Oncopore (ruxotemitide)

P2, N=23, Completed, Lytix Biopharma AS | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jul 2025

Here, oncolytic STING-activating microgels (OSAM) that release oncolytic peptide LTX-315 and STING adjuvant diABZI in a sustained manner (>4 weeks) have been developed to elicit long-acting and powerful antitumor immunity...One single intratumoral administration of OSAM markedly promoted the infiltration of cytotoxic T lymphocytes and natural killer cells, which combining with anti-CTLA-4 microgels afforded exceptional therapeutic benefits in several different murine tumor models with a cure rate of 40%-71%. These oncolytic STING-activating microgels introduce a new and powerful strategy to in situ cancer vaccines.

After combination therapy, significant increases in CD8+ T cells, CD8+/IFN-γ+ T cells, CD8+/TNF-α+ T cells, and natural killer cells, along with a decrease in Tregs, were observed in tumors (p < 0.001). RFH significantly enhanced the effects of LTX-315 on orthotopic HCC by activating the cGAS-STING pathway.

To overcome these limitations, we developed an injectable thermosensitive hydrogel (LC-Gel) that incorporates the oncolytic peptide LTX-315 and the chemokine CCL21 to generate in situ DC vaccines aimed at enhancing anti-tumor immunity...Moreover, LC-Gel is shown to trigger long-term immune memory for eliciting a distant anti-tumor effect. In summary, our study introduces an innovative in situ DC vaccination strategy using an injectable oncolytic hydrogel platform for cancer immunotherapy.

Overall, the results of this study demonstrated that LTX-315 plus anti-CTLA-4 antibody could synergistically improve the immunosuppressive microenvironment of residual tumors and induce a strong anti-tumor immunity after iRFA of HCC. This combination treatment strategy may offer a new alternative to reduce the tumor recurrence after RFA of malignant solid tumors with large sizes or in high-risk locations.

P2, N=27, Recruiting, Oslo University Hospital | Not yet recruiting --> Recruiting

P2, N=27, Not yet recruiting, Oslo University Hospital

P2, N=92, Completed, Verrica Pharmaceuticals Inc. | Recruiting --> Completed

The TSRP is composed of: i) Recognition unit could specifically target and inhibit the biological function of FGFR-1; ii) Transformable unit could self-assembly and trigger nanofibers formation; iii) Reactive unit could specifically cleaved by MMP-2/9 in tumor micro-environment; iv) Immune unit, stimulate the release of immune cells when LTX-315 (Immune-associated oncolytic peptide) exposed...All above processes together contribute to the increasing survival rate of tumor-bearing mice by nearly 4-folds. This work presented a unique design for the biological application of one-step synergistic therapy of bladder cancer.

Critically, the effects of LTX-315 on DCs the consequent promotion of anti-melanoma immunity depend on the cytosolic signal transducer myeloid differentiation response gene 88 (MyD88). These results cast light on the mechanisms by which LTX-315 induces DC maturation and hence elicits anticancer immunity, with important implications for the use of LTX-315 as an anticancer immunotherapeutic.

P2, N=20, Active, not recruiting, Lytix Biopharma AS | Recruiting --> Active, not recruiting

Intratumoral RFA-associated RFH could enhance the efficacy of immunochemotherapy of LTX-315 with liposomal doxorubicin for HCC, which may provide a new strategy to increase the curative efficacy of thermal ablation for medium-to-large HCC.