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

P1, N=10, Not yet recruiting, Northwell Health

To test the therapeutic applicability of STAT3 targeting, we utilized myeloid cell-selective STAT3 antisense oligonucleotide (CpG-STAT3ASO) to target neutrophils in vivo in tumor-bearing mice. Consistent with previous results, neutrophil-specific STAT3 knockdown impaired tumor growth and enhanced cytotoxic T cell activity in the tumors and tumor-draining lymph nodes of treated mice. These findings highlight STAT3 signaling as a deleterious pathway supporting the protumoral activity of neutrophils and suggest that neutrophil-targeted STAT3 inhibition is a promising opportunity for cancer immunotherapy, providing novel insights into targeted therapeutic avenues.