|
|
|
|
Protein Sciences Pursues Influenza Vaccines
|
Recent media interest in the swine flu (H1N1) has focused attention on Meriden-based Protein Sciences Corporation.
Founded in 1983, Protein Sciences is a privately held vaccine company. Its lead product candidates are vaccines to protect against seasonal and pandemic influenza.
The technology behind the company’s product candidates is its proprietary Baculovirus Expression Vector System (BEVS). The platform leverages a natural infection process of insect cells with an engineered baculovirus that specifically infects and re-programs the insect cells to produce the recombinant protein(s) desired. As a result, no live influenza viruses are needed for production of the Protein Sciences vaccines, and there are no egg proteins present in the products.
Furthermore, because the vaccine is highly purified, no
stabilizers (such as thimenosal (mercury derivative)) or
antibiotics are added.
The company received a $35 million contract last June from the U.S. Department of Health and Human Services to pursue
development of its flu vaccines. The contract could be extended for up to five years for a total value of approximately $147 million.
Influenza is a leading cause of illness and death around the world, resulting in an average of 220,000 hospitalizations and 36,000 deaths annually in the U.S. alone, according to the
CDC. New strains of influenza with pandemic potential are continually emerging (e.g.,
novel H1N1) and are associated with high mortality rates.
Protein Science’s vaccine pipeline includes FluBlok®, PanBlok™,
FluNhance™, and SARS (D3252).
FluBlok is Protein Sciences' seasonal influenza vaccine candidate. The company has conducted Phase 3 clinical studies for FluBlok. At this time a Biologics License Application (BLA) for commercialization of FluBlok is under review at the
FDA and the FDA is scheduled to decide on approval within a
few months. FluBlok comprises purified recombinant hemagglutinin antigens (active ingredient) and is formulated to contain 3X the active component as compared to
the licensed egg product flu vaccines.
PanBlok is Protein Sciences' pandemic influenza vaccine candidate. The current vaccine comprises purified recombinant hemagglutinin antigen (active ingredient) from the
H1N1 swine influenza. This product has attained Phase 2/3 clinical development through a partnership with UMN Pharma in
Japan, is completing clinical trials in Australia and
has received FDA approval for clinical trials in the U.S.
FluNhance is in development as a potential efficacy-enhancing additive to influenza vaccines through the addition of recombinant neuraminidase (rNA) to the vaccine formulation. Neuraminidase (NA) is another vaccine antigen target for
influenza; however, there are no other licensed vaccines standardized with a known amount of NA content. FluNhance has completed Phase II(b) challenge studies conducted by the National Institute of Allergy and Infectious Diseases
(NIAID) that demonstrated safety and reduction of virus shedding (virus spread) coupled with less severe and shorter duration of illness compared to the licensed vaccine alone.
Protein Sciences' Severe Acute Respiratory Syndrome (SARS) vaccine candidate (D3252) comprises purified recombinant Spike protein from the SARS virus. Preclinical studies have shown that immunization with D3252 that can elicit neutralizing antibodies (analogous to influenza). Protein Sciences is developing D3252 through a grant from
the NIAID. The product is anticipated to enter Phase I clinical trials in 2009.
In addition to developing its own pipeline of proprietary vaccine candidates, the company operates two additional business units: a product development and contract manufacturing service, GeneXpress®, whereby clients can access and leverage the company’s manufacturing technology and regulatory experience; and a line of
research products for the scientific community.
More at the company’s website, http://proteinsciences.com/
|
|
