CEPI awards up to US$23.4 million to Valneva for
late-stage development of a single-dose Chikungunya
vaccine
Oslo, Norway, and Saint-Herblain,
France, July 25, 2019—Valneva SE (“Valneva”), a biotech
company developing and commercializing vaccines for infectious
diseases with major unmet needs, and the Coalition for Epidemic
Preparedness Innovations (CEPI) hereby announce a new partnering
agreement. With support from the European Union’s (EU’s) Horizon
2020 programme, CEPI will provide Valneva up to US$23.4 million for
vaccine manufacturing and late-stage clinical development of a
single-dose, live-attenuated vaccine (VLA1553) against Chikungunya.
In line with CEPI’s committment to equitable access, the funding
will underwrite a partnership effort to accelerate regulatory
approval of Valneva’s single-dose Chikungunya vaccine for use in
regions where outbreaks occur and support WHO prequalification to
facilitate broader access in lower and middle income countries.
Valneva will also maintain a stockpile of the
vaccine candidate and work to transfer the secondary manufacturing
of the drug product to partners for lower and middle income
countries—where outbreaks of Chikungunya have occurred—to improve
access to the vaccine for at-risk populations.
The investment is part of CEPI’s third call for
proposals, launched earlier this year with support from the EU’s
Horizon 2020 research and innovation programme under grant
agreement No. 857934.1 Since the launch of this call in January
2019, over US$66 million has been invested in two Chikungunya
vaccine candidates and two RVF vaccine candidates.
Chikungunya virus was first identified in
Tanzania in 1952, with sporadic outbreaks of the disease reported
subsequently across Africa and Asia.2,[3] In 2004, the disease
began to spread quickly, causing large-scale outbreaks around the
world. Since the re-emergence of the virus, the total number of
cases has been estimated at over 3.4 million in 43 countries.4 As
such, the World Health Organization (WHO) has highlighted
Chikungunya as a major public health risk.5
Chikungunya is spread by the bites of infected
female Aedes mosquitoes and causes fever, severe joint pain, muscle
pain, headache, nausea, fatigue and rash. Joint pain is often
debilitating and can persist for weeks to years.6
Climate change could further amplify the threat
posed by Chikungunya. As the climate warms, more areas across the
world will become habitable for the mosquito vectors that transmit
the virus, thereby increasing the size of the human population at
risk of infection. For example, in 2007, an outbreak of Chikungunya
virus infections was declared for the first time in Europe with
more than 200 human cases reported in Italy.7 Since 2014, in the
USA, local-transmission of the virus has been reported in Florida,
Puerto Rico, and the U.S. Virgin Islands.8
Dr Richard Hatchett, CEO of CEPI said:
“Millions of people have been affected by
Chikungunya and, today, over a billion people live in areas where
Chikungunya outbreaks occur. Despite the large outbreaks and
significant consequences of this disease, there is currently no
specific antiviral drug treatment nor are any vaccines licenced for
human use against this virus. Through our partnership with Valneva,
we hope to speed up the development of a Chikungunya vaccine,
ensure that the people most affected by this virus can benefit from
this product, and by doing so help to alleviate the burden of this
debilitating disease. ”
Thomas Lingelbach, CEO of Valneva said:
“Valneva is delighted to announce this
partnership with CEPI. Chikungunya infection is a major unmet
medical need and we believe that our single-shot vaccine is
uniquely positioned to provide optimal protection in all outbreak
situations for people living in areas where Chikungunya occurs and
also for travelers to these regions. We continue to invest heavily
in the program and look forward to working with CEPI on the
project. We plan to enter the pivotal study phase of our vaccine as
soon as possible in close alignment with the US FDA, with the aim
of an accelerated approval.”
—ENDS—
About CEPICEPI is an innovative
partnership between public, private, philanthropic, and civil
organisations launched in Davos in 2017 to develop vaccines to stop
future epidemics. CEPI has received multi-year funding from Norway,
Germany, Japan, Canada, Australia, and the Bill & Melinda Gates
Foundation, and Wellcome. CEPI has also received single-year
investments from the Government of Belgium and the United Kingdom.
The European Union provides financial support for relevant projects
through their Horizon 2020 programme as well as through the
European and Developing Countries Clinical Trials Partnership. CEPI
has reached over US$750 million of its $1 billion funding target.
Since its launch in January 2017, CEPI has announced three calls
for proposals. The first call was for candidate vaccines against
Lassa virus, Middle East Respiratory Syndrome coronavirus
(MERS-CoV), and Nipah virus. The second call was for the
development of platforms that can be used for rapid vaccine
development against unknown pathogens. The third call is for
candidate vaccines against Chikungunya and Rift Valley fever
viruses. To date, CEPI has committed to investing over $413 million
in vaccine development. This includes 18 vaccine candidates against
its priority pathogens (six against Lassa virus, five against
MERS-CoV, three against Nipah virus, two against Chikungunya, two
against Rift Valley fever) and three vaccine platforms to develop
vaccines against Disease X. To assess the effectiveness of these
platforms 7 additional vaccine candidates are being developed (two
against influenza, one against Marburg virus, two against Rabies
virus, one against Respiratory Syncytial Virus, and one against
yellow fever).
Learn more at CEPI.net. Follow us at
@CEPIvaccines.
About ValnevaValneva is a
biotech company developing and commercializing vaccines for
infectious diseases with major unmet needs. Valneva’s portfolio
includes two commercial vaccines for travelers: IXIARO®/JESPECT®
indicated for the prevention of Japanese encephalitis and DUKORAL®
indicated for the prevention of cholera and, in some countries,
prevention of diarrhea caused by ETEC. The Company has various
vaccines in development including a unique vaccine against Lyme
disease. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the US with approximately 480
employees. More information is available at www.valneva.com.
Media contacts:
CEPIRachel Grant, Director of
Communications and Advocacy: +44(0)7891249190 |
Rachel.Grant@cepi.net
Mario Christodoulou, Communications and Advocacy Manager:
+44(0)7979300222 | Mario.Christodoulou@cepi.net
Valneva Laetitia
Bachelot-Fontaine, Global Head of Investor Relations &
Corporate Communications: +33 (0)6 4516 7099 |
investors@valneva.com
Teresa Pinzolits, Corporate Communications
Specialist: +43 (0)1 20620 1116 | communications@valneva.com
1
https://cepi.net/news_cepi/cepi-launches-call-for-proposals-to-develop-vaccines-against-rift-valley-fever-and-chikungunya-viruses/
2
https://www.who.int/news-room/fact-sheets/detail/chikungunya
3
https://academic.oup.com/jid/article/214/suppl_5/S441/2632641
4 https://cmr.asm.org/content/31/1/e00104-16
5 https://www.who.int/blueprint/priority-diseases/en/
6 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
7https://ecdc.europa.eu/en/chikungunya/threats-and-outbreaks/chikungunya-fever-eueea
8 https://www.cdc.gov/chikungunya/geo/united-states.html
- 2019_07_25_VLA_CEPI_PR_EN_Final