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 GAPIII[2] 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.

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.”

Über Valneva SE

Valneva 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 Biosciences

Batavia 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-Fontaine

Director of Investor Relations &

Corporate Communications

M +33 (0)6 4516 7099

investors@valneva.com

Batavia Biosciences

Chris Yallop

COO

T +31 (0)88 9950600

c.yallop@bataviabiosciences.com

 

Zukunftsgerichtete Aussagen

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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.