• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

GenVec Announces Additional Funding for Malaria Vaccine Program From the PATH Malaria Vaccine Initiative

Posted on: Tuesday, 1 May 2007, 09:00 CDT

GenVec, Inc. (Nasdaq:GNVC) announced today that the Company has amended and extended its existing Collaborative Research, Development and Supply Agreement with the PATH Malaria Vaccine Initiative (MVI). This Amendment includes up to $750,000 in additional funding through the end of 2007, to continue advancing a new multivalent malaria vaccine towards clinical evaluation.

This multivalent vaccine was developed under a multi-year Collaborative Research, Development and Supply Agreement with MVI currently worth up to $3.9M, for the production and evaluation of adenovirus vectors containing genes for up to five malaria antigens. Under a separate Collaborative Research and Development Agreement (CRADA) between GenVec and the Naval Medical Research Center (NMRC), NMRC scientists have provided GenVec with optimized malaria genes used in the adenovector vaccines and will perform pre-clinical evaluations. MVI has amended the original Agreement to provide sufficient funding for GenVec and its collaborator, NMRC, to complete the last steps in pre-clinical development prior to the production of cGMP materials that will be required for human clinical evaluation.

This multivalent vaccine contains the genes for up to five malaria antigens from different stages of the parasite's life cycle. Three of the antigens, circumsporozoite protein (CSP), liver stage antigen-1 (LSA1), and antigen 2 (Ag2) are expressed from a single adenovector and target the liver stage of the disease while two additional antigens, merozoite surface protein-1 (MSP1) and apical membrane antigen-1 (AMA1), are expressed from a second adenovector and target the blood stage of the disease; all are thought to be important in preventing or limiting the severity of malaria.

The multivalent design offers several potential advantages, including increased clinical efficacy and lower-cost production. Many malaria experts believe that a vaccine containing more than one malaria antigen (multivalent) will be necessary to adequately impact disease. Lower vaccine production costs will be of major importance to developing nations where malaria is prevalent.

"These novel vector designs enable us to produce a vaccine that targets five major malaria antigens, and we believe it can be produced cost-effectively," commented Joseph Bruder, Ph.D., GenVec's Director of Vector and Vaccine Programs. "The importance of these key advantages has been widely recognized by global malaria experts and we are grateful for the continued support and increased commitment of MVI."

"MVI is pleased with the work that has been carried out under the original Agreement with GenVec, and has decided to further support the partnership formed in 2004 between GenVec, NMRC and MVI," said Dr. Christian Loucq, Director of Strategy and Operations and Interim Director of MVI. "The pre-clinical studies supported by this partnership will provide additional information about the candidate vaccine best positioned to move forward. This information will allow MVI and the field to direct research and resources toward the most promising components for an effective malaria vaccine."

About Malaria

Malaria is one of the world's three leading infectious disease killers. Malaria is a life-threatening disease transmitted to humans through the bite of an infected mosquito. Malaria parasites initially invade liver cells and, after multiplying, release tens of thousands of new parasites, which invade red blood cells, multiply again, and then destroy these cells. High fever, headache and vomiting appear approximately nine to 14 days after the infectious bite. If untreated, the infection can progress rapidly and become life threatening, destroying red blood cells causing severe anemia and blocking capillaries that carry blood to the brain resulting in coma and death.

Malaria causes more than 300 million acute illnesses and more than one million deaths annually, mostly among children under the age of five. Malaria is also a major health risk for travelers and the military.

About PATH and the Malaria Vaccine Initiative

The PATH Malaria Vaccine Initiative (MVI) is a global program established through an initial grant from the Bill & Melinda Gates Foundation. MVI's mission is to accelerate the development of promising malaria vaccines and ensure their availability and accessibility for the developing world. MVI's vision is a world in which all children are safe from malaria. For information, visit http://www.malariavaccine.org. PATH is an international, non-profit organization that creates sustainable, culturally relevant solutions enabling communities worldwide to break longstanding cycles of poor health. For more information, please visit http://www.path.org.

About the U.S. Naval Medical Research Center

The Naval Medical Research Center (NMRC) conducts basic and applied research, development, and clinical evaluations to enhance the health, safety and readiness of Navy and Marine Corps personnel in the effective performance of peacetime and contingency missions. NMRC also provides research and development support as required by the Department of Defense. NMRC's Malaria Program is developing vaccines that prevent malaria infection in military personnel and for the humanitarian mission of providing access to malaria vaccines for those who need it most. Combining pioneering work on molecular vaccine technologies with cutting-edge genomics efforts, NMRC scientist's research efforts are focused on developing and testing "next generation" vaccine delivery systems to tackle one of the most complex vaccine challenges.

About GenVec

GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Each of the Company's product candidates uses patent-protected technology to deliver genes that produce beneficial proteins. GenVec's lead product, TNFerade™ is currently in a pivotal Phase II/III study (PACT) in locally advanced pancreatic cancer; Phase II studies are in progress in rectal cancer and melanoma; and Phase I/II studies are in progress in head and neck cancer. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, and seasonal and pandemic flu. Additional information about GenVec is available at www.genvec.com and in the Company's various filings with the Securities and Exchange Commission.

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future programs and studies, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or collaborators, risks relating to the commercialization, if any, of GenVec's proposed product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.

Source: Business Wire

More News in this Category