GAITHERSBURG, MD, USA I March 19, 2019 I Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 3 trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) following a two-dose schedule administered intramuscularly in healthy adults. AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure.
“Emergent is pleased with the advancement of the AV7909 development program,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions. “Dosing the first subject in this large clinical study is a milestone achievement and we look forward to continuing to execute on our development and procurement contract for AV7909.”
AV7909 is designed to elicit a faster immune response than the currently available anthrax vaccine. It is comprised of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant, the immunostimulatory oligodeoxynucleotide compound CPG 7909. The addition of CPG 7909 to AVA has been shown, in previous Phase 1 and Phase 2 studies, to safely accelerate and enhance the immune response.
In evaluating the lot consistency of AV7909, the study will be using three consecutively manufactured lots of the vaccine candidate. This Phase 3 randomized, double-blind, parallel-group study plans to enroll 3,850 adults across 35 sites within the U.S. with an overall study duration of approximately 20 months. More information on the study is available on https://clinicaltrials.gov/ct2/show/NCT03877926.
Contract HHSO100201600030C for the advanced development and delivery of AV7909 is funded by the Biomedical Advanced Research and Development Authority, a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
About Emergent BioSolutions
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats. We aspire to be a Fortune 500 company recognized for protecting and enhancing life, driving innovation, and living our values. Additional information about the company may be found at www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.
SOURCE: Emergent BioSolutions
Post Views: 741
GAITHERSBURG, MD, USA I March 19, 2019 I Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 3 trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) following a two-dose schedule administered intramuscularly in healthy adults. AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure.
“Emergent is pleased with the advancement of the AV7909 development program,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions. “Dosing the first subject in this large clinical study is a milestone achievement and we look forward to continuing to execute on our development and procurement contract for AV7909.”
AV7909 is designed to elicit a faster immune response than the currently available anthrax vaccine. It is comprised of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant, the immunostimulatory oligodeoxynucleotide compound CPG 7909. The addition of CPG 7909 to AVA has been shown, in previous Phase 1 and Phase 2 studies, to safely accelerate and enhance the immune response.
In evaluating the lot consistency of AV7909, the study will be using three consecutively manufactured lots of the vaccine candidate. This Phase 3 randomized, double-blind, parallel-group study plans to enroll 3,850 adults across 35 sites within the U.S. with an overall study duration of approximately 20 months. More information on the study is available on https://clinicaltrials.gov/ct2/show/NCT03877926.
Contract HHSO100201600030C for the advanced development and delivery of AV7909 is funded by the Biomedical Advanced Research and Development Authority, a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
About Emergent BioSolutions
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats. We aspire to be a Fortune 500 company recognized for protecting and enhancing life, driving innovation, and living our values. Additional information about the company may be found at www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.
SOURCE: Emergent BioSolutions
Post Views: 741
