MicroVAX Cancer Vaccine First in Human Clinical Trial in Singapore

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MicroVAX, LLC, National Cancer Center (NCC), Singapore, and Singapore Clinical Research Institute (SCRI) joint media release, August 12, 2014

MicroVAX, LLC, a biotech company located in Manassas, Virginia announced today the commencement of a phase I clinical trial for its unique and proprietary vaccine platform that allows under the provisions of an FDA IND entry of patients with cancers of the breast, prostate, colon, ovary and lung, that have relapsed after initial salvage therapy. The trial is sponsored by the Singapore Clinical Research Institute (SCRI), and conducted by Dr Toh Han Chong, Senior Consultant and Deputy Director at the National Cancer Centre Singapore (NCCS). “Our main objective is to assess the safety and benefit of this unique vaccine, which aims to target a common protein on many of the commonest cancers such as colon cancer, breast cancer and ovarian cancer, and provide a specific extra boost to the immune system against cancer at the same time. We will also assess how potent this vaccine can stimulate a meaningful immune response against the cancers.” When fully implemented, the MicroVAX vaccine is designed to both destroy pre-existing cancerous tumors and prevent cancer. NCCS also obtained a research grant for SGD $800,000 from National Medical Research Council, Singapore for support of the evaluation of the immune response induced by the vaccination of subjects in the clinical trial.

Jake Frank, managing member of MicroVAX said, "MicroVAX is delighted to be partnering with Dr. Toh Han Chong and his world class team of clinical cancer immunologists from the National Cancer Center Singapore, and the Singapore Clinical Research Institute on the initial clinical testing of its cancer vaccine." The MicroVAX cancer vaccine is comprised of the attachment of the target protein MUC-1, expressed on the surface of the cancers mentioned, to the potent immune stimulating molecule CD40L. This novel combination aims to further power up the body’s full immune system to attack the surface cancer protein, MUC1, thereby killing the cancer cells themselves. Pre-clinical testing, the results of which were reported in the Journal of Immunology, showed that the MUC-1/CD40L vaccine can overcome states of immune unresponsiveness (anergy), induce an immune memory response, and induce complete shrinkage of pre-existing cancers which are progressing. The vaccine platform concept was initiated at Yale University and was later supported by grants from the Breast Cancer Research Foundation, the Department of Defense, and the Sidney Kimmel Foundation for Cancer Research. In addition to applying the TAA/ecdCD40L vaccine platform to several types of cancer, MicroVAX is studying the vaccine platform for application to several infectious diseases.

“This trial showcases the strong partnership between an Academic Research Organization like SCRI with a biotech company like MicroVAX and a prestigious healthcare institution like National Cancer Centre Singapore (NCCS) in conducting new clinical trials in Singapore. It is also the first time SCRI embarks on sponsoring clinical trial to support the clinical trial community in Singapore”, said Dr Teoh Yee Leong, CEO, SCRI.

For enquiries to participate in the trial, please contact our clinical research coordinator Ms Chong Hui Shan at 6436- 8431 or chong(dot)hui(dot)shan(at)nccs(dot)com(dot)sg

For more information, please contact:

MicroVAX: Jacob Frank, (703) 475-5332, email: jacob(dot)frank(at)snyderllp(dot)com
National Cancer Centre Singapore: Edwin Yong, 6236-9465, email: edwin(dot)yong(dot)c(dot)y(at)nccs(dot)com(dot)sg
Singapore Clinical Research Institute: Widia Huang, email: widia(dot)huang(at)scri(dot)edu(dot)sg

About MicroVAX LLC

MicroVAX is a clinical stage biotech company located in Manassas, Prince William County, VA, dedicated to the development of potent vaccines, for treatment and preventive purposes, having application to the areas of cancer and infectious diseases for which effective solutions have not yet been developed. “As a member of the growing life sciences community in Prince William County and as a part of the George Mason University Enterprise Center, MicroVAX is ideally situated in the heart of a well-established research ecosystem with close proximity to key federal institutions, which have been and will continue to be instrumental as our R&D leads towards future FDA regulated clinical trials,” said Jake Frank managing member of MicroVAX.

About National Cancer Centre Singapore

National Cancer Centre Singapore (NCCS) provides a holistic and multidisciplinary approach to cancer treatment and patient care. We treat almost 70 per cent of the public sector oncology cases, and they are benefiting from the sub-specialization of our clinical oncologists. NCCS is also accredited by the US-based Joint Commission International for its quality patient care and safety.

To deliver among the best in cancer treatment and care, our clinicians work closely with our scientists who conduct robust cutting-edge clinical and translational research programmes which have been internationally recognised. NCCS strives to be a global leading cancer center, and shares its expertise and knowledge by offering training to local and overseas medical professionals.

About the Singapore Clinical Research Institute (SCRI)

The Singapore Clinical Research Institute (SCRI), a subsidiary of Ministry of Health Holdings is an Academic Research Organization with the strategic imperative to enhance the standards of human clinical research through driving the development of core capabilities, infrastructure, intellectual and scientific leadership in Singapore. Its vision is to develop SCRI and Singapore as an ASEAN hub for clinical research excellence.

This release includes forward-looking statements concerning a Phase I trial of the MicroVAX investigational vaccine, including with respect to expectations related to clinical outcomes. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: timely submission and approval of anticipated regulatory filings; clinical results validating the use of the vaccine to treat patients with severe cancer indications; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities. MicroVAX does not undertake to update its forward-looking statements.

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Jacob Frank
+1 (703) 475-5332
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