GeoVax Labs Inc (GOVX)

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GeoVax Labs, Inc. : Vivalis and GeoVax Enter into a Biomanufacturing Agreement for the Production of MVA-Based Vaccines for HIV
http://www.4-traders.com/GEOVAX-LABS-INC-194639/news/GEOVAX-LABS-INC-Vivalis-and-GeoVax-Enter-into-a-Biomanufacturing-Agreement-for-the-Production-of-MVA-13846159/
Press releaseVIVALIS AND GEOVAX ENTER INTO A BIOMANUFACTURING AGREEMENT FOR THE PRODUCTION OF MVA-BASED VACCINES FOR HIVNantes, 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 mliilon 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.

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Next financial press release: 2011 third-quarter salesOctober 20, 2011, after NYSE Euronext market closing
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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.

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