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MVI Vaccine to be Used in Clinical Trial of a New Combination Approach to Immunotherapy Funded by The Prostate Cancer Foundation and The Movember Foundation

--Trial Pairs MVI-816 with a PD-1 Pathway Inhibitor to Treat Metastatic Prostate Cancer--

--Prostate Cancer Foundation/Movember Foundation Award Goes to the University of Wisconsin to Conduct the Clinical Trial--

Madison, WI, August 27, 2014 – Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company, today said its lead product candidate MVI-816 (pTVG-HP) will be used in a clinical trial testing a two-pronged immunotherapy approach 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.

For more information about the Prostate Cancer Foundation, go to www.pcf.org.

For more information about the Movember Foundation, go to www.movember.com.

 

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 to the 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.

 

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Madison Vaccines Incorporated Announces Expansion of a Phase 2 Clinical Trial for MVI-816, its Lead DNA Vaccine for Prostate Cancer

--MVI-816 Intended to Delay Metastatic Disease after Primary Therapy, but Before Hormonal Therapy--

--Trial Now Enrolling at University of Wisconsin, with Additional Centers to Follow--

Madison, WI, June 23, 2014 – Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company, today announced enrollment has begun in the expansion of a Phase 2 clinical trial of its lead product candidate MVI-816 (pTVG-HP). The expansion will add 50 patients to the original cohort of 56 patients to produce more robust results. The trial is enrolling non-metastatic prostate cancer patients who have rising PSA after their primary treatment (surgery or radiation), but before patients require androgen deprivation therapy (castration therapy). The trial is seeking clinical evidence that MVI-816 can delay the onset of metastatic disease in these patients. The trial is funded by the company, with patient recruitment currently underway at the University of Wisconsin, and future enrollment anticipated at the University of California San Francisco and at least one other site later this year.

“Our goal is to help men with recurrent prostate cancer live longer with a better quality of life,” said Richard Lesniewski, PhD, President of MVI. “The expansion of this Phase 2 trial represents a significant step forward for our young company and advances our efforts to establish clinical proof of concept toward a safe and approvable immune activation therapy for men with prostate cancer at this crucial stage of their disease.”

MVI-816 targets prostatic acid phosphatase (PAP), a well-defined prostate antigen. 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 compared to protein or peptide vaccines. MVI is also developing a second vaccine for men with early metastatic disease, to help prolong the duration of disease control they receive from current androgen deprivation therapies.

 

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 that were developed in the laboratory of Dr. Douglas McNeel at the University of Wisconsin-Madison.  More information is available at www.madisonvaccines.com.

 

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Madison Vaccines Announces the Appointment of Michael Richman to its Board of Directors

--Extensive Research and Business Experience will Support Development of New Treatment Options for Prostate Cancer--

Madison, WI, May 14, 2014 – Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company focused on advancing innovative therapies for prostate cancer, today announced the appointment of Michael Richman to its Board of Directors. Mr. Richman has almost 30 years’ experience working in pharmaceutical research and business development. He helped found Amplimmune, a spinout from Johns Hopkins University, and has since overseen the acquisition of the company by MedImmune, the global biologics research and development arm of AstraZeneca, as a part of their global commitment to immunotherapy and developing novel medicines for patients.

“Michael has an extensive record working in the immune therapy space, possesses highly effective business development acumen, and has seasoned biotech management and governance skills,” said Richard Lesniewski, Ph.D., President of MVI. “We are developing DNA vaccines for prostate cancer patients who might otherwise face castration. Michael’s guidance will be invaluable as we work to extend the quality and length of life for men with recurrent disease.”

Mr. Richman has held positions in companies including Chiron Corporation (now Novartis), MacroGenics and MedImmune, Inc. (now Astra Zeneca), where he was Senior Vice President Corporate Development. While at MedImmune, Mr. Richman drove over $1.6 billion in transactions. He has now come full circle with Amplimmune now being part of MedImmune. Mr. Richman obtained his B.S. in Genetics/Molecular Biology at the University of California at Davis and his M.S.B.A. in International Business at San Francisco State University.

 

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 that were developed in the laboratory of Dr. Douglas McNeel at the University of Wisconsin-Madison.  More information is available at www.madisonvaccines.com.

 

Madison Vaccines Closes $8 Million Series A Financing

Proceeds will Support Clinical Development of Two Promising Prostate Cancer Vaccines

Madison, WI, January 13, 2014 – 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.