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Inovio Zika Phase 1 Clinical Trial Design Superior To NIH Zika Phase 1 Clinical Trial Design 10 comments

Summary

Inovio Zika phase 1 clinical trial is superior to NIH Zika phase 1 clinical trial.

Taxpayers will waste $2 billion or more on the NIH solution which is not effective.

Inovio has a chance at addressing the Zika problem (protecting pregnant mothers) whereas NIH does not.

Need For Effective Vaccination of Pregnant Mothers Against Zika Virus

As of August 13th, 2016 there have been 1872 confirmed cases of congenital syndrome associated with the Zika virus ( table 1), many of which have been of the form of microcephaly (babies born with unusually small head circumference). The numbers of Zika cases are growing rapidly worldwide during the summer seasons of peak activity of the Aedes aegypti mosquito. For pregnant mothers in affected countries there is concern for the new born babies and people demand action.

Early Vaccine Trials for Zika - Inovio (NASDAQ:INO) Solution Superior to NIH Solution

There are two early Zika vaccine candidates in phase 1 clinical trials. And while both candidates look similar on the surface (both use plasmid DNA to target the premembrane and envelope regions of Zika) the solutions are vastly different upon a more detailed look.

Highlights on the difference between the two early Zika vaccine approaches follow which clearly show that the Inovio solution is superior:

Inovio Pharmaceuticals solution to Zika vaccine:

  • From clinic to phase 1 safety data in 12 months [
    ]
  • Cost of clinic to phase 1 safety data per one estimate:$300,000[
    ]
  • Peak immune response and days to peak: 40,000 end point titers at day 30 [ slide 9, bottom right]
  • A "very good" immune response (15,000 end point titers) at day 20 [ slide 9, bottom right]
  • Possible (?) ability to protect mothers in pregnancy - needs to be proven
  • If proven to protect mothers in pregnancy the amount of vaccine needed to be produced to protect those mothers would be low in comparison to the NIH approach
  • Uses
    for faster uptake of vaccine and therefore faster immunogenicity (able to protect pregnant mothers faster)
  • Uses intradermal delivery to the surface of the skin without puncturing the skin itself
  • Requires only 1 dose for protection
  • Requires only 1 or 2 milligrams ( about the size of a grain of sand) for dose size - small amount of vaccine to produce
  • Leverages technology from the father of DNA vaccines Dr. David B. Weiner from the Wistar Institute. The platform and technology is an evolution and optimization of research from Dr. Weiner over a span of 30 years.
  • Leverages infectious disease expert and scientist of the year Dr. Gary Kobinger from Laval University

Clearly the Inovio approach is superior to the NIH approach but what is congress led ("led" being the key word) to believe?

When the Zika epidemic had a recognized impact by the CDC in early 2016 congress asked that the director of NIAID/NIH, Dr. Anthony Fauci, provide testimony regarding the Zika outbreak. Dr. Anthony Fauci testified a total of 7 times with congress and during those 7 speeches Dr. Anthony Fauci presented the NIH solution for Zika to congress but never once mentioned what other companies or organizations were doing to fight the Zika virus. During the same period of time congress would not listen to testimony regarding Zika from any other source than Dr. Anthony Fauci. This was the first warning sign that something was wrong. How could we permit the NIH which is a national health entity to be biased towards its own solutions to Zika when not allowing for an unbiased representation of other solutions to Zika such as Inovio's? And how could...


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