Leiden, Netherlands and Saint-Herblain,
France, June 15, 2020 – Batavia Biosciences (“Batavia”)
and Valneva Sweden AB, the Swedish subsidiary of Valneva SE
(“Valneva”), today announced that they have entered into a
collaboration agreement to accelerate market-access of a low-cost
inactivated polio vaccine (IPV). This work is supported under
GPEI.1
In 2019, Batavia received a grant from the Bill
& Melinda Gates Foundation to use its novel, low-cost vaccine
manufacturing process HIP-Vax™, in combination with Nevoline™
manufacturing equipment developed by Univercells, to deliver
clinical grade IPV bulks to selected Developing Country Vaccine
Manufacturers (DCVMs) for phase I/II clinical studies. The IPV
vaccine is based on the Sabin vaccine strains (sIPV), which Batavia
has successfully obtained from the World Health Organization
(WHO).
Under the terms of the agreement, Valneva will
manufacture the sIPV vaccine for clinical trial purposes in its
state-of-the-art GMP polio manufacturing facility operated under
GAPIII2 polio containment in Solna, Sweden, using Batavia’s
process. In return, Valneva will receive an upfront payment and
monthly service fees.
Batavia will remain responsible for release and
supply of the GMP vaccine to the DCVMs. The know-how generated will
be made available to the DCVMs to facilitate transfer of the
technology and manufacture of the vaccine under GAPIII conditions
in the future.
Batavia will remain responsible for release and
supply of the GMP vaccine to the DCVMs. The know-how generated will
be made available to the DCVMs to facilitate transfer of the
technology and manufacture of the vaccine under GAPIII conditions
in the future.
Thomas Lingelbach, CEO, Valneva,
commented, “As a company focusing on high unmet medical
needs, Valneva is proud to make another important contribution to
polio eradication through this agreement with Batavia. Our site and
team in Sweden has significant experience working with poliovirus.
This new contract underscores Valneva’s technical expertise in
clinical manufacturing and bio-risk management.”
Chris Yallop, COO, Batavia Biosciences,
added, “We are excited to be working with Valneva, who can
leverage their GAPIII polio facility and polio know-how to
accelerate the development of this important vaccine as well as
offering an important step forward in the application of our
HIP-Vax™ technology for vaccine manufacture.”
About Valneva SEValneva is a
specialty vaccine company focused on prevention against 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 unique vaccines against Lyme disease and
chikungunya. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the US with over 500 employees.
For more information, visit www.valneva.com and follow the
Company on LinkedIn.
About Batavia
BiosciencesBatavia Biosciences significantly contributes
to ease human suffering from infectious diseases and cancer by
improving the success rate in the translation of candidate
medicines from discovery to the clinic. We offer our innovative
technologies and in-depth know-how in order to help our partners to
complete preclinical phases in biopharmaceutical product
development at higher speed, reduced costs and increased success.
The company focuses on the early stages of product development
including cell line generation, upstream process development,
purification development, product characterization and clinical
manufacturing. Headquartered in Leiden, the Netherlands, with a
subsidiary in Woburn, Massachusetts, and offices in Hong Kong,
Batavia Biosciences is privileged to have strong strategic partners
worldwide.
Investor and Media Contacts
Valneva Laetitia Bachelot-FontaineDirector of
Investor Relations & Corporate CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
Batavia
BiosciencesChris YallopCOOT +31 (0)88
9950600c.yallop@bataviabiosciences.com |
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the progress,
timing and completion of research, development and clinical trials
for product candidates, the ability to manufacture, market,
commercialize and achieve market acceptance for product candidates,
the ability to protect intellectual property and operate the
business without infringing on the intellectual property rights of
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other things, uncertainties involved in the development and
manufacture of vaccines, unexpected clinical trial results,
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1 The Global Polio Eradication Initiative is a
public-private partnership led by national governments with six
core partners - the World Health Organization (WHO), Rotary
International, the US Centers for Disease Control and Prevention
(CDC), the United Nations Children’s Fund (UNICEF), the Bill &
Melinda Gates Foundation and Gavi, the Vaccine Alliance. Its goal
is to eradicate polio worldwide.2 The Global Action Plan, third
edition (GAPIII) was established by the World Health Organization
in December 2014 to minimize the risk of reestablishing the
circulation of poliovirus from potentially infectious samples
stored in facilities, including laboratories.
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