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NIAID awards vaccine contracts

By Katrina Megget, 09-Aug-2007

Related topics: Materials & Formulation, Ingredients, excipients and raw materials

Two US life sciences companies have been awarded contracts from the National Institutes of Allergy and Infectious Diseases (NIAID) to develop vaccines.

Meridian Bioscience and Dynavax Technologies both received separate vaccine development deals worth $12.2m and $3.25m respectively.

Meridian Bioscience's five-year contract would see the company manufacturing up to 10 clinical experimental non-influenza and influenza virus vaccines per year at its Memphis biopharmaceutical facility.

The contract would require the production and safety testing of the vaccines and other vaccine-related products for use in humans.

The undisclosed suspensions of viruses being manufactured have been shown in previous studies to be promising candidates for developing vaccines for humans.

Meridian will also develop wild-type virus suspensions for challenge studies to evaluate effectiveness of immunoprophylaxis (the prevention of disease by the production of active or passive immunity) or in pathogenesis studies and manufacture Master Cell Lines under the terms of the contract for use in the production of viruses or for other uses as directed by the NIAID.

The company would work with the Laboratory of Infectious Diseases (LID).

Parent company Meridian Life Science president Richard Eberly said in a statement: "We are pleased to continue our collaboration with the NIH to include the production of viral vaccines and challenge materials for use in human clinical studies."

"Being selected for this program is consistent with our core strengths in cell culture, virology, and immunology and demonstrates out commitment to high quality manufacturing of clinical biologics. Through collaboration with the LID of the NIAID/ National Institutes of Health, we are hopeful that many of these experimental vaccines will ultimately be used for the prevention of viral diseases in humans."

Dynavax's two-year contract would see the company continuing the development of a novel universal influenza vaccine for controlling seasonal and emerging pandemic flu strains.

The initial research was funded by the National Institutes of Health, starting in 2003, and focuses on a new vaccine that incorporates a second-generation Toll-like receptor 9 (TLR9) agonist, a class of agents that induce a specific immune response, and the conserved influenza antigen nucleoprotein (NP), the antigen for a major internal virion structural protein.

Dynavax vice president of preclinical research Dr Gary Van Nest said in a statement: "The grant is another important endorsement of our approach. We believe that NP represents a unique vaccine component that when conjugated to our second generation TLR9 agonist can address the limitations of seasonal flu vaccines as well as represent an important advance in the development of a universal vaccine to protect against a pandemic flu outbreak."

Studies in mice have shown that the vaccine can provide a strong, cross-strain protective immunity.

Other animal model studies have also found that the vaccine can be used in conjunction with standard vaccine to enhance immunogenicity and provide dose sparing of traditional flu vaccine components.

Beside NP, Dynavax is also using another conserved influenza antigen, the extracellular domain of matrix protein 2 (M2e). When this is linked to a second-generation TLR9 agonist it generates a broadly reactive antibody response against influenza.

"Immune responses against both NP and M2e conjugates have the ability to kill virus infected cells that evade the protection provided by the standard vaccine. This is key when seasonal flu vaccines do not match the flu strains that emerge each year or especially if a completely new pandemic strain emerges," Van Nest said.

The company plans to move into clinical development in 2008.

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