Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company focused on advancing innovative therapies for prostate cancer, today announced an initial close of an $8 million Series A financing. The round was led by Venture Investors, LLC, and joined by Wisconsin Alumni Research Foundation (WARF), Venture Management, LLC (VM), the State of Wisconsin Investment Board (SWIB), and others. The proceeds will support ongoing development of MVI's pipeline, including completion of an expanded Phase 2 clinical trial for MVI-816 in non-metastatic prostate cancer patients with rapidly rising PSA, before the need for surgical or chemical castration (androgen deprivation therapy or ADT). These are patients with the highest risk of developing bone or other metastases after their initial prostate cancer therapy.

MVI-816 is a DNA vaccine, called a plasmid DNA vaccine because human genetic material is produced in small pieces of circular bacterial DNA known as plasmids, which are purified and used to genetically induce an immune response to the cancer. Plasmid DNA vaccines have several advantages compared to protein or peptide vaccines: DNA can be rapidly and inexpensively purified, there are no problems with solubility, and DNA vaccines are relatively more stable in storage. MVI-816 targets prostatic acid phosphatase (PAP), a well-defined prostate antigen suitable for prostate vaccines.

'Our goal in developing MVI-816 is to significantly delay both the onset of metastases and the initiation of ADT for these patients,' said Richard Lesniewski, PhD, President of MVI. 'This $8 million financing will allow MVI to advance our efforts to establish a safe and approvable immune activation therapy for men with early malignant prostate cancer.'

Patients with PSA-recurrent prostate cancer currently face two options: to watch and wait (and worry) while their PSA continues to rise after their initial surgery or radiation, or to start some form of castration therapy, and expose themselves to the significant decline in quality of life associated with this type of hormonal deprivation. MVI-816 is intended to provide a third option to take action against the cancer without the need for castration.

'The Series A financing of MVI is important because it enables us to advance our work with MVI-816 beyond our basic research and previously completed Phase 1 studies, through proof-of-concept in early stage patients,' added Douglas McNeel, MD, PhD, Professor of Medicine at the University of Wisconsin-Madison, and Scientific Co-Founder of MVI.

MVI-118 is a second DNA vaccine being developed by MVI. This vaccine targets the human androgen receptor, the critical biological target responsible for driving prostate cancer progression and, in many cases, resistance to current therapies.

Dr. McNeel highlighted the importance of the Series A financing to also advancing MVI-118, stating, 'MVI is now well-positioned to support completion of both preclinical and Phase 1 safety studies which are critical to enable future efficacy studies of MVI-118 as monotherapy, and in combination with standard ADT therapies, in early metastatic disease.'

'MVI represents an exciting investment opportunity that facilitates clinical Phase 2 proof-of-concept studies for MVI-816 in a very capital-efficient manner,' stated Paul Weiss, PhD, Managing Director at Venture Investors. 'With an experienced biopharmaceutical team, and the support of other local investors, including WARF, VM, and SWIB, this financing will also allow the company to take MVI-118 through an initial Phase 1 clinical trial in prostate cancer patients.'

About MVI-816

MVI-816 is currently being evaluated in a randomized, double-blinded, placebo-controlled Phase 2 clinical trial in men with PSA-recurrent prostate cancer who are not being treated with testosterone-lowering therapies, who do not have evidence of metastases by imaging, and whose PSA doubling times are ‰¤ 12 months. MVI-816 was shown to be safe in a Phase 1 trial, and elicited antigen-specific CD8+ cytotoxic T-cell responses. Also observed were biochemical changes (slowing of PSA doubling times) in > 30% of Phase 1 patients. The current Phase 2 trial will measure metastasis free survival at 24 months and changes in median time to disease progression.

About MVI

The principal mission of Madison, Wisconsin-based MVI is the development of therapeutic plasmid DNA vaccine products for patients with prostate cancer. MVI is also developing a sensitivity test to identify those patients who will derive clinical benefit from these vaccines. MVI has licensed patented technologies from WARF, which were developed in the laboratory of Dr. Douglas McNeel at the University of Wisconsin-Madison. More information is available at www.madisonvaccines.com.