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Madison begins dosing in prostate cancer trial of MVI-816 and pembrolizumab combination

US-based Madison Vaccines Incorporated (MVI) has started dosing in a clinical trial of its lead prostate cancer vaccine MVI-816 (pTVG-HP) in combination with pembrolizumab (Keytruda), a PD-1 inhibitor.

PD-1 inhibitor, also called a checkpoint inhibitor, works by exposing cancer cells to attack by the immune system by preventing the cancer cells from blocking an effective immune response.

Currently, MVI-816 is in a Phase II clinical trial as monotherapy and has been shown to induce persistent T-cell responses in prostate cancer patients.

The combination trial will examine the hypothesis that both treatments work together synergistically.

The trial will be conducted at the University of Wisconsin, Carbone Cancer Center under the direction of Douglas McNeel, a leading prostate cancer researcher at the university.

MVI president Richard Lesniewski said: "Immunomodulatory drugs such as PD-1 inhibitors made headlines again at this year’s global ASCO cancer conference. However, in prostate cancer, they have failed to produce a clinical response.

"We believe this trial may show that combining a PD-1 inhibitor with our MVI-816 vaccine will unleash the potential of immunomodulators in patients in the late stages of this disease."

MVI-816, a plasmid DNA vaccine delivered by intradermal injection, targets prostatic acid phosphatase (PAP), a well-defined prostate antigen.

Currently, MVI-816 is in a Phase II clinical trial in patients with early biochemically recurrent prostate cancer to delay the onset of metastatic disease after primary therapy.

The company also intends to start a trial for its second prostate cancer vaccine, MVI-118, a vaccine targeting the androgen receptor intended to address treatment resistance and disease progression in metastatic prostate cancer.