CpG 1018-adjuvanted mRNA vaccine induced transient body weight loss (<6%) with an overall good safety. Our data warrant further investigation of CpG 1018-adjuvanted neoantigen mRNA vaccine for potentially better tumor therapy.

P1, N=26, Completed, Universitätsklinikum Hamburg-Eppendorf | Recruiting --> Completed | Trial primary completion date: Feb 2026 --> May 2026

P1, N=140, Active, not recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting --> Active, not recruiting

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

Correlation analyses suggested that IFNα, TNF, and IL-6 were key for CPG7909-induced LNR-cDC activation, whereas R848's effect appeared more cytokine-independent. We conclude that combining locally delivered CPG7909 and R848 in early-stage melanoma will ensure full-range DC subset activation and robust pro-inflammatory T-cell responses in melanoma SLN, independent of sex.

P2, N=100, Recruiting, Pulmotect, Inc. | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: Apr 2026 --> Apr 2027

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.

P1, N=28, Terminated, M.D. Anderson Cancer Center | Active, not recruiting --> Terminated; <75% participation

P1, N=10, Recruiting, Northwell Health | Not yet recruiting --> Recruiting

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.

P1/2, N=11, Active, not recruiting, University of California, San Francisco | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026

Here, we developed a novel whole-cell vaccine, termed MDLSD, by combining mitoxantrone (MTX)-induced ICD with the TLR9 agonist SD-101. Furthermore, mice cured by MDLSD developed long-term immunological memory, characterized by a recall response dominated by IFN-γ+ CD8+ and TNF-α+ T cells, enabling rejection of secondary tumor challenges. Collectively, our findings illustrate that the MDLSD vaccine synergizes the antigenic breadth of ICD with potent TLR9 stimulation to elicit robust DC activation, polyfunctional T-cell responses, and durable immunological memory, offering a compelling strategy for cancer immunotherapy.