidutolimod, cmp-001, cmp001, cmp 001, cyt-003, cyt003, cyt 003, cyt003-qbg10, cyt003qbg10, cyt003 qbg10
Clinical Status: Inactive
Latest Update: 2026-02-17
Latest Update Note: Clinical Trial Update

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: Eastern America
Company Founding Year: 1988
Additional Commercial Interests: Kuros

Clinical Description

Map of Global Clinical Trials for Vidutolimod

Countries in Clinic: France, United States

Active Clinical Trial Count: 3

Recent & Upcoming Milestones

  • Clinical Outcomes Reported - Regeneron presented P2 Melanoma results on 2025-06-03 for Vidutolimod

Highest Development Phases

Phase 2: Basal Cell Carcinoma|Carcinoma, Merkel Cell|Cutaneous Squamous Cell Carcinoma|Lymphoma|Melanoma|Non-Small-Cell Lung Cancer|Squamous Cell Carcinoma|Triple Negative Breast Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT03983668

NCT03983668

P2

Completed

Lymphoma

2024-08-23

69%

2025-08-27

Primary Endpoints

NCT04401995

HCC 20-049

P2

Completed

Melanoma

2024-08-16

28%

2024-10-22

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

2023-507344-36-01

CMP-001-009

P2

Completed

Squamous Cell Carcinoma|Non-Small-Cell Lung Cancer|Basal Cell Carcinoma|Cutaneous Squamous Cell Carcinoma|Carcinoma, Merkel Cell|Triple Negative Breast Cancer

2024-06-14

33%

2025-05-02

Treatments