Top-line results expected in second half of 2015
Cranbury, NJ, June 3, 2015 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology platform, today announced the initiation of a double-blind, randomized, active comparator controlled Phase 2 study to evaluate the safety and immunogenicity of its VAX2012Q quadrivalent seasonal influenza vaccine candidate.
The active comparator in the study is Fluzone® Quadrivalent, a commercially available vaccine. The VAX2012Q clinical trial is being fully funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS), under Contract No. HHSO100201100011C.
“We believe our proprietary recombinant vaccine production technology offers significant benefits over traditional manufacturing methods, including reliability and cost effectiveness,” commented Wayne Pisano, VaxInnate’s president and chief executive officer. “In addition, our technology also has the important benefit of speed, which can be essential when reacting to unexpected strain drifts, as we witnessed earlier in 2015. The initiation of this Phase 2 study represents another important milestone on our path to commercialization, and we look forward to seeing top-line results later this year.”
VaxInnate plans to enroll up to 450 healthy adults 18-64 years of age at six sites in the United States. Study participants will receive, in a blinded fashion, a single dose of vaccine, either VAX2012Q at 2 mcg or 3 mcg per component or the standard 15 mcg per component dose of Fluzone® Quadrivalent. The study will measure immune response to each of the four components of VAX2012Q. Additionally, VaxInnate will monitor immunogenicity and safety after 21 and 90 days, and participants will be followed for one year following their vaccination to assess long-term safety. The Company expects to complete patient enrollment by mid-2015 and report preliminary results in the second half of the year.
This Phase 2 study follows the successful conclusion of a Phase 1 trial of VAX2012Q in healthy adults 18-40 years of age in which doses as low as 2 mcg per component elicited robust immune responses to each of the four vaccine components. The vaccine was generally well-tolerated, with mild to moderate arm pain the most commonly reported adverse event.
Powerful Vaccine Technology Platform
VaxInnate’s technology platform is based on proprietary toll-like receptor (TLR) technology, which genetically fuses vaccine antigens to the bacterial protein flagellin, a TLR5 agonist. These fusion proteins potentiate the immune response through sequential triggering of the innate and adaptive immune systems. Using this technology, vaccines can be produced using low-cost, highly scalable recombinant DNA techniques, thus avoiding many of the challenges of conventional vaccine production. This technology has the potential for production of significantly greater quantities of vaccine in extremely rapid timeframes, with very low infrastructure costs.
VaxInnate is a privately held biotechnology company in Cranbury, NJ that is pioneering a breakthrough technology platform for use in developing novel and proprietary vaccines. Influenza vaccines manufactured using this technology have been shown to be safe and immunogenic in clinical studies. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic influenza, Clostridium difficile and dengue. VaxInnate’s ongoing studies of seasonal and pandemic flu vaccines are largely supported under Contract No. HHSO100201100011C with the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS).
To learn more about VaxInnate and to explore the company’s technology platform, please visit the website at www.vaxinnate.com.
Aline B. Schimmel
Christine C. Mayer