MVI-816

These results suggest that pTVG-HP may have had single-agent benefit that could not be appreciated using a MFS endpoint, challenging the notion that MFS can uniformly serve as a surrogate endpoint for overall survival in this stage of disease.

We previously reported a clinical trial (NCT02499835) evaluating PD-1 blockade combined with an anti-tumor DNA vaccine, pTVG-HP (encoding prostatic acid phosphatase), in patients with metastatic castration-resistant prostate cancer...These findings suggest that patients experiencing irAEs can have immune responses to tumor irrespective of obvious anti-tumor efficacy, at least with these treatments, and underscore the importance of tumor-infiltrating professional antigen presenting cells and T-cell activation for successful immunotherapy. Moreover, our findings suggest that combining vaccines and PD-1 blockade with MDSC-targeting therapies, anti-VISTA, and/or anti-PARP therapies might be further explored.

P1, N=14, Recruiting, University of Wisconsin, Madison | Not yet recruiting --> Recruiting

P1, N=14, Not yet recruiting, University of Wisconsin, Madison

The presence of T-cells specific for the PAP target antigen was detectable in 6/10 (60%) individuals with nmCSPC, and 3/5 (60%) individuals with nmCRPC, many years after immunization. The detection of immune responses to the vaccine target years after immunization suggests durable immunity can be elicited in patients using a DNA vaccine encoding a tumor-associated antigen.Trial Registration: NCT00582140 and NCT00849121.

P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Nov 2024 --> Dec 2027

P2, N=61, Active, not recruiting, University of Wisconsin, Madison | Recruiting --> Active, not recruiting

P2, N=60, Recruiting, University of Wisconsin, Madison | Trial completion date: Dec 2025 --> Oct 2026 | Trial primary completion date: Mar 2024 --> Jan 2025

In this population, combining nivolumab with pTVG-HP vaccination was safe, and immunologically active, prolonged the time to disease progression, but did not eradicate disease. Quantitative imaging suggested that additional treatments targeting mechanisms of resistance may be required to eliminate tumors.

P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Nov 2023 --> Nov 2024

P2, N=60, Recruiting, University of Wisconsin, Madison | Trial primary completion date: Dec 2023 --> Mar 2024

P1/2, N=66, Completed, University of Wisconsin, Madison | Active, not recruiting --> Completed