>>GAITHERSBURG, Md., Jan. 10 /PRNewswire/ -- GenVec, Inc. (Nasdaq: GNVC - news) announced today that it has signed a Letter Contract authorizing it to commence work for the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) using GenVec's proprietary adenovector technology for the development and manufacture of clinical grade preventative AIDS vaccine candidates. In addition, GenVec announced that in October 2001 it entered into a Cooperative Research and Development Agreement (CRADA) with the Vaccine Research Center.
The CRADA with NIAID governs a preclinical collaboration to evaluate and develop adenoviral vectors expressing modified HIV-1 genes. Each newly created adenovector will then be evaluated for potential application as an HIV preventative or therapeutic vaccine. This preclinical research project may lead to future opportunities for GenVec in the areas of technology transfer from the vaccine manufacturing and pre-commercialization manufacturing fields. While the CRADA itself does not generate revenue for GenVec, it does include built-in options to license new technology developed under the preclinical research project.
The Letter Contract, issued and managed on behalf of NIAID's Vaccine Research Center by SAIC Frederick, Inc. under the umbrella of a federally funded prime contract with NIH, authorizes GenVec to begin work now on a second adenovector project while the parties finalize a more complete contract that would have a life of up to three years (upon exercise of options) and a potential value of up to $10 million. The parties hope to finalize this contract by the end of January.
Under the preliminary contract and the proposed terms of the anticipated longer-term contract, GenVec is tasked with developing and manufacturing adenovector-based preventative AIDS vaccine candidates using its proprietary cell line and adenovector technology. GenVec will also work on developing an advanced, scaleable vaccine production process using manufacturing technologies developed at GenVec designed to support product commercialization.
``This is a new application of our adenovector technology in a very exciting area of medicine,'' said Dr. Imre Kovesdi, GenVec's Chief Scientific Officer. ``The AIDS vaccine candidates are based upon an emerging vaccine strategy which has performed extremely well in preclinical studies.''
Preclinical studies have suggested that using replication-deficient adenoviral vectors, such as those developed by GenVec, in a carefully crafted vaccine strategy can elicit potent and protective B-cell and T-cell immune responses that may control HIV-1 and other viral infections. The goal is to teach the body's immune system to recognize the HIV virus as an intruder so it can be eradicated and blocked from spreading throughout the body.
``Our adenovectors efficiently express the desired proteins within the human body, and have been safely administered to hundreds of people in our clinical trials in cardiovascular disease and cancer,'' stated Dr. Henrik Rasmussen, GenVec's Vice President of Clinical and Regulatory Affairs. Dr. Rasmussen continued, ``Because vaccines are designed to be administered to healthy people, the safety of the product is a key consideration. A safe, efficient gene delivery system could have extensive applications across a variety of human diseases and helps reduce hurdles in the development of gene- based drugs and vaccines.''
``GenVec was selected from a nationwide solicitation because of its leadership in adenovector technology. We are pleased to extend its use to new applications such as an AIDS vaccine. This alliance provides potential new product opportunities for GenVec and allows us to collaborate with leading researchers in an important new area of medicine,'' stated Dr. Paul H. Fischer, GenVec's President and Chief Executive Officer.
According to the Joint United Nations Programme on HIV/AIDS, as of the end of 2000, 36.1 million people were estimated to be living with HIV/AIDS worldwide. Since the beginning of the epidemic, over 21 million people have died as a result of infection with HIV/AIDS.<<
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