Emergent BioSolutions Presents Data from Phase 2 Study Evaluating Safety and Immunogenicity of Chikungunya Vaccine Candidate in Prior Recipients of Other Alphavirus Vaccines
November 01 2022 - 3:05PM
Emergent BioSolutions Inc. (NYSE:EBS) announced results from a
Phase 2 study evaluating the safety and immunogenicity of the
company’s adjuvanted single dose chikungunya virus virus-like
particle (CHIKV VLP) vaccine candidate in prior recipients of other
investigational alphavirus vaccines. The study demonstrated that
the CHIKV VLP vaccine candidate was well-tolerated and immunogenic
in both alphavirus vaccine-naïve participants and participants
previously vaccinated against the Venezuelan equine encephalitis
virus. The findings were presented at the American Society of
Tropical Medicine and Hygiene (ASTMH) annual meeting.
“We are pleased with these positive Phase 2 study results that
support the potential utility and continued development of a
chikungunya vaccine candidate to help prevent chikungunya disease,
including in those who have previously received another alphavirus
vaccine,” said Chris Cabell, M.D., chief medical officer and SVP
clinical development at Emergent BioSolutions. “There are currently
no approved vaccines or treatments for chikungunya disease, and we
are committed to advancing our program to help address this unmet
medical need.”
“The data from this trial are supportive of continued evaluation
of this novel CHIKV VLP vaccine candidate for use in U.S. military
personnel, including in those previously receiving other alphavirus
vaccines, given their heightened exposure risk during worldwide,
short-notice deployments,” said study principal investigator U.S.
Army Lt. Col. Melinda J. Hamer, from the Walter Reed Army Institute
of Research. This Phase 2 parallel group, age- and
gender-matched, open-label study evaluating the safety and
immunogenicity of an adjuvanted CHIKV VLP vaccine candidate in
prior recipients of experimental alphavirus vaccines, in comparison
to a cohort of alphavirus vaccine-naïve individuals, enrolled 60
healthy adults at two U.S. sites.
The vaccine candidate was well-tolerated with no notable
difference in the incidence of adverse events between the groups.
The majority of solicited adverse events were mild or moderate. The
most common adverse event was local injection site pain. The
seroconversion rate 21 days post-vaccination was 100% in both
groups. A higher percentage of prior alphavirus vaccine candidate
recipients had a four-fold rise on study day 8 than the alphavirus
vaccine-naïve group.
The ASTMH annual meeting is being held in Seattle from October
30 to November 3, 2022. In addition to the oral presentation on the
chikungunya vaccine candidate, Emergent has poster presentations on
its smallpox vaccine, cholera vaccine, and Lassa fever vaccine
candidate.
About the chikungunya virus Chikungunya
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 BioSolutions At 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 Statement This 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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