Top-Line Seroprotection Rates Exceed 90% in each of Four Vaccine Components; VAX2012Q to Proceed into Phase 2 Evaluation in 2015
Cranbury, NJ, USA I November 11, 2014 I VaxInnate Corporation, a biotechnology firm pioneering next-generation vaccine technology, announced today that enrollment has concluded in the Phase 1 study of the Company’s experimental recombinant quadrivalent seasonal influenza vaccine, VAX2012Q. Top-line results showed 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. VAX2012Q was generally well tolerated, with mild to moderate arm pain the most commonly reported adverse event. Complete study results will be submitted for future publication.
“VAX2012Q continues to show great promise as a seasonal influenza vaccine in adults,” commented Dr. Lynda Tussey, vice president of research and development at VaxInnate. “Based on these top-line results, and pending the completion of our planned Phase 1b/2 study in elderly individuals that will begin later this month, we expect to advance VAX2012Q into a Phase 2 study in healthy adults 18 years of age and older in 2015. This next stage of clinical development will confirm the VAX2012Q dose in adult and elderly individuals, and will support further development and pursuit of licensure.”
This Phase 1 trial enrolled 316 healthy adults aged 18-40 who were each evaluated for vaccine tolerability and immune response at 21 days post-vaccination. Study participants will be monitored for one year following their vaccination to assess long-term safety. The trial was funded under Contract No. HHSO100201100011C from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.
Wayne Pisano, VaxInnate’s president and chief executive officer, commented, “These immunogenicity results, combined with our advanced recombinant technology, will ensure reliability of supply and the ability to manufacture vaccine rapidly – potentially reducing total production times from the typical six-to-nine month turnaround to just three months.”
“We believe this represents a significant value considering that the demand in the U.S. alone has increased to nearly 150 million doses annually. With this growing demand and given that most influenza immunizations occur in an 8-week period, current manufacturing technologies and capacities have historically struggled to keep up,” Pisano continued. “And with the recent recommendation to add a 4th influenza strain to the seasonal vaccine, there is even greater pressure on the current technologies and manufacturing capacities. We believe that VAX2012Q and our recombinant manufacturing technology have strong commercial potential in this market, and look forward to reporting additional data from our upcoming studies in 2015.”
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.
About VaxInnate
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).
SOURCE: VaxInnate
Post Views: 199
Top-Line Seroprotection Rates Exceed 90% in each of Four Vaccine Components; VAX2012Q to Proceed into Phase 2 Evaluation in 2015
Cranbury, NJ, USA I November 11, 2014 I VaxInnate Corporation, a biotechnology firm pioneering next-generation vaccine technology, announced today that enrollment has concluded in the Phase 1 study of the Company’s experimental recombinant quadrivalent seasonal influenza vaccine, VAX2012Q. Top-line results showed 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. VAX2012Q was generally well tolerated, with mild to moderate arm pain the most commonly reported adverse event. Complete study results will be submitted for future publication.
“VAX2012Q continues to show great promise as a seasonal influenza vaccine in adults,” commented Dr. Lynda Tussey, vice president of research and development at VaxInnate. “Based on these top-line results, and pending the completion of our planned Phase 1b/2 study in elderly individuals that will begin later this month, we expect to advance VAX2012Q into a Phase 2 study in healthy adults 18 years of age and older in 2015. This next stage of clinical development will confirm the VAX2012Q dose in adult and elderly individuals, and will support further development and pursuit of licensure.”
This Phase 1 trial enrolled 316 healthy adults aged 18-40 who were each evaluated for vaccine tolerability and immune response at 21 days post-vaccination. Study participants will be monitored for one year following their vaccination to assess long-term safety. The trial was funded under Contract No. HHSO100201100011C from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.
Wayne Pisano, VaxInnate’s president and chief executive officer, commented, “These immunogenicity results, combined with our advanced recombinant technology, will ensure reliability of supply and the ability to manufacture vaccine rapidly – potentially reducing total production times from the typical six-to-nine month turnaround to just three months.”
“We believe this represents a significant value considering that the demand in the U.S. alone has increased to nearly 150 million doses annually. With this growing demand and given that most influenza immunizations occur in an 8-week period, current manufacturing technologies and capacities have historically struggled to keep up,” Pisano continued. “And with the recent recommendation to add a 4th influenza strain to the seasonal vaccine, there is even greater pressure on the current technologies and manufacturing capacities. We believe that VAX2012Q and our recombinant manufacturing technology have strong commercial potential in this market, and look forward to reporting additional data from our upcoming studies in 2015.”
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.
About VaxInnate
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).
SOURCE: VaxInnate
Post Views: 199
