Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, Wednesday announced their collaboration to initiate a vaccine program for the current coronavirus, COVID-19.
Valneva´s scientific team has tirelessly explored opportunities to rapidly leverage Valneva´s existing technology, capabilities and infrastructure to create a SARS-CoV-2 vaccine candidate in response to the current pandemic.
Valneva is leveraging its well-established platform for IXIARO®, the Company’s commercial vaccine product indicated for active immunization for the prevention of Japanese encephalitis. This platform operates on a highly purified Vero-cell based, inactivated, whole virus strategy for vaccine development.
Dynavax is providing technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a well‑developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.
Valneva will use its Biosafety Level 3 laboratory capabilities to rapidly leverage its large scale, Vero-based, viral Good Manufacturing Practice manufacturing facility in Livingston, Scotland, where both IXIARO® and VLA1553, the Company’s vaccine candidate against chikungunya, are currently manufactured.
Wolfgang Bender, Ph.D., M.D., Chief Medical Officer of Valneva, commented: “Valneva aims to contribute to a world in which no one dies or suffers from a vaccine-preventable disease, such as COVID-19. Although different vaccine technologies are being deployed in the global effort to combat COVID-19, we believe that a proven approach is the best option for rapidly delivering a safe and effective vaccine. The proven approach that we are taking to develop VLA2001 has the potential to yield protection for the general population, as well as high risk groups, including the elderly, immuno-compromised and individuals suffering from other diseases.”
Ryan Spencer, Chief Executive Officer of Dynavax commented: “Now more than ever, the world is feeling the crucial role vaccines play in protecting our families, communities, and those at high risk for infectious disease. Dynavax’s mission is to investigate, innovate, and improve vaccines to provide protection for an unpredictable world. We are pleased to partner with Valneva on this important development effort to address the global health crisis spawned by COVID-19.”
Professor George Siber, MD, Member of Valneva´s Scientific Advisory Board commented: “Although many companies are advancing novel vaccine approaches to develop a vaccine against SARS-COV-2, the Scientific Advisory Board strongly supports this approach. There is a high likelihood that a modern, inactivated SARS-CoV-2 vaccine combined with an adjuvant such as CpG 1018 could be effective and safe.”
Valneva and Dynavax will work with regulatory authorities to align on the optimal strategy to execute an expedited clinical development path, with the goal to initiate clinical trials before the end of 2020.
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