Top-line results expected in second half of 2015
Cranbury, NJ, USA I June 3, 2015 I VaxInnate Corporation, a biotechnology firm pioneering abreakthrough vaccine technology platform, today announced theinitiation of a double-blind, randomized, active comparatorcontrolled Phase 2 study to evaluate the safety and immunogenicityof its VAX2012Q quadrivalent seasonal influenza vaccinecandidate.
The active comparator in the study is Fluzone(R)Quadrivalent, a commercially available vaccine. The VAX2012Qclinical trial is being fully funded by the Office of the AssistantSecretary for Preparedness and Response, Biomedical AdvancedResearch and Development Authority (BARDA),Department of Health and Human Services (HHS), under Contract No.HHSO100201100011C.
“We believe our proprietary recombinant vaccine productiontechnology offers significant benefits over traditionalmanufacturing methods, including reliability and costeffectiveness,” commented Wayne Pisano,VaxInnate’s president and chief executive officer. “In addition,our technology also has the important benefit of speed, which canbe essential when reacting to unexpected strain drifts, as wewitnessed earlier in 2015. The initiation of this Phase 2 studyrepresents another important milestone on our path tocommercialization, and we look forward to seeing top-line resultslater this year.”
VaxInnate plans to enroll up to 450 healthy adults 18-64 yearsof age at six sites in the United States. Study participants willreceive, in a blinded fashion, a single dose of vaccine, eitherVAX2012Q at 2 mcg or 3 mcg per component or the standard 15 mcg percomponent dose of Fluzone(R) Quadrivalent. The study willmeasure immune response to each of the four components of VAX2012Q.Additionally, VaxInnate will monitor immunogenicity and safetyafter 21 and 90 days, and participants will be followed for oneyear following their vaccination to assess long-term safety. TheCompany expects to complete patient enrollment by mid-2015 andreport preliminary results in the second half of the year.
This Phase 2 study follows the successful conclusion of a Phase1 trial of VAX2012Q in healthy adults 18-40 years of age in whichdoses as low as 2 mcg per component elicited robust immuneresponses to each of the four vaccine components. The vaccine wasgenerally well-tolerated, with mild to moderate arm pain the mostcommonly reported adverse event.
Powerful Vaccine Technology Platform
VaxInnate’s technology platform is based on proprietary toll-likereceptor (TLR) technology, which genetically fuses vaccineantigens to the bacterial protein flagellin, a TLR5 agonist. Thesefusion proteins potentiate the immune response through sequentialtriggering of the innate and adaptive immune systems. Using thistechnology, vaccines can be produced using low-cost, highlyscalable recombinant DNA techniques, thus avoiding many of thechallenges of conventional vaccine production. This technology hasthe potential for production of significantly greater quantities ofvaccine in extremely rapid timeframes, with very low infrastructurecosts.
About VaxInnate
VaxInnate is a privately held biotechnology company in Cranbury,NJ that is pioneering a breakthrough technology platform for use indeveloping novel and proprietary vaccines. Influenza vaccinesmanufactured using this technology have been shown to be safe andimmunogenic in clinical studies. VaxInnate’s vaccines focus oninfectious diseases, including seasonal and pandemic influenza,Clostridium difficile and dengue. VaxInnate’s ongoingstudies of seasonal and pandemic flu vaccines are largely supportedunder Contract No. HHSO100201100011C with the Office of theAssistant Secretary for Preparedness and Response, BiomedicalAdvanced Research and Development Authority (BARDA), Department ofHealth and Human Services (HHS).
SOURCE: VaxInnate
Post Views: 243
Top-line results expected in second half of 2015
Cranbury, NJ, USA I June 3, 2015 I VaxInnate Corporation, a biotechnology firm pioneering abreakthrough vaccine technology platform, today announced theinitiation of a double-blind, randomized, active comparatorcontrolled Phase 2 study to evaluate the safety and immunogenicityof its VAX2012Q quadrivalent seasonal influenza vaccinecandidate.
The active comparator in the study is Fluzone(R)Quadrivalent, a commercially available vaccine. The VAX2012Qclinical trial is being fully funded by the Office of the AssistantSecretary for Preparedness and Response, Biomedical AdvancedResearch and Development Authority (BARDA),Department of Health and Human Services (HHS), under Contract No.HHSO100201100011C.
“We believe our proprietary recombinant vaccine productiontechnology offers significant benefits over traditionalmanufacturing methods, including reliability and costeffectiveness,” commented Wayne Pisano,VaxInnate’s president and chief executive officer. “In addition,our technology also has the important benefit of speed, which canbe essential when reacting to unexpected strain drifts, as wewitnessed earlier in 2015. The initiation of this Phase 2 studyrepresents another important milestone on our path tocommercialization, and we look forward to seeing top-line resultslater this year.”
VaxInnate plans to enroll up to 450 healthy adults 18-64 yearsof age at six sites in the United States. Study participants willreceive, in a blinded fashion, a single dose of vaccine, eitherVAX2012Q at 2 mcg or 3 mcg per component or the standard 15 mcg percomponent dose of Fluzone(R) Quadrivalent. The study willmeasure immune response to each of the four components of VAX2012Q.Additionally, VaxInnate will monitor immunogenicity and safetyafter 21 and 90 days, and participants will be followed for oneyear following their vaccination to assess long-term safety. TheCompany expects to complete patient enrollment by mid-2015 andreport preliminary results in the second half of the year.
This Phase 2 study follows the successful conclusion of a Phase1 trial of VAX2012Q in healthy adults 18-40 years of age in whichdoses as low as 2 mcg per component elicited robust immuneresponses to each of the four vaccine components. The vaccine wasgenerally well-tolerated, with mild to moderate arm pain the mostcommonly reported adverse event.
Powerful Vaccine Technology Platform
VaxInnate’s technology platform is based on proprietary toll-likereceptor (TLR) technology, which genetically fuses vaccineantigens to the bacterial protein flagellin, a TLR5 agonist. Thesefusion proteins potentiate the immune response through sequentialtriggering of the innate and adaptive immune systems. Using thistechnology, vaccines can be produced using low-cost, highlyscalable recombinant DNA techniques, thus avoiding many of thechallenges of conventional vaccine production. This technology hasthe potential for production of significantly greater quantities ofvaccine in extremely rapid timeframes, with very low infrastructurecosts.
About VaxInnate
VaxInnate is a privately held biotechnology company in Cranbury,NJ that is pioneering a breakthrough technology platform for use indeveloping novel and proprietary vaccines. Influenza vaccinesmanufactured using this technology have been shown to be safe andimmunogenic in clinical studies. VaxInnate’s vaccines focus oninfectious diseases, including seasonal and pandemic influenza,Clostridium difficile and dengue. VaxInnate’s ongoingstudies of seasonal and pandemic flu vaccines are largely supportedunder Contract No. HHSO100201100011C with the Office of theAssistant Secretary for Preparedness and Response, BiomedicalAdvanced Research and Development Authority (BARDA), Department ofHealth and Human Services (HHS).
SOURCE: VaxInnate
Post Views: 243
