Emergent BioSolutions Initiates Phase 1 Study Evaluating Lassa Virus Vaccine Candidate
September 06 2022 - 6:30AM
Emergent BioSolutions Inc. (NYSE: EBS) today announced that it has
dosed the first participant in its Phase 1 study evaluating the
safety and immunogenicity of EBS-LASV, a recombinant VSV-vectored
Lassa virus vaccine candidate being developed for prevention of
disease caused by Lassa virus infection. Emergent and CEPI (the
Coalition for Epidemic Preparedness Innovations) are co-funding
this program.
“Over the last 24 years, Emergent’s mission to
protect and enhance life and commitment to help mitigate public
health threats have remained unchanged,” said Kelly Warfield,
Ph.D., SVP for research and development at Emergent BioSolutions.
“We are proud to deploy our product development and partnering
capabilities to address emerging infectious diseases like Lassa
fever, for which there is currently no approved vaccine or
therapeutic, and to advance our pipeline for patients.”
This Phase 1 study, a randomized,
placebo-controlled, dose-escalation study, will evaluate the safety
and immunogenicity of Emergent’s rVSV-vectored Lassa virus vaccine
in approximately 36 healthy adults at the Navrongo Health Research
Centre and Kintampo Health Research Centre in Ghana. View the
clinical trial registry.
“There have been a series of exciting developments
within the Lassa R&D field in recent years and today’s
announcement from Emergent is another key milestone moment as we
progress towards developing and deploying tools that can help
protect vulnerable populations across West Africa—and possible
wider areas —against this potentially fatal threat,” explained
CEPI’s Executive Director of Vaccine R&D, Dr. Melanie Saville.
“This is particularly important as Lassa cases continue to be
reported across the region, while health systems also battle other
worrisome infectious disease outbreaks.”
About Lassa VirusAn estimated
100,000 to 300,000 cases of Lassa virus infection occur each year,1
although the true disease burden is unknown. Lassa virus—a
single-stranded RNA virus belonging to the family Arenaviridae—can
cause the acute viral hemorrhagic illness known as Lassa fever.
First described in the 1950s, the virus was identified in 1969
after two missionary nurses died from the disease in the Nigerian
town of Lassa.2 The virus is spread to humans via contact with food
or household items that have been contaminated with urine or feces
from infected Mastomys rats. Person-to-person transmission
occurs in both community and healthcare settings, where the virus
can spread via contaminated medical equipment.3 Sexual transmission
of Lassa virus has also been reported.4
About 80% of people who become infected have no
symptoms. One in five infections results in severe disease, where
the virus affects several organs such as the liver, spleen and
kidneys.5 The virus is endemic in Benin, Ghana, Guinea, Liberia,
Mali, Sierra Leone, and Nigeria, but probably exists in other West
African countries as well. There is currently no approved vaccine
or therapeutic that protects against or treats Lassa fever.6 There
have been outbreaks of Lassa fever in Liberia, Nigeria, and Sierra
Leone.7
About EBS-LASV vaccine development
The VesiculoVax™ vaccine delivery platform is the result of basic
research funding provided by the U.S. Department of Health and
Human Services, National Institutes of Health (NIH), and National
Institute of Allergy and Infectious Diseases (NIAID) initially to
Yale University and subsequently to Profectus (Auro Vaccines). In
2018, Emergent acquired development rights to the Profectus Lassa
vaccine candidate now named EBS-LASV. CEPI is co-funding
development of EBS-LASV as a monovalent vaccine to protect against
Lassa fever, as part of its plan to reduce the threat of future
known and novel epidemic and pandemic threats. Its goal, as part of
the plan, is to support the development of a Lassa vaccine towards
licensure. To push forward this aim, CEPI has also initiated
Enable, the largest-ever Lassa fever epidemiological study to
increase knowledge of the true Lassa disease burden across West
Africa and better inform the design of future late-stage Lassa
vaccine trials.
Emergent supports CEPI’s commitment to global
equitable access for delivering a safe and effective LASV vaccine
candidate to populations that need it at a price that public
service agencies find affordable. Emergent has also agreed to
rapidly share all data and results arising from its CEPI-supported
project in Open Access journals/website where possible.
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 a Lassa virus
vaccine and the safety and immunogenicity of the product candidate
are forward-looking statements. 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 statements, which speak
only as of the date of this press release.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 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.
1 US CDC. Lassa fever: fact sheet.
https://www.cdc.gov/vhf/lassa/pdf/factsheet.pdf (accessed August 4,
2022)2 Gov.UK. Lassa fever: origins, reservoirs, transmission and
guidelines
https://www.gov.uk/guidance/lassa-fever-origins-reservoirs-transmission-and-guidelines
(accessed August 4, 2022)3 WHO. Lassa fever: fact sheet.
http://www.who.int/en/news-room/fact-sheets/detail/lassa-fever
(accessed August 4, 2022)4 Gov.UK. Lassa fever: origins,
reservoirs, transmission and guidelines
https://www.gov.uk/guidance/lassa-fever-origins-reservoirs-transmission-and-guidelines
(accessed August 4, 2022)5 WHO. Lassa fever: fact sheet.
http://www.who.int/en/news-room/fact-sheets/detail/lassa-fever
(accessed August 4, 2022)6 WHO. Lassa fever: fact sheet.
http://www.who.int/en/news-room/fact-sheets/detail/lassa-fever
(accessed August 4, 2022)7 WHO. Weekly bulletin on outbreaks and
other emergencies.
http://apps.who.int/iris/bitstream/handle/10665/272981/OEW26-2329062018.pdf
(accessed August 4, 2022)
Investor ContactRobert BurrowsVice
President, Investor Relationsburrowsr@ebsi.com(240) 413-1917
Media ContactMatt HartwigSenior
Director, Media Relationsmediarelations@ebsi.com
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