GAITHERSBURG, MD, USA I December 16, 2021 I Emergent BioSolutions Inc. (NYSE: EBS) today announced the first participant dosed in its phase 1 study, EBS-UFV-001, evaluating the safety, tolerability, and immunogenicity of the company’s investigational universal influenza vaccine candidate. This current version of Emergent’s universal influenza vaccine candidate contains multiple components intended to induce broad and supra-seasonal immunity against influenza A viruses.
“Emergent remains focused on investing in our diverse portfolio of R&D programs targeting infectious disease and other public health threats,” said Kelly Warfield, Ph.D., senior vice president, research and development at Emergent BioSolutions. “Initiating this phase 1 study demonstrates our commitment to advancing our pipeline and our research and development team’s scientific prowess to adopt an innovative technology and investigate a potential vaccine candidate for a disease that affects millions every year.”
The goal of this single-center, randomized, double blind, placebo-controlled dose-escalation study is to evaluate the safety, tolerability, and immunogenicity of the vaccine candidate at two dose levels and two schedules in 60 healthy adult individuals aged 18 to 45. This phase 1 study, being conducted in Australia, is fully funded by Emergent.
Emergent’s universal influenza vaccine candidate is based on a nanoparticle vaccine that self-assembles during production and that displays a cross-reactive hemagglutinin (HA) antigen for influenza virus A groups 1 and 2. The self-assembling HA stabilized stem nanoparticle technology was developed by and licensed from the National Institute of Allergy and Infectious Diseases Vaccine Research Center. Using this technology, a universal influenza vaccine could be designed to confer protection against divergent, constantly evolving strains and subtypes of influenza virus.i,ii,iii
For more information on the study, visit clinicaltrials.gov.
About Seasonal Influenza
Seasonal influenza is an acute respiratory infection caused by influenza viruses which circulate in all parts of the world. There are four types of seasonal influenza viruses – types A, B, C, and D. Influenza A and B viruses circulate and cause seasonal epidemics of disease.
Seasonal influenza can be characterized by the sudden onset of fever, cough, headache, muscle and joint pain, severe malaise, sore throat and a runny nose. Most people recover from fever and other symptoms within a week without requiring medical attention. However, influenza can cause severe illness or death especially in people at high risk (e.g., pregnant women, children, the elderly, those with multiple medical comorbidities, and those immunocompromised).
According to the WHO, worldwide, these annual epidemics are estimated to result in 3 to 5 million cases of severe illness, and about 290,000 to 650,000 respiratory deaths.iv
About Emergent’s Universal Influenza Vaccine
The goal of the final Emergent universal influenza vaccine candidate is to provide broad protection against multiple, divergent, and constantly evolving influenza virus A and B strains, including both seasonal and pandemic threats. The structure-based design of these vaccine components drives immune responses towards broadly cross-reactive and highly conserved antibody-recognized epitopes on the HA protein. The current EBS-UFV-001 phase 1 study is designed to demonstrate safety, tolerability, and immunogenicity of the influenza virus A components of the vaccine candidate with future studies planned to investigate additional components for full coverage against all influenza virus A and B strains.
About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit our website and follow us on LinkedIn, Twitter, and Instagram.
i Kanekiyo, M. et al. Self-assembling influenza nanoparticle vaccines elicit broadly neutralizing H1N1 antibodies. Nature 499, 102-106 (2013).
ii Yassine, H. M. et al. Hemagglutinin-stem nanoparticles generate heterosubtypic influenza protection. Nat Med 21, 1065-1070 (2015).
iiihttps://pubmed.ncbi.nlm.nih.gov/30808695/
iv https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
SOURCE: Emergent BioSolutions
Post Views: 134
GAITHERSBURG, MD, USA I December 16, 2021 I Emergent BioSolutions Inc. (NYSE: EBS) today announced the first participant dosed in its phase 1 study, EBS-UFV-001, evaluating the safety, tolerability, and immunogenicity of the company’s investigational universal influenza vaccine candidate. This current version of Emergent’s universal influenza vaccine candidate contains multiple components intended to induce broad and supra-seasonal immunity against influenza A viruses.
“Emergent remains focused on investing in our diverse portfolio of R&D programs targeting infectious disease and other public health threats,” said Kelly Warfield, Ph.D., senior vice president, research and development at Emergent BioSolutions. “Initiating this phase 1 study demonstrates our commitment to advancing our pipeline and our research and development team’s scientific prowess to adopt an innovative technology and investigate a potential vaccine candidate for a disease that affects millions every year.”
The goal of this single-center, randomized, double blind, placebo-controlled dose-escalation study is to evaluate the safety, tolerability, and immunogenicity of the vaccine candidate at two dose levels and two schedules in 60 healthy adult individuals aged 18 to 45. This phase 1 study, being conducted in Australia, is fully funded by Emergent.
Emergent’s universal influenza vaccine candidate is based on a nanoparticle vaccine that self-assembles during production and that displays a cross-reactive hemagglutinin (HA) antigen for influenza virus A groups 1 and 2. The self-assembling HA stabilized stem nanoparticle technology was developed by and licensed from the National Institute of Allergy and Infectious Diseases Vaccine Research Center. Using this technology, a universal influenza vaccine could be designed to confer protection against divergent, constantly evolving strains and subtypes of influenza virus.i,ii,iii
For more information on the study, visit clinicaltrials.gov.
About Seasonal Influenza
Seasonal influenza is an acute respiratory infection caused by influenza viruses which circulate in all parts of the world. There are four types of seasonal influenza viruses – types A, B, C, and D. Influenza A and B viruses circulate and cause seasonal epidemics of disease.
Seasonal influenza can be characterized by the sudden onset of fever, cough, headache, muscle and joint pain, severe malaise, sore throat and a runny nose. Most people recover from fever and other symptoms within a week without requiring medical attention. However, influenza can cause severe illness or death especially in people at high risk (e.g., pregnant women, children, the elderly, those with multiple medical comorbidities, and those immunocompromised).
According to the WHO, worldwide, these annual epidemics are estimated to result in 3 to 5 million cases of severe illness, and about 290,000 to 650,000 respiratory deaths.iv
About Emergent’s Universal Influenza Vaccine
The goal of the final Emergent universal influenza vaccine candidate is to provide broad protection against multiple, divergent, and constantly evolving influenza virus A and B strains, including both seasonal and pandemic threats. The structure-based design of these vaccine components drives immune responses towards broadly cross-reactive and highly conserved antibody-recognized epitopes on the HA protein. The current EBS-UFV-001 phase 1 study is designed to demonstrate safety, tolerability, and immunogenicity of the influenza virus A components of the vaccine candidate with future studies planned to investigate additional components for full coverage against all influenza virus A and B strains.
About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit our website and follow us on LinkedIn, Twitter, and Instagram.
i Kanekiyo, M. et al. Self-assembling influenza nanoparticle vaccines elicit broadly neutralizing H1N1 antibodies. Nature 499, 102-106 (2013).
ii Yassine, H. M. et al. Hemagglutinin-stem nanoparticles generate heterosubtypic influenza protection. Nat Med 21, 1065-1070 (2015).
iiihttps://pubmed.ncbi.nlm.nih.gov/30808695/
iv https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
SOURCE: Emergent BioSolutions
Post Views: 134
