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FluBlok
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FluBlok Potential Benefits(contains 3x45µg
recombinant hemagglutinin)

• Influenza rHA antigens are produced in insect
  cells protein based vaccine with low endotoxin
  content
• Manufacture of rHA does not include formalin
  inactivation or organic extraction procedures,
  thus avoiding possible denaturing effects and
  additional safety concerns due to residual toxic
  chemicals in the vaccine.
• rHA protein is highly purified and does not
  contain egg protein or other contaminants from
  eggs, eliminating possible adverse reactions in
  individuals with severe egg allergies.
• Selection or adaptation of influenza virus
  strains that produce at high levels in eggs is
  not required, making it possible to choose the
  best genetic match between the vaccine strains
  and the influenza virus strains that are causing
  disease.
• The cloning, expression and manufacture of
  FluBlok can be accomplished in a short period of
  time (less than 2 months).
• FluBlok provides an alternative to the currently
  licensed influenza vaccines in the U.S., all of
  which require access to significant quantities of
  embryonated chicken eggs.
• Manufacturing of FluBlok does not require
  biocontainment manufacturing facilities, which
  may result in the more rapid manufacturing of
  vaccine in the event of the emergence of a new
  epidemic or pandemic strain of influenza virus.

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Clinical Studies to Support BLA under accelerated
approval mechanism

• BLA filing to support licensure expected within
  the next few months
• PSC01 Efficacy Study in Healthy Adults (451
  subjects 111)
• Placebo controlled and two doses of FluBlok
• PSC03 Efficacy Study in Adults older than 65y
  (869 subjects 11)
• Active controlled study (FluZone)
• PSC04 Field Efficacy Study in Healthy Adults
  (4650 subjects 11)
• (Interim Day 28 Safety and Immunogenicity
  available)
• Placebo controlled
• PSC06 Non-inferiority Immunogenicity/Efficacy
  Study in 600 Healthy Adults (50-64y)
• (Interim Day 28 Safety and Immunogenicity
  available)
• Active controlled study (FluZone)

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PSC01 - FluBlok Phase II/III Field Study Summary
of Results
Efficacy Commercial dose (135µg total rHA) provided 100 protection 54 reduction (p 0.05) in CDC-ILI vs. placebo Lower dose (75µg total rHA 15µg H1 15µg B, 45µg H3 ) also demonstrated 71 protective efficacy and 30 reduction in CDC-ILI vs. placebo Significant dose response effect confirmed for H1 and B
Highly Immunogenic Protective levels for all antigens for at least 6 months H3 component high and sustained immunogenicity and long lasting titers
Protection Against Drifted Strains Protected 100 of vaccinated people against viruses that had changed (drifted)
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PSC01 - Results Published In JAMA
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PSC03 Difference in Proportions of Subjects with
Seroconversion or Significant Increase in HAI
Titers at Day 28
CBER Criterion for non-inferiority lower bound
of the two-sided 95 CI for the of subjects
achieving seroconversion should meet or exceed
30.
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PSC03 -continued
CBER Criterion for a non-inferiority the upper
bound of the two-sided 95 CI on the ratio of the
GMTs does not exceed 1.5. This criterion is met
for FluBlok for all antigens