Full Press Release Details
| GEOVAX | VIVALIS | |
| Media Contact: Melanie Nimrodi | Media Contact: Steve Grobet/Emmanuel Huynh | |
| 1 312.546.3508 | 33 (0) 1 44 71 94 91 | |
| mnimrodi@frbir.com | vivalis@newcap.fr | |
| Company Contact: | Company Contact: | |
| Robert McNally / Jennifer Nelms | Franck Grimaud | |
| 1 404.727.0971 | investors@vivalis.com |
GeoVax Partners with VIVALIS for Use of its Revolutionary EBx Technology to
Manufacture its MVA HIV/AIDS Vaccine
Partnership creates worldwide strategic collaboration between Vivalis and GeoVax
ATLANTA (GA USA) NANTES (France) July 22, 2008 GeoVax Labs, Inc. (OTC BB: GOVX), an
Atlanta based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1
(Human Immunodeficiency Virus) and other infectious agents, together with VIVALIS (NYSE Euronext
:VLS), a French biopharmaceutical company that provides innovative cell-based solutions to the
pharmaceutical industry for the manufacture of vaccines and proteins, announced today the signing
of a letter of intent (LOI) for joint collaboration and commercial license on the use of Vivalis
EBx technology, to manufacture the MVA component of the GeoVax HIV-1 vaccine.
This agreement between GeoVax and Vivalis creates a worldwide strategic partnership between Vivalis
and GeoVax, designed to combine Vivalis cutting-edge vaccine manufacturing technology with
GeoVax s promising HIV vaccine.
The breakthrough manufacturing technology developed by Vivalis, and now to be further developed
through collaboration with GeoVax, will create a new standard for manufacture of the MVA component
of the GeoVax HIV/AIDS vaccine, making present manufacturing technologies which have limited
production capabilities, less competitive. Vivalis EBx manufacturing platform, with
its increased effectiveness, superior quality and reliability, will speed time to market MVA
vaccine product availability in ample quantities to meet sizeable demand and expectedly at a lesser
Partnering with Vivalis and its cutting-edge technology is extremely significant, and a giant step
forward for efficient manufacturing of our MVA HIV/AIDS vaccine component, stated Robert
McNally, President and CEO, GeoVax.
VIVALIS is pleased to enter in this collaboration with GeoVax, one of the most advanced companies
worldwide in the field of HIV vaccine development. This agreement aims at developing a VIVALIS
proprietary upstream-downstream process for the production of MVA vaccines and EBx
technology licensing. GeoVax becomes a strategic partner and joins an elite worldwide consortium in
the field of development, purification and production of MVA based vaccines, said Franck Grimaud,
The EB66 cell line is becoming a new standard for the production of vaccines, leading
to Vivalis having signed more than 20 licenses prior to December 2007 and four licenses in 2008:
two research and two commercial.
Vivalis vaccine manufacturing technology is based on a duck embryonic stem cell substrate
platform. The EB66 cell line provides continuous growth from a fully characterized
frozen cell bank, without necessitating fertilized embryo extraction and processing, as with
present chicken cell based technologies. Furthermore, the EB66 cell line can be grown
in suspension (without the cells attached to the surface of the growth vessel) and
for growth in giant bioreactors (a cutting edge industrial method) for large scale production of
the MVA viral vaccine.
Last month, Vivalis announced the filing of the BMF (Biologics Master File) for the
EB66 cell line with the US FDA (Food and Drug Administration). Extensive testing
reveals the unique and innovative nature of Vivalis EBx technology for the production
of vaccines and proteins. Today, the EB66 cell line is the only available
cell line in the market to be immortal and diploid.
When we learned about the work of Vivalis with EBx cell lines that might be able to be
used to grow MVA, we contacted Vivalis and arranged with them to jointly conduct pilot studies on
the growth of our MVA vaccine, said Harriet Robinson, Senior Vice President of Research and
Development, GeoVax. Our early production results have been very promising and have led to this
LOI for more formal development of the Vivalis EB66 cell line for the production of our
The GeoVax vaccine is a DNA/MVA vaccine that uses recombinant DNA to prime the immune response and
then a recombinant MVA virus to boost the immune response. MVA stands for Modified Vaccinia Ankara,
a smallpox viral vaccine that was attenuated (made more safe) by replicating the vaccine virus over
500 times in chicken cells. This long series of replications resulted in a derivative of the
smallpox vaccine virus which could grow in chicken cells but that had limited ability to grow in
human cells. The poor ability to grow on human cells has made MVA a very safe vaccine vector for
humans. However, it also limited the ability to manufacture MVA in the industrial cell lines that
have been approved for vaccine production. Rather, MVA had to be grown in chicken cells which rely
on harvesting cells from thousands of chicken embryos and using these cells which are grown in
multiple small vessels for vaccine manufacture. This process can be done for clinical and
commercial production, but is cumbersome, fraught by the introduction of contaminants and
expensive. The Vivalis EBx manufacturing technology eliminates such difficulties and
enables rapid large scale production in bioreactors for GeoVax s future commercial needs.
Financial terms of the agreement have not been disclosed. However, each side shall fund its roles
respectively, depending on developmental or process responsibilities assumed by each party. An
upfront amount payable to Vivalis will be provided as consideration for the signing of the LOI.
GeoVax s development and license payments shall be made based on milestone achievements. Royalties
on GeoVax net sales are also included. In addition, applications have been filed for EU and local
government financial participation. GeoVax is also seeking FDA guidance on the Vivalis
EBx manufacturing program recently submitted to the USA FDA allowing usage of
EB66 produced MVA vaccine for GeoVax s ongoing human trials.
Earlier this month, GeoVax also announced an operational update on the company s progress towards
entering Phase 2 preventative human clinical trial testing and plans to proceed into therapeutic
human trials with its AIDS vaccine. The Company s Phase 2 trial, to be conducted by the U.S.
National Institutes of Health (NIH) and supported HIV Vaccine Trials Network (HVTN), will involve
225 healthy volunteers from the United States and South America, and will further evaluate the
safety and immunogenicity of the GeoVax preventative vaccine (vaccine administered prior to
infection with the AIDS virus). The GeoVax DNA/MVA vaccine uses a different viral vector (MVA) than
the Merck vaccine and the NIH Vaccine Research Center vaccines, which use adenovirus5 (Ad5)
vectors. The Merck vaccine was withdrawn from trials in September 2007 because of failure to
protect. The NIH has just announced that their vaccine will not be progressing in large scale
trials because of the Merck results. Thus two major competitors for GeoVax are no longer
progressing in trials.
About GeoVax Labs, Inc.
GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and
commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other
infectious agents. GeoVax s HIV/AIDS vaccine technology is the subject of 20 issued or filed patent
applications. GeoVax HIV/AIDS vaccines are designed for use in uninfected people to prevent
Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should the person
ever become infected. GeoVax HIV/AIDS
vaccines also may be effective as therapeutics (treatment of
people already infected with AIDS virus). Studies evaluating these vaccines in HIV/AIDS infected
individuals are in the planning stage.
GeoVax s core HIV/AIDS vaccine technologies were developed through a collaboration of colleagues at
Emory University s Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease
Control and Prevention (CDC) and the GeoVax team.
GeoVax HIV/AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine
Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative
agreement with the National Institutes of Health NIH), is the largest worldwide clinical trials
program dedicated to the development and testing of HIV/AIDS vaccines. Preclinical work enabling
evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided
additional support to GeoVax AIDS vaccine development program with a $15 million IPCAVD grant