Madison Vaccines Announces Program Expansions For Its Investigational Prostate Cancer Vaccines

New Sites Added to Phase 2 Clinical Trial of Madison Vaccines’ MVI-816 for Pre-Metastatic Prostate Cancer, Plans Move Ahead for Combination Trial with PD-1 Inhibitor

FDA Approves Application for MVI-118 to Begin Clinical Trials for Advanced Prostate Cancer

Company Secures Additional Series A Financing to Fund Expanded Projects

MADISON, Wis.--(BUSINESS WIRE)--Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company focused on advancing innovative therapies for prostate cancer, today announced that plans are progressing for three projects in early, advanced and late-stage prostate cancer.

“We believe our products can make a meaningful difference in treating this disease, and we are pleased to have the expertise of Douglas McNeel, MD, PhD, our Scientific Co-Founder, and a leading prostate cancer researcher at the University of Wisconsin-Madison.”

• Two additional sites have opened enrollment for the Phase 2 clinical trial for MVI’s lead product-candidate, MVI-816, in non-metastatic prostate cancer;
• The company has selected, and will procure a PD-1 inhibitor for a combination trial with MVI-816 in late-stage prostate cancer;
• The FDA has approved a Phase 1 IND (Investigational New Drug) application for MVI-118, MVI’s new vaccine to address treatment resistance and disease progression in advanced prostate cancer.

To fund these projects, MVI has increased its Series A financing to $11 million with its current syndicate of investors.

“MVI is now uniquely positioned with our product-candidates in three distinct stages of prostate cancer from pre-metastatic, to the start of metastases, to late-stage, castrate-resistant disease,” said Richard Lesniewski, PhD, President of MVI. “We believe our products can make a meaningful difference in treating this disease, and we are pleased to have the expertise of Douglas McNeel, MD, PhD, our Scientific Co-Founder, and a leading prostate cancer researcher at the University of Wisconsin-Madison.”

The Phase 2 clinical trial of MVI-816 in non-metastatic prostate cancer is now expanding to include The Johns Hopkins University and the University of California, San Francisco. MVI-816 is for patients with rapidly rising PSA after their initial treatment. These are patients with the highest risk of developing bone or other metastases after their initial prostate cancer therapy. Currently, their options are to just watch and wait, a risky decision, or to move ahead with surgical or chemical castration (Androgen Deprivation Therapy or ADT).

MVI-816 will also be paired with a PD-1 pathway inhibitor designed to expose the cancer cells to attack by preventing the cancer cells from camouflaging themselves. Pairing the PD-1 inhibitor with MVI-816 to stimulate the immune system may allow the one-two punch to be effective in late-stage disease. The trial will be conducted with an award from the Prostate Cancer Foundation through the Movember Challenge program, and will be conducted under Dr. McNeel’s direction.

MVI-118, a second vaccine being developed by MVI, targets the human androgen receptor, the critical biological target responsible for driving prostate cancer progression and, in many cases, resistance to current therapies. The FDA approved the IND application in late January 2015, and the University of Wisconsin-Madison is finalizing preparations for the Phase 1 trial to begin.

Both MVI-816 and MVI-118 are plasmid DNA vaccines, which differ from other vaccines because they can be rapidly and inexpensively manufactured, there are no problems with solubility, and DNA vaccines are relatively more stable in storage.

About MVI

Wisconsin-based MVI is developing two plasmid DNA vaccines to treat men with prostate cancer. MVI-816 (pTVG-HP) is designed to activate patients’ immune systems to kill prostate cancer cells after initial treatment but before incurable metastases develop in skeletal bone. MVI-118 (pTVG-AR) is a second DNA vaccine being developed that targets the human androgen receptor, the critical biological target that in many cases is responsible for resistance to current therapies. MVI has licensed patented technologies that were developed in the laboratory of Dr. Douglas McNeel at the University of Wisconsin-Madison. More information is available at www.madisonvaccines.com.