Emergent BioSolutions Announces Initiation of Pivotal Phase 3 Study Evaluating the Safety and Immunogenicity of Its Single-Dose Chikungunya Vaccine Candidate, CHIKV VLP
October 15 2021 - 6:30AM
Emergent BioSolutions Inc. (NYSE:EBS) today announced the first
participant dosed in its pivotal phase 3 study evaluating the
safety and immunogenicity of the company’s investigational
chikungunya virus (CHIKV) virus-like particle (VLP) vaccine
candidate, CHIKV VLP, in a single dose. CHIKV VLP is the only
VLP-based vaccine currently in clinical development for active
immunization against chikungunya disease.
“Emergent has achieved a major milestone as we begin our phase 3
study for our single-dose chikungunya vaccine candidate,” said
Karen L. Smith, M.D., Ph.D., executive vice president and chief
medical officer at Emergent BioSolutions. “I am proud of the
Emergent team for bringing us a step closer to potentially having a
critical solution to address this important disease for which no
vaccine or treatment is currently available. A true demonstration
of our commitment to our mission – to protect and enhance
life.”
The goal of this multi-center, randomized, double blind,
placebo-controlled study is to evaluate the safety and
immunogenicity of the CHIKV VLP vaccine candidate in healthy
individuals aged 12 to 64 as well as to demonstrate the consistency
of the chikungunya virus (CHIKV) serum neutralizing antibody (SNA)
response across three manufactured vaccine candidate lots. The
study will observe the CHIKV SNA response at day 22 as measured by
geometric mean titer and seroresponse rate and will enroll at least
3,150 participants in up to 49 U.S. sites.
The structure of the CHIKV VLP is nearly identical to the
wild-type virus but does not pose a risk of replication. Studies
have shown that in general, other VLP vaccines are highly
immunogenic, safe, and typically elicit high titer neutralizing
antibodies, which are needed to protect against chikungunya
virus.i,ii There is currently no licensed vaccine, VLP or
otherwise, to prevent chikungunya virus disease.
Emergent’s CHIKV VLP vaccine candidate 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 designation from the European Medicines Agency in
September 2019. These designations are designed to facilitate the
development or expedite review of medicines that either target an
unmet medical need or may demonstrate substantial improvement over
available therapy.
About the CHIKV VLP vaccine candidateEarly this
year, the company announced two-year persistence data from its
Phase 2 safety and immunogenicity study of CHIKV VLP in 415 healthy
adults. The CHIKV VLP vaccine candidate continued to demonstrate a
favorable safety profile. Two years post-vaccination, SNA responses
were 19 times higher than pre-vaccination titers following a single
adjuvanted 40 µg dose of the CHIKV VLP vaccine candidate,
supporting the persistence of the immune response.iii All subjects
in the single-dose regimen remained seropositive at their one-year
and two-year visits. The vaccine candidate was well-tolerated and
no significant vaccine-related safety concerns were identified. The
majority of solicited adverse events were mild or moderate in
severity and the most frequent was local injection site pain.
About the Chikungunya virusChikungunya virus is
spread to people by infected mosquitoes. Symptoms include fever,
joint pain, headache, muscle pain, joint swelling or rash, with
some symptoms lasting months and years. The geographic distribution
of CHIKV has expanded to more than 100 countries and territories
worldwide.iv,v
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 our ability to fill the need for an approved vaccine to
prevent the chikungunya virus, the safety and immunogenicity of the
product candidate, executing on our development program and the
success of our pivotal trial, 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 RelationsHartwigM@ebsi.com
________________________i Akahata W, Yang ZY, Andersen H, et al.
A virus-like particle vaccine for epidemic chikungunya virus
protects nonhuman primates against infection. Nat Med 2010; 16:
334–38.
ii Qian et al. Recent progress on the versatility of virus-like
particles. Vaccines (Basel). 2020;8(1):139.
iii McCarty J. Long-term Safety and Immunogenicity of an
Adjuvanted Chikungunya Virus-Like Particle (CHIKV VLP)
Vaccine: Results of a Phase 2, Parallel-Group, Randomized,
Double-Blind Trial ISTM 2021
iv Schwartz O, Albert ML. Biology and pathogenesis of
chikungunya virus. Nat Rev Microbiol. 2010;8(7):491–500.
v https://www.cdc.gov/chikungunya/hc/clinicalevaluation.html.
Accessed October 13, 2021.
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