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 InfluenzaSeasonal 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 VaccineThe
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 BioSolutionsEmergent
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.
Safe Harbor StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements,
other than statements of historical fact, including statements
regarding the safety, tolerability and immunogenicity of the
product candidate, executing on our development program, the
success of our clinical trial, the inducement of broad and
supra-seasonal immunity against influenza A, advancing our pipeline
and potential solutions to combat influenza A and B, are
forward-looking statements. These forward-looking statements are
based on our current intentions, beliefs and expectations regarding
future events. We cannot guarantee that any forward-looking
statement will be accurate. The reader should realize that if
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could differ materially
from our expectations. Readers are, therefore, cautioned not to
place undue reliance on any forward-looking statement. Any
forward-looking statement speaks only as of the date of this press
release, and, except as required by law, we do not undertake to
update any forward-looking statement to reflect new information,
events or circumstances.
There are a number of important factors that could cause the
company's actual results to differ materially from those indicated
by such forward-looking statements, including the success of this
and other related clinical trials and the overall development
program; the timing of and our ability to obtain and maintain
regulatory approvals for the product candidate; and our
commercialization, marketing and manufacturing capabilities. The
foregoing sets forth many, but not all, of the factors that could
cause actual results to differ from our expectations in any
forward-looking statement. Readers should consider this cautionary
statement, as well as the risk factors identified in our periodic
reports filed with the SEC, when evaluating our forward-looking
statements.
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).
iii https://pubmed.ncbi.nlm.nih.gov/30808695/
iv
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280BurrowsR@ebsi.com
Media Contact:Matt HartwigSenior
Director, Media Relationsmediarelations@ebsi.com
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