Emergent BioSolutions Receives Department of Defense Award to Evaluate Chikungunya Vaccine Candidate in Post-Approval Field Efficacy Study Using Model-Guided Approach
November 14 2022 - 6:30AM
Emergent BioSolutions Inc. (NYSE:EBS) announced today a research
award by the U.S. Department of Defense (DoD) Congressionally
Directed Medical Research Programs (CDMRP) to evaluate efficacy of
the company’s single-dose chikungunya virus virus-like particle
(CHIKV VLP) vaccine candidate. Emergent will begin the planning
phase, the first of two phases, in collaboration with the Armed
Forces Research Institute of Medical Sciences (AFRIMS) and academic
partners, to enable a post-approval field efficacy study in areas
with active chikungunya virus (CHIKV) transmission.
“Emergent is pleased to gain the support of the CDMRP to verify
the clinical benefit of our CHIKV VLP vaccine candidate for CHIKV
disease through a post-approval field efficacy study,” said Chris
Cabell, M.D., chief medical officer and SVP clinical development at
Emergent BioSolutions. “We look forward to combining our product
development expertise with the capabilities of AFRIMS in
chikungunya epidemiology and field studies, and of our academic
partners in infectious disease modeling and efficacy trial design,
to find ways to address chikungunya disease, a public health threat
for which no vaccine or treatment exists.”
AFRIMS is a research directorate in Thailand and a component of
the Walter Reed Army Institute of Research (WRAIR) in Maryland,
USA. An important element of the AFRIMS mission is to support the
development of vaccines against viruses that are endemic in the
Southeast Asia region.
The planned post-approval study, a multicenter Phase 3b clinical
study, will evaluate the vaccine candidate’s efficacy in preventing
CHIKV disease and assess the utility of a model-guided disease
surveillance framework to optimize execution of a field efficacy
trial using CHIKV as a model emerging pathogen.
This work was supported by the Office of the Assistant Secretary
of Defense for Health Affairs and the Defense Health Agency J9,
Research and Development Directorate, or the U.S. Army Medical
Research Acquisition Activity at the U.S. Army Medical Research and
Development Command through the Peer Reviewed Medical Research
Program (PRMRP) under Award No. W81XWH2210481, with a total program
budget of approximately $10 million for both the planning and
clinical study phases.
The PRMRP supports research across the full range of science and
medicine, with an underlying goal of enhancing the health, care,
and well-being of military service members, veterans, retirees, and
their family members. Opinions, interpretations, conclusions, and
recommendations are those of the author and are not necessarily
endorsed by the Department of Defense.
About the chikungunya virusChikungunya virus is
spread to people by infected mosquitoes. Symptoms include fever,
incapacitating joint pain, headache, muscle pain, joint swelling or
rash. The geographic distribution of CHIKV has expanded to more
than 100 countries and territories worldwide.
About the CHIKV VLP vaccine candidateEmergent
BioSolutions’ CHIKV VLP chikungunya virus vaccine candidate is a
single dose VLP-based vaccine in clinical development for active
immunization against chikungunya disease. It is currently being
investigated in two pivotal phase 3 trials. The CHIKV VLP candidate
is licensed from the National Institute of Allergy and Infectious
Diseases at the National Institutes of Health. It received
Breakthrough Therapy designation and Fast Track designation from
the U.S. Food and Drug Administration in October 2020 and May 2018,
respectively, and PRIME (PRIority MEdicines) designation from the
European Medicines Agency in September 2019.
About Emergent BioSolutionsAt Emergent, our
mission is to protect and enhance life. For over 20 years, we’ve
been at work defending people from things we hope will never
happen—so we are prepared, just in case they ever do. We provide
solutions for complex and urgent public health threats through a
portfolio of vaccines and therapeutics that we develop and
manufacture for governments and consumers. We also offer a range of
integrated contract development and manufacturing services for
pharmaceutical and biotechnology customers. To learn more about how
we plan to protect or enhance 1 billion lives by 2030, 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 our ability to fill the need for an approved vaccine to
prevent chikungunya disease, the effectiveness of the product
candidate, and executing on our development program, 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. Investors should realize that if
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could differ materially
from our expectations. Investors 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 the
planned development program; the timing of and 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. Investors 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.
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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