MVI-118 / Madison Vaccines - LARVOL DELTA

Phase 2 trial of pTVG-HP DNA vaccine, with or without pTVG-AR DNA vaccine, and pembrolizumab in patients with castration-resistant, metastatic prostate cancer (SITC 2025) - "Vaccines were provided by Madison Vaccines, Inc. Additional funding support was provided by the Prostate Cancer Foundation.Trial Registration Trial Registration: NCT04090528Ethics Approval This study was approved by the University of Wisconsin Health Sciences IRB, approval number 2018-0938."

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ACPP • PSAP

Phase 1/2 trial of androgen deprivation, with or without pTVG-AR, and with or without nivolumab, in patients with newly diagnosed, high-risk prostate cancer (SITC 2024) - P1/2 | "Methods 24 patients with high-risk prostate cancer planning to undergo prostatectomy were randomized to receive neoadjuvant treatment over 12 weeks with either androgen deprivation alone with degarelix (Arm 1, n=6), androgen deprivation with pTVG-AR (Arm 2, n=9), or androgen deprivation, pTVG-AR and nivolumab (Arm 3, n=9), according to the schema in (figure 1). The treatment arm with the most pathological responses will be expanded by an additional 15 patients to gain further information about safety and efficacy. Ethics Approval This study was approved by the University of Wisconsin Health Sciences IRB, approval number 2021-0575.Download figure Open in new tab Download powerpoint Abstract 1478 Figure 1 Study schema"

Clinical • Late-breaking abstract • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • CD4 • CTLA4 • LAG3

NCI-2019-07273: pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=61 | Active, not recruiting | Sponsor: University of Wisconsin, Madison | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Sequence of androgen receptor-targeted vaccination with androgen deprivation therapy affects anti-prostate tumor efficacy. (PubMed, J Immunother Cancer) - "Vaccination prior to ADT significantly improved antitumor responses, mediated in part by increased infiltration of CD8+T cells following ADT. Targeting MDSC recruitment following ADT further enhanced antitumor responses. These findings suggest logical directions for future clinical trials to improve the efficacy of prostate cancer vaccines."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • CD4 • CD8 • CXCR2

NCI-2019-07273: pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial completion date: Dec 2025 ➔ Oct 2026 | Trial primary completion date: Mar 2024 ➔ Jan 2025

Metastases • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: University of Wisconsin, Madison | N=39 ➔ 60 | Trial completion date: Apr 2025 ➔ Dec 2028 | Trial primary completion date: Apr 2025 ➔ Dec 2026

Checkpoint block • Checkpoint inhibition • Enrollment change • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8

NCI-2019-07273: pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial primary completion date: Dec 2023 ➔ Mar 2024

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Timing and sequencing of AR-specific vaccination combined with androgen deprivation therapy affect anti-tumor responses in murine prostate cancer models (SITC 2023) - "DNA vaccination consisted of the pTVG4 vector alone (control) or the DNA vector encoding the AR ligand binding domain (pTVG-AR) started either one day after tumor implantation, or one day following ADT...Depletion of MDSCs using clodronate liposomes significantly improved anti-tumor responses and increased infiltration of CD4+ and CD8+ T cells into prostate tumors. Since ADT causes accumulation of MDSCs within the tumors, current studies are investigating the intermittent use of ADT as an alternative to continuous treatment when combined with anti-tumor vaccination."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • CD4 • CD8 • IFNG

High-dose radiation is required for effective combination with tumor-specific vaccination in a prostate cancer model (SITC 2022) - "Background The approval of Sipuleucel-T demonstrates the value of antigen-specific vaccination approaches for prostate cancer...In this study, we evaluated whether TRT or external beam radiation therapy (EBRT) in combination with pTVG-AR could improve anti-tumor efficacy by increasing antigen-specific CD8+ T cell tumor infiltration in a murine prostate cancer model...Conclusions These data suggest that doses of RT in excess of 8 Gy, higher than what can be delivered by single treatment with 90 Y-NM600, may be necessary to optimally combine with antigen-specific vaccines in this model. Further work will explore the mechanism of this potential dose threshold."

IO biomarker • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • CD8 • PD-1 • PD-L1

pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor