RNA-NP vaccine / University of Florida - LARVOL DELTA

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: University of Florida | Suspended ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor • BRAF

Novel RNA-nanoparticle vaccine for the treatment of early melanoma recurrence following adjuvant anti-PD-1 antibody therapy. (ASCO 2024) - P1 | "Based on the tolerability and efficacy across subjects with both BRAF mutated and wildtype melanoma anti-PD1 (aPD1) therapy with either nivolumab or pembrolizumab are considered first line treatment in this setting. The goal of this study is to assess safety, tolerability, and feasibility of tumor specific RNA-LPs. Important biological correlates will also be collected and analyzed including tumor tissue sampling at initial time of checkpoint resistance and following vaccination series to identify key changes to the TME and tumor induced by lipid-nanoparticle vaccine administration."

Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • BRAF

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy (clinicaltrials.gov) - P1 | N=18 | Suspended | Sponsor: University of Florida | Recruiting ➔ Suspended

Trial suspension • Melanoma • Oncology • Solid Tumor • BRAF

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: University of Florida | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor • BRAF

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

Novel RNA-nanoparticle vaccine for the treatment of early melanoma recurrence following adjuvant anti-PD-1 antibody therapy (SITC 2023) - P1 | "In this study we propose the use of subject derived RNA-LP vaccine in patients who progress on, or soon after completion of adjuvant ICI. Secondary endpoints include overall response rate (ORR) and progression free survival rate (figure 5). Exploratory analysis will investigate the TME through single cell analysis pre and post vaccine series."

Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • LAMP1

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Trial completion date: Jul 2027 ➔ Sep 2026 | Trial primary completion date: Jul 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

Multilamellar mRNA lipid particles induce immunologic reprogramming in canine and human glioblastoma patients (SNO 2022) - P1 | "First-in-human application of systemic multilamellar RNA-NP vaccines results in significant biologic effects and rapid immunologic reprogramming."

Clinical • IO biomarker • Brain Cancer • Diffuse Midline Glioma • Glioblastoma • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor • CD8 • IL12A • IL6 • TLR7 • TNFA

RNA-nanoparticle vaccines overcome the immunosuppressive tumor microenvironment of metastatic osteosarcoma (SITC 2022) - P1 | "These vaccines bypass MHC restriction and can be made readily available for all patients/canines providing a renewable antigen resource that can be used to continuously vaccinate patients. This agent, which is FDA-IND approved (BB-19304, Sayour) and in human clinical trials for patients with brain tumors ( NCT04573140 ), may be a promising potential novel therapy for patients with recurrent pulmonary metastatic osteosarcoma."

Biomarker • IO biomarker • Tumor microenvironment • Brain Cancer • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • BATF3 • PTPRC

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Initiation date: Jan 2023 ➔ Jun 2023

Trial initiation date • Melanoma • Oncology • Solid Tumor • BRAF

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Initiation date: Oct 2022 ➔ Jan 2023

Trial initiation date • Melanoma • Oncology • Solid Tumor • BRAF

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Initiation date: May 2022 ➔ Oct 2022

Trial initiation date • Melanoma • Oncology • Solid Tumor • BRAF