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.

P1, N=18, Recruiting, NYU Langone Health | Trial primary completion date: Nov 2025 --> Nov 2026 | Trial completion date: Nov 2025 --> Nov 2026

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

To our knowledge, this study is among the first to evaluate the combination of CpG7909 lipoplexes with anti-PD1 antibodies in the context of cancer immunotherapy. The findings suggest that this approach may convert the TME from an immunologically "cold" to "hot" state, thereby enhancing tumor suppression and potentially improving the response rate to ICIs.

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.

P1, N=140, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID)

P1/2, N=23, Terminated, TriSalus Life Sciences, Inc. | N=89 --> 23 | Active, not recruiting --> Terminated; The decision was made to terminate the study after the completion of Phase 1b enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.

P1, N=28, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2025 --> Dec 2025 | Trial primary completion date: May 2025 --> Dec 2025

P1, N=67, Terminated, TriSalus Life Sciences, Inc. | Active, not recruiting --> Terminated; The decision was made to terminate the study after the completion of Phase 1 enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.

Transgenic pigs (oncopigs) with liver tumors received intra-arterial infusions of fluorescently labeled ODN2395 or nelitolimod either via PEDD with a specialized infusion device or with conventional microcatheter delivery in both lobar and selective infusions. PEDD of nelitolimod significantly reduced immunosuppressive MDSCs and an increase in cytotoxic CD8 + T cells within the LM. In conclusion, use of PEDD enhanced targeted therapeutic delivery in swine liver tumors and reduced tumor progression by promoting anti-tumor immunity in murine LM in association with suppressive myeloid cell elimination.

P1, N=10, Recruiting, University of Maryland, Baltimore | Not yet recruiting --> Recruiting | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Oct 2025 --> Oct 2026

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