Nantes, Lyon (France) and Atlanta (USA) –October 18th, 2011: VIVALIS (NYSE Euronext: VLS), and GeoVax Labs, Inc., (OTCQB/OTCBB: GOVX) announced that the two companies have entered into a biomanufacturing agreement to manufacture GMP-grade materials for the production of GeoVax’s MVA- based vaccines.
The VIVALIS-GeoVax collaboration, begun in 2008 and supported by a grant from the French innovation agency OSEO, addresses the manufacture of the MVA component of the GeoVax HIV/AIDS vaccine in the VIVALIS EB66® cell line. GeoVax and Vivalis have now entered into a supply agreement to produce master and working cell banks of EB66® cells for GeoVax, a first step leading to the production of clinical trial materials in VIVALIS’ GMP facility, owned and operated by VIVALIS since 2006. This facility has been approved by AFSSAPS, the French Agency for the Safety of Health Products, to produce investigational drug substances and products.
Robert McNally, Ph.D., GeoVax’s President and CEO stated, “We have been collaborating with Vivalis for a considerable period of time on the production of our MVA vaccine in the EB66® cell line. Currently, our MVA vaccine is grown in cells derived from embryonated chicken eggs. The EB66® cell line is a much more practical and cost-effective method to manufacture commercial-scale recombinant MVAs. The MVA vaccine is used in our preventative vaccine which is intended for use in uninfected people to prevent infection should they be exposed to HIV. It is also a component in our therapeutic vaccine for individuals already infected with HIV.”
Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS, commented, “We are very pleased to enter into this new agreement with GeoVax, an advanced company in the development of HIV vaccines. It is the third manufacturing agreement signed this year and represents approximately €4 million in total orders. After five new EB66® cell line agreements and three supply agreements this year, our integrated offer – which includes the EB66® cell line, process development, and GMP manufacturing –is highly valued by our clients in aiding their own product development. This new supply agreement with a US-based company further demonstrates VIVALIS’ capabilities to produce preclinical and clinical materials that fulfill American and European regulatory requirements.”
Financial terms of the program were not disclosed.
About GeoVax, Inc. (www.geovax.com)
GeoVax (OTCQB/OTCBB: GOVX) is a biotechnology company developing human vaccines to prevent and control HIV/AIDS infections. Our goals include developing HIV/AIDS vaccines for global markets, overseeing the manufacture and testing of these vaccines under GMP/GLP conditions (FDA guidelines), conducting clinical trials for vaccine safety and effectiveness, and obtaining regulatory approvals to move the product forward. GeoVax's vaccines are unique in expressing virus like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. All preventative Phase 1 human clinical trials have been conducted by the US Government sponsored HIV Vaccine Trial Network. A phase 1 trial tested various combinations and doses of our DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from Phase 1 testing supported the initiation of Phase 2 testing which has successfully enrolled 299 participants at 11 trial sites in the United States and South America. GeoVax is currently enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV.
About the EB66® cell line
The EB66® cell line, derived from duck embryonic stem cells, presents unique industrial and regulatory characteristics, such as long-term genetic stability, immortality, short population doubling time (< 18h) and cell growth up to high cell densities in suspension in a serum-free medium (>50 millions cells/mL).
The BMF (Biologics Master File) for the registration of the EB66® cell line with the FDA (U.S. Food and Drug Administration) was filed on June, 2008. Two EB66® based vaccines are currently in clinical trial in United States and in Japan.
The EB66® cells replicate a wide range of human and animal viruses and are currently used or being evaluated for the production of viral vaccines, virosomes and virus-like-particles by the major players in the vaccine field.
The EB66® cells are easily genetically engineered to efficiently express recombinant proteins of interest (> 1 g/L). Monoclonal antibodies produced in EB66® cells have human-like glycosylation profile, with the remarkable additional feature of having reduced fucose content. This latter characteristic provides a better cytotoxic activity to antibodies, particularly useful in the treatment of cancer cells.
About VIVALIS (www.vivalis.com)
VIVALIS (NYSE- Euronext: VLS) is a biopharmaceutical company that provides innovative cell-based solutions to the pharmaceutical industry for the manufacture of vaccines and proteins, and develops drugs for the prevention and treatment of unmet medical needs. VIVALIS' expertise and intellectual property are leveraged in three main areas:
1. EB66® Cell Line
VIVALIS offers research and commercial licenses for its EB66® cell line, derived from duck embryonic stem cells, to pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, VLP’s, and recombinant proteins (with a focus on monoclonal antibodies having enhanced cytotoxic activity). EB66® cell line based vaccines are currently in clinical trials in USA and in Japan. Through these programs VIVALIS receives upfront, clinical stage milestone payments along with royalties on licensees’ net sales.
2. VIVA|ScreenTM Human Antibody Discovery Platform
Customized solutions for the discovery, development, and production of fully human monoclonal antibodies are now offered by VIVALIS. Through these programs VIVALIS receives upfront, clinical stage milestone payments along with royalties on licensees’ net sales.
3. 3D-ScreenTM Drug Discovery Platform
VIVALIS performs discovery and development, up to pre-clinical evaluation, of original small chemical molecules identified with its proprietary platform, 3D-ScreenTM. This unique screening platform is designed to identify original molecules that alter the three-dimensional structure of a target protein, thus modulating its biological function through an innovative mode of action. VIVALIS is building a portfolio of proprietary new chemical entities for the treatment of hepatitis-C virus infection. VIVALIS also proposes, on a fee for service basis, to develop ready to use customized 3D- ScreenTM HTS assays directed against client’s target protein of interest.
Based in Nantes & Lyon (France) and in Toyama (Japan) VIVALIS was founded in 1999 by the Grimaud Group (ca. 1,500 employees), a worldwide leader in animal genetic selection. VIVALIS has established more than 30 partnerships and licenses with world leaders in this sector, including Sanofi Pasteur, GlaxoSmithKline, Transgene, Pfizer Animal Health, Kaketsuken, Kitasato Daiichi Sankyo Vaccine, Merial, Merck Animal Health, SAFC Biosciences. VIVALIS is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bioclusters and a member of the Japanese OKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in Toyama.
Media contact for GeoVax Labs in the US.
The Investor Relations Group