Madison Vaccines’ MVI-816 to be used in clinical trial of a new combination to treat metastatic prostate cancer

The vaccine is intended to stimulate the immune system to fight the cancer cells while a PD-1 pathway inhibitor is designed to prevent the cancer cells from camouflaging themselves to expose the cancer cells to attack.

The trial will be conducted with a $1.5 million 2014 Movember-Prostate Cancer Foundation (PCF) Challenge Award funded by the Movember Foundation and supported by the Movember-PCF Challenge Award program. The research will be conducted under the direction of Douglas McNeel, M.D., Ph.D., Professor of Medicine at the University of Wisconsin-Madison.

"This is important validation for our young company, to have our lead vaccine selected as part of a competitive grant by the leading philanthropic organization funding and accelerating prostate cancer research globally," said Richard Lesniewski, Ph.D., President of MVI. "This trial supplements MVI’s current clinical strategies, and may advance the timetable for demonstrating clinical efficacy of our lead vaccine."

MVI-816 targets prostatic acid phosphatase (PAP), a well-defined prostate antigen, and is currently in development to delay the onset of metastatic disease after primary therapy. It is a plasmid DNA vaccine that can be delivered to patients by simple intradermal injection, is readily manufactured in a cost-effective manner, and is highly stable.

"This award represents a 1.5 million dollar commitment to the potential of immunotherapy," said Dr. McNeel. "While PD-1 inhibitors have worked well in certain cancers, they have not been as successful in treating metastatic prostate cancer. We believe this two-pronged immune activation approach, pairing a PD-1 pathway inhibitor with a vaccine, will generate the results we need to have a significant impact on this disease."

Jonathan W. Simons, M.D., President and CEO, Prostate Cancer Foundation, said, "Our Foundation has opened doors for a whole new generation of cancer vaccines such as Dr. McNeel’s new biotechnology. Our partnership with Movember has been pivotal in making new cancer vaccine research possible."

Mark Hedstrom, US Country Director for Movember, added, "Together with PCF, the Movember Foundation is committed to having an everlasting impact on the face of men’s health, and with projects like this, working towards a world where no man will die from prostate cancer."

Discussions are underway to determine which PD-1 pathway inhibitor will be used in the trial. Patient enrollment is expected to begin within the next year. Separately, a company-sponsored Phase 2 clinical trial of MVI-816 in early stage prostate cancer is currently underway.