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Vaccines

We apply our proprietary BEVS platform technology to produce the next generation of vaccines for the prevention and treatment of a wide range of diseases.

Our lead product candidates are vaccines for protection against seasonal and pandemic influenza. Influenza is a leading cause of illness and death around the world. It results, on average, in more than 200,000 hospitalizations and 3,000 to 49,000 deaths annually in the U.S. alone. New strains of influenza of pandemic potential are continually emerging (e.g., H1N1) and can be associated with high mortality rates (>70%).

An independent market study (Datamonitor, 2007) found that the worldwide influenza vaccine market is growing rapidly and is predicted to more than double in size to more than $4.4 billion by 2016. We have established a broad patent estate on influenza vaccines produced using recombinant technology in our expresSF+ cells.



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Panblok

Panblok is our pandemic influenza vaccine candidate.

The vaccine is comprised of purified recombinant hemagglutinin antigens from influenza viruses that have the potential to cause pandemics, such as the H1N1 swine and H5N1 and H7N9 avian influenza viruses. Future formulations can rapidly be adapted to protect against any emerging pandemic strain.

Phase I clinical trials with Panblok have been completed in the U.S. and Australia, and Phase II clinical development is underway in Japan through a partnership with UMN Pharma, which is now partnered with Astellas. The data suggest that Panblok is safe and that administration of Panblok can prime people for enhanced immune responses upon subsequent vaccination (learn more here).

Panblok Advantages:

Underlying manufacturing technology provides ability for a specific and rapid response to a pandemic strain emergence

Priming response has been demonstrated

No influenza viruses used in production

No antibiotics or preservatives (e.g., thimerosal)

Adjuvanted formulation results in significant dose sparing

No egg-related byproducts

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FluNhance

FluNhance is patented worldwide and is in development as a potential efficacy-enhancing additive to influenza vaccines. It is comprised of recombinant neuraminidase (rNA) and can be added to any vaccine formulation.

Neuraminidase, like hemagglutinin, is a protein expressed on the surface of influenza viruses that is strain-specific (for example, the N1 in H1N1). Such specificity makes NA a promising target for influenza vaccines. However, there are no licensed vaccines available that contain a standardized amount of NA. FluNhance is designed to fill this void and improve the effectiveness of influenza vaccines in preventing illness.

A Phase II(b) challenge study with FluNhance was conducted by the National Institute of Allergy and Infectious Diseases. Results from the study showed that addition of FluNhance to a licensed seasonal vaccine is safe and does not reduce the effectiveness of the hemagglutinin protein. Subjects treated with FluNhance in combination with a licensed seasonal influenza vaccine experienced milder illness that was of shorter duration compared to subjects treated with a licensed vaccine alone and had a reduced ability to shed the virus, which is key to the prevention of a pandemic.

FluNhance Advantages:

Efficacy-enhancing additive for all influenza vaccines (including pandemic vaccines)

Less severe and shorter duration of illness if infected with influenza

Reduced ability to shed the virus

No antibiotics or preservatives (e.g., thimerosal)

No egg-related byproducts

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SARS (D3252)

Our Severe Acute Respiratory Syndrome (SARS) vaccine candidate (D3252) is comprised of purified recombinant Spike protein from the SARS virus. Preclinical studies have shown that immunization with D3252 can elicit neutralizing antibodies to the virus, similar to the effect seen with our vaccines against influenza.

SARS is a respiratory disease caused by a coronavirus that emerged as an infectious agent from an outbreak in 2003. The main symptoms of SARS include fever, cough, shortness of breath and difficulty breathing. In 2004, the World Health Organization reported that SARS was fatal in approximately 10-15% of cases. There are no preventative or treatment options available for SARS.

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Vaccine Resources

Click on the links below to learn more about influenza and the safety and efficacy of vaccines to prevent infectious diseases.

Centers for Disease Control and Prevention

Families Fighting Flu

National Institute of Allergy and Infectious Diseases

Vaccines

World Health Organization


U.S. Government Reports

President's Council of Advisors on Science and Technology (PCAST)

Influenza Vaccine: Federal Investments in Alternative Technologies and Challenges to Development and Licensure (GAO-11-435)

Influenza Pandemic: Lessons from the H1N1 Pandemic Should be Incorporated in Future Planning (GAO-11-623)

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