GeoVax Announces Clinical Development License Agreement with Valneva SE

Use of Valneva's EB66(R) Cell Line to Aid in Development of Commercial-Scale Manufacturing Process for GeoVax's HIV/AIDS Vaccine

ATLANTA, GA, / ACCESSWIRE / August 6, 2014 / GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing HIV/AIDS vaccines, today announced that it has signed a clinical development license agreement with European biotechnology company Valneva SE, to develop MVA-based vaccines in Valneva's EB66(R) vaccine production cell line.

The deal broadens the collaboration between the two companies which have been working together since 2008 to generate a process for manufacturing the MVA (modified vaccinia Ankara) component of GeoVax's HIV/AIDS combination vaccine using Valneva's EB66(R) cell line technology. The new agreement will allow GeoVax to enter clinical trials with a candidate vaccine derived from EB66(R) cells and also permits the transfer of the cell line to a third party GMP manufacturer. Financial terms of the agreement were not disclosed.
"We are very pleased to have entered into this agreement with Valneva as it takes us another step forward toward developing a low-cost HIV vaccine suitable for the developing world," said Robert McNally, PhD, GeoVax's President and CEO. "As we continue development of our HIV vaccine constructs for the clade C subtype of HIV that afflicts countries in sub-Saharan Africa and other developing nations, our intention will be to utilize the EB66(R) production method to produce vaccine product for our clinical trials."
HIV has a number of major subtypes (or clades) that are endemic to various geographic areas of the globe. GeoVax's current clinical trials for prevention and therapeutic use of its vaccines are specific for clade B which is the major subtype of HIV for the Americas, Western Europe, Australia and Japan. GeoVax has the leading vaccine candidate for prevention of clade B HIV infection and is poised to begin Phase 2b human efficacy trials. But the greatest number of HIV infections occur in Sub-Saharan Africa (primarily clade C), accounting for two-thirds of the world's total. In that region, 23.5 million people are currently infected with HIV and every year there are 1.8 million new infections.
GeoVax is developing a DNA/MVA vaccine against clade C infections and intends to use the EB66(R) cell line as a means to reduce the manufacturing cost of the MVA boosting vaccine component. Reducing the manufacturing cost is critical to the development pathway for a vaccine to serve the developing world. The agreement with Valneva allows GeoVax to proceed with, and accelerate, its planning for human clinical trials for the clade C version of its HIV/AIDS vaccine.
About GeoVax
GeoVax Labs, Inc. (OTCQB: GOVX) is a biotechnology company developing vaccines to prevent, and treat, Human Immunodeficiency Virus (HIV) infections. GeoVax's unique, two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV antibody and anti-HIV T cell immune responses. GeoVax's DNA and MVA vaccines are used in a prime/boost protocol in which priming is done with the DNA and boosting with the MVA. Both the DNA and MVA express the three major proteins of the HIV virus: Gag, Pol, and Env, and produce non-infectious virus-like-particles. GeoVax's vaccines are unique in expressing virus-like particles that display the native form of the trimeric membrane-bound HIV-1 envelope glycoprotein. GeoVax's vaccines are currently being tested in human clinical trials, for both preventive and therapeutic applications. Clinical trials for GeoVax's preventive HIV vaccines have been conducted by the US National Institutes of Health-supported HIV Vaccine Trials Network (HVTN) with funding from the National Institute of Allergy and Infectious Disease (NIAID). Overall, GeoVax's vaccines, in various doses and combinations, have been tested in close to 500 humans.
About the EB66(R) Cell Line
Valneva's EB66(R) cell line is a highly efficient platform for vaccine production. It is derived from duck embryonic stem cells and today represents a compelling alternative to the use of chicken eggs for large scale manufacturing of human and veterinary vaccines. To date, Valneva has more than 35 research and commercial agreements with the world's largest pharmaceutical companies to utilize its EB66(R) technology. The first human vaccine using EB66(R) technology received marketing approval in 2014 and the first veterinary vaccine in 2012.
About Valneva
Valneva SE is a European biotech company focused on vaccine development and antibody discovery. It was formed in 2013 through the merger of Intercell AG and Vivalis SA. Valneva's mission is to excel in both antibody discovery, and vaccine development and commercialization, either through in-house programs or in collaboration with industrial partners using innovative technologies developed by the company. Valneva generates diversified revenue from both its marketed product, a vaccine for the prevention of Japanese encephalitis (IXIARO(R)), commercial partnerships around a portfolio of product candidates (in-house and partnered), and licensed technology platforms (EB66(R) cell line, VIVA|Screen(R) antibody discovery technology, and the IC31(R) adjuvant) developed by Valneva that are becoming widely adopted by the biopharmaceutical industry worldwide. Headquartered in Lyon, France, the company employs approximately 300 people in France, Austria, Scotland, the United States, and Japan.
Forward-Looking Statements
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent HIV/AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.
Adam S. Holdsworth
ProActive Capital Group