Study to assess safety and immunogenicity in high-priority, at-risk population; top-line results expected in second quarter of 2015
VaxInnate Initiates Phase 1b/2 Clinical Trial of Quadrivalent Seasonal Influenza Vaccine Candidate, VAX2012Q, in Elderly
Cranbury, NJ, Dec. 8, 2014 (GLOBE NEWSWIRE) -- VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology platform, today announced the initiation of a double-blind, randomized, placebo-controlled Phase 1b/2 study of VAX2012Q in healthy adults 65-75 years of age.
VAX2012Q is the Company's seasonal quadrivalent influenza vaccine candidate, which incorporates a bacterial flagellin protein designed to enhance the adaptive immune response to the vaccine. This Phase 1b/2 study will evaluate the vaccine's safety and immunogenicity in this elderly population. The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, has funded the production of VAX2012Q for use in this clinical study under contract No. HHSO100201100011C.
"We believe our novel, differentiated vaccine platform and production scalability is particularly well-suited to develop vaccines for the elderly, whose immune systems typically require greater stimulation, often in the form of increased antigen, to generate a protective response. In this seasonal influenza trial, we will evaluate several doses of VAX2012Q to determine the dose of antigen for future development, and expect top-line data in the second quarter of 2015," commented Wayne Pisano, VaxInnate's president and chief executive officer.
"Traditional egg-based vaccine manufacturers have been historically challenged to produce adequate supply as influenza vaccine demand grows globally, and the added increase in antigen needed for a high-dose elderly product further taxes production," Pisano continued. "We believe our recombinant manufacturing technology and the dose-sparing attributes of our vaccine will allow us to produce VAX2012Q in significantly greater quantities and in less time than is possible with current vaccine production methods, which will give us a strong advantage in this segment of the market."
VAX2012Q is comprised of four seasonal influenza strains, each fused to a flagellin protein, which acts as a toll-like receptor (TLR) ligand. The TLR class of proteins is known to activate the innate immune system, which in turn enhances the adaptive immune response to vaccines. In a previous clinical study, VAX125, a vaccine comprised of one seasonal influenza H1N1 strain, was shown to elicit a robust immune response in the elderly.1
This Phase 1b/2 study will enroll up to 200 healthy adults 65-75 years of age, who will be administered either VAX2012Q or placebo. In addition to safety, which is the trial's primary objective, the study will also assess the dose levels necessary to produce a robust immune response in the majority of study participants. Individuals will be monitored for one year following their vaccination to assess long-term safety.
VAX2012Q recently reported positive top-line results from a Phase 1 study of 316 healthy adults 18-40 years of age, showing that doses as low as 2 mcg per component were immunogenic, with mean seroprotection rates exceeding 90% for each of the four vaccine components at the day 21 clinic visit. 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 potentiates the immune response. The TLR technology genetically fuses vaccine antigens to the bacterial protein flagellin, and this sequentially triggers 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 demonstrated excellent immunogenicity in the elderly population, a group that is typically less responsive to influenza vaccines. 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 significantly funded 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.
1) Taylor, DN et al. Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125, STF2.HA1 SI). J.Vaccine; 29 (2011) 4897-4902.
Christine C. Mayer
Aline B. Schimmel