Pre-clinical Data On Recent Advances With HIV VLP Vaccine Presented At AIDS Vaccine 07 Conference
Commenting on the presentation, Dr. Rahul Singhvi, president and CEO of Novavax said, "The data presented today demonstrate that immunization with VLPs containing a consensus envelope protein is a promising approach to achieving the desired broadly neutralizing antibody response against the HIV-1 virus. These data also substantiate the promise of our recombinant VLP technology to design vaccines to ultimately generate an immune response that can prevent complex diseases such as HIV/AIDS."
Virus-like particles (VLPs) represent an attractive HIV-1 vaccine platform for a safe and effective vaccine against HIV/AIDS. VLPs have the potential to mimic the three-dimensional structure of a virus without the risk of replication or infection. Applications of the VLP technology have been limited in the past due to very low level incorporation of HIV-1 envelope glycoprotein, the principal target for neutralizing antibody responses, into the HIV-1 virus or recombinant VLPs. Scientists from Emory University and UAB, working closely with Novavax scientists reported last week how to genetically modify the HIV-1 envelope to significantly increase the content of envelope protein that is anchored to particles (Wang, et al., J Virol Online, Sept 1, 2007).
In addition to increasing the level of envelope protein in VLPs, the composition of envelope was modified to make it broadly reactive against several HIV strains. Genetic variation is a hallmark of HIV-1 infection and a major obstacle to HIV vaccine development. Scientists contributing to the current study designed centralized (ancestral and consensus) HIV-1 envelope constructs to help induce cross-reactive immune responses. One of these consensus HIV-1 envelope genes was used to generate the HIV-1 VLPs reported in this study.
In today's presentation, Dr. Liu described that in preclinical studies, VLP vaccination after DNA priming induced HIV-1 neutralizing antibodies to tier 1 viruses that are easy to neutralize and to a select number of tier 2 viruses that are much harder to neutralize. The tier 2 viruses include HIV-1 subtype B viruses, which are common in Europe, Australia, and the Americas, and subtype C viruses, which are predominant in southern Africa, China, and India. HIV-1 subtype B and C viruses account for more than 50% of AIDS worldwide. The study also demonstrated that HIV-1 VLPs formulated without an adjuvant were as potent as an adjuvanted protein subunit vaccine with respect to eliciting neutralizing antibody responses to both tier 1 and tier 2 viruses.
Dr. Richard Compans, chairman of the department of microbiology and immunology, Emory University School of Medicine, and senior investigator on the research team, said, "This vaccine approach differs from most others now in clinical trials in that VLPs are designed to produce neutralizing antibodies. Such antibodies have the potential to block the HIV infection process at its earliest stage."
Dr. Beatrice Hahn, professor of medicine at the University of Alabama at Birmingham, added "VLPs represent an exciting new vaccine delivery platform for HIV, the full potential of which has not yet been realized."
Novavax will support its collaborators in completing pre clinical studies of the consensus envelope HIV-1 VLP candidate vaccine over the next 12 - 18 months and human clinical trials could begin as early as 2009.
Novavax is developing vaccines to prevent influenza, HIV and other viral diseases leveraging its proprietary VLP vaccine technology. The company is conducting a Phase I/IIa clinical trial of a pre-pandemic influenza VLP vaccine.
About Novavax
Novavax Inc. (Nasdaq: NVAX) is a clinical-stage vaccine company committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventives options. Using the company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.
Forward-Looking Statements
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, safety, efficacy and potency of our vaccines, and supply availability are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax 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 and uncertainties, including the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to commencing clinical trials and their outcome; risks relating to the supply and commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, 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 Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.
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