Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine
Saint-Herblain (France) and Emeryville (U.S.), September 14, 2020 – Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced a commercial partnership for the supply of Dynavax’s CpG 1018 adjuvant for use in Valneva’s SARS-CoV-2 vaccine candidate, VLA2001. Valneva separately announced today an agreement with the UK government to provide up to 190 million doses of VLA20011 over a five year period. Dynavax will supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase up to an additional 90 million doses through 2025.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are pleased to partner with Dynavax on the further development and future commercialization of our COVID-19 vaccine. We believe that CpG 1018 will add significant value to the target product profile of our vaccine including its intended use in at risk populations. This agreement marks another step in our approach to find a safe and effective solution to address the virus that is continuing to have an impact on us all.”
Ryan Spencer, Chief Executive Officer of Dynavax, commented, “Dynavax is proud to be working with Valneva to support development and commercialization of an adjuvanted vaccine candidate to prevent COVID-19. We are pleased to extend our current partnership to include commercial supply of CpG 1018, our advanced adjuvant. We believe CpG 1018 may play a critical role in the development of a safe and effective vaccine, including potentially enhancing the immune response for those who are traditionally less responsive to vaccination and are at greatest risk for severe disease from COVID-19.”
Valneva expects VLA2001 to enter clinical studies by the end of 2020 and to potentially reach regulatory approval in the second half of 2021.
This commercial supply partnership follows Valneva and Dynavax’s initial collaboration to advance COVID-19 vaccine development, announced in April 20202.
VLA2001 is a Vero-cell based, highly purified inactivated vaccine candidate against the SARS-CoV-2 virus, leveraging the manufacturing technology for Valneva’s Japanese encephalitis vaccine. The Company has designed a process that largely uses this platform in regards to upstream- and downstream process steps as plug-and-play with moderate adjustments. The process includes inactivation with BPL to preserve the native structure of the S protein. The combination with CpG 1018 is expected to induce a strong immune response and has the potential to generate high titers of neutralizing antibodies as well as a polarized Th1 response. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees centigrade).
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