vidutolimod (CMP-001)

In situ immunization with Vidutolimod, a virus-like particle containing a CpG-A TLR9 agonist, has demonstrated anti-tumor activity in pre-clinical and early phase clinical studies, however its effect on tumor-specific CD8⁺ T cells remain poorly defined...Together, these findings demonstrate Vidu treatment expands the number of intratumoral and circulating tumor-specific CD8⁺ T cells, and that the number of tumor specific CD8+ T cells and the anti-tumor response is sustained by the addition of αPD-1. These results support continued evaluation of Vidu as a cancer immunotherapeutic agent, including in combination with immune checkpoint blockade.

These findings indicate BDCA2 plays a dual role in the immune response to Vidu, with the amount of anti-Qb antibody coating Vidu determining whether interaction of Vidu with BDCA2 results in pDC activation or inhibition. This important mechanistic information could influence the design of the next generation of pDC-targeting immunotherapeutic nanoparticles.

In summary, endosomal TLRa VLPs all have the ability to activate pDCs, however, combined TLR7/8 activation using TLR7/8a VLPs was significantly more effective than the other VLPs at activating T cells and was dependent on direct contact with pDCs. Therefore, TLR7/8a VLPs may potentially induce a robust anti-tumor immune response and warrant further investigation for cancer therapy.

P2, N=10, Suspended, Emory University | Trial completion date: Jun 2027 --> Jun 2028

Vidutolimod PS20-A alone or in combination with pembrolizumab had an acceptable safety profile and promising clinical activity in patients with PD-1 blockade-resistant melanoma.

P1, N=199, Completed, Regeneron Pharmaceuticals | Phase classification: P1b --> P1

ELISA revealed significantly elevated levels of IFN-γ, IL-12, and TNF-α in the sera of mice after 24 h of one treatment with vidutolimod + ICB as well as increased levels of proliferating T cells and pDCs in draining lymph nodes 72 h after the third and final treatment, thus indicating the immune-boosting effect of this therapy. Vidutolimod + ICB caused a significant decrease in Ki-67 expression by epithelial cells in the lesion area compared to untreated mice, implicating that this treatment regime may prevent lesion progression.

P2, N=60, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026

P2, N=40, Active, not recruiting, Centre Hospitalier Universitaire Vaudois | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Sep 2023 --> Dec 2025 | Recruiting --> Active, not recruiting

P2, N=60, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting

P1/2, N=39, Active, not recruiting, Umar Farooq | Trial primary completion date: Apr 2025 --> Aug 2024

P1/2, N=39, Active, not recruiting, Umar Farooq | Suspended --> Active, not recruiting