Profile: Novavax Inc (NVAX.O)
20 Dec 2013
Novavax, Inc. (Novavax), incorporated in 1987, is a clinical stage biopharmaceutical company. The Company focuses on developing recombinant vaccines. The Company’s technology platform is based on recombinant vaccine technology that includes the virus-like particles (VLPs). The Company's vaccine candidates are genetically engineered three-dimensional nanostructures, which incorporate immunologically important recombinant proteins. In July 2013, Novavax acquired approximately 97.4% of shares in Isconova AB.
The Company's product pipeline focuses on a variety of infectious diseases and the Company's vaccine candidates have completed clinical trials that target pandemic influenza (H5N1), seasonal influenza and respiratory syncytial virus (RSV). The Company’s joint venture, CPL Biologics Private Limited, develops a rabies vaccine candidate that is genetically engineered by Novavax. CPL Biologics Private Limited completed initial pre-clinical immunogenicity studies on this new vaccine candidate and is progressing with pre-clinical toxicology studies.
The Company conducted a Phase II trial of its H1N1 VLP vaccine candidate in Mexico in collaboration with Laboratorio Avi-Mex S.A. de C.V. and GE Healthcare. It has produced a first batch of non-cGMP influenza A (H1N1) VLP vaccine candidate. It reported that a single administration of the VLP vaccine induced high levels of hemagglutinin inhibition (HAI) titers in subjects without pre-existing detectable immunity to H1N1 influenza. The Company’s influenza VLPs contains three of the structural influenza virus proteins, which contains hemagglutinin (HA) and neuraminidase (NA), both of which stimulates the body to produce antibodies that neutralize the influenza virus and prevent its spread through the cells in the respiratory tract, and matrix 1 (M1), which stimulates cytotoxic T lymphocytes to kill cells that may already be infected.
Novavax's insect cell culture based platform production technology, combined with single-use bioprocessing technology is employed throughout the manufacturing process. In February 2011, the Company was awarded a contract from the Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS BARDA) of the United States government for the first 36 month base-period, with an HHS BARDA option period of 24 months.
The Company focuses on launching two Phase I trials of its H5N1 vaccine candidate in combination with several alternative adjuvant candidates. These trials will evaluate the safety and tolerability of the vaccines in the presence and absence of adjuvants; the ability of VLP vaccine antigens with and without adjuvants to generate antibody levels that fulfill the Food and Drug Administration's (FDA) criteria for accelerated approval and the ability of these vaccines to provide an expanded number of doses and possible cross-protection against other virus strains to the United States population.
The Company had initiated a seasonal influenza Phase II dose-ranging trial using both trivalent and quadrivalent (four strain) formulations. The Company developed a quadrivalent formulation of its seasonal influenza vaccine candidate as many influenza vaccine manufacturers move from trivalent to quadrivalent formulations.
The Company has developed a recombinant nanoparticle vaccine for the prevention of RSV. In pre-clinical studies, the Company has demonstrated positive results in models designed to test the safety and efficacy of its RSV vaccine candidate. The Company announced favorable results from an RSV pre-clinical study performed in mice against the viral fusion (F) protein, which fuses with cells in the respiratory tract and causes illness. The vaccine induced neutralizing antibodies against the viral fusion protein and also protected against RSV infection. It announced positive pre-clinical results with a recombinant RSV fusion (F) particle vaccine in cotton rats.
The Company’s vaccine technology platform is based on VLPs, which are self-assembling protein structures that resemble viruses. VLPs closely mimic natural virus particles with repeating protein structures that can elicit broad and strong antibody and cellular immune responses, but lack the genetic material required for replication. VLP technology is employed in marketed products, such as Merck’s Gardasil. The influenza VLPs contains components, which provides immune response. The VLPs contain the viral components hemagglutinin (HA), neuraminidase (NA) and matrix protein (M1). In February 2011, the Company entered into a licensing agreement with LG Life Sciences, Ltd. (LGLS) that allows LGLS to use its VLP technology to develop and commercially sell its influenza vaccines in South Korea and certain other emerging-market countries.
The approved influenza vaccines are produced by growing virus in chicken eggs, from which the virus is extracted and further processed. In addition, sometimes the influenza virus strain must be changed in order for it to be produced efficiently in the egg. The production process involves the use of genetic information and no viral seed is required. Novavax produces VLPs using a baculovirus expression system in insect cells with disposable low cost equipment, which could be readily dispersed both nationally and internationally.
The company competes with Sanofi Pasteur, Inc., MedImmune, LLC, GlaxoSmithKline plc, Novartis, Inc. and Merck & Co., Inc.
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