InDevR gets NIAID support for verification, validation studies on new potency test for influenza viruses

InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for verification and validation studies on a new potency test for influenza viruses with pandemic potential. The resulting VaxArray® Pandemic Hemagglutinin Potency test will complement InDevR's VaxArray® Seasonal Hemagglutinin Potency test kit, which is commercially available. This project was supported as part of the inter-agency Influenza Vaccine Improvement Initiative through the Department of Health and Human Services.

The so-called 5^th wave of avian influenza A/H7N9 viruses represents the latest threat of a lethal influenza pandemic. According to the World Health Organization, "As of 16 May 2017, a total of 1486 laboratory-confirmed cases of human infection with avian influenza A(H7N9) viruses, including at least 571 deaths, have been reported to WHO... The number of human infections with avian influenza A(H7N9) viruses and the geographical distribution of human cases in the fifth epidemic wave (i.e. onset since 1 October 2016) is greater than any earlier wave."

There is an urgent unmet need for a potency test that is rapid, has sufficient sensitivity to track potency in dose-sparing vaccines, and is capable of working in the presence of adjuvants. The current gold standard method for flu vaccine potency determination, single radial immunodiffusion (SRID), is not sufficiently sensitive and not compatible with common adjuvants that are known to enhance vaccine performance. Most importantly, it can take months to develop the reference reagents needed to perform the test, which, as demonstrated in the 2009 H1N1 pandemic can delay the delivery of flu vaccine. In contrast, the VaxArray vaccine potency testing platform developed under NIH Small Business Innovation Research (SBIR) grant R44AI102318 meets all of these requirements and does not rely exclusively on traditional reference reagents.

"These supplemental funds from NIAID will enable InDevR to complete all verification and validation activities for our VaxArray pandemic influenza potency test, which has been demonstrated to work with recent H7 and H5 influenza viruses. We anticipate the new reagent kit being available to vaccine producers before the Northern Hemisphere flu season is in full swing this year and we encourage interested parties to contact us for early access," said Kathy Rowlen, Chief Executive Officer of InDevR.