California based immuno-tech company Dynavax Technologies (NASDAQ: DVAX) has partnered with French biotechnology company Valneva SE (OKCMKTS: INRLF) to develop a vaccine for the coronavirus that causes COVID-19. Valneva will contribute manufactured inactivated SARS-CoV-2 virus to the vaccine while Dynavax will include its proprietary immune-stimulating toll-like receptor 9 (TLR9) agonist adjuvant CpG1018.
Valneva will manufacture inactivated whole SARS-CoV-2 virus using its Vero cell-based vaccine platform at its large-scale manufacturing facility in Livingston, Scotland. The Vero cell platform is “well-established” and currently used to produce IXIARO®, “the company’s commercial vaccine product indicated for active immunization for the prevention of Japanese encephalitis.”
Valneva’s vaccine manufacturing process would involve the deactivation of the SARS-CoV-2 virus with beta-propiolactone, a chemical commonly used in vaccine production that would “preserve the native structure of the [spike] S protein,” a structural element of the coronavirus that is involved in the binding to and transmission of the virus into human host cells. The coronavirus spike protein is an important target of neutralizing antibody, which provides protection against infection by the virus.
Dynavax adjuvant CpG1018 is “a well‑developed technology” with “a significant safety database” and is currently used in the recombinant Hepatitis B vaccine HEPLISAV-B®, which is approved by the United States Food and Drug Administration for Hepatitis B vaccination in adults. Vaccine adjuvant is intended to enhance the immune response to the viral antigens and promote the development of protective anti-viral immunity.
The combination of CpG1018 and whole SARS-CoV-2 virus “is expected to induce a strong immune response and has the potential to generate high titers of neutralizing antibodies.”
Chief Medical Officer of Valneva Dr. Wolfgang Bender, PhD, MD, stated, “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,” Dr. Bender continued.
Dynavax’s Chief Executive Officer Ryan Spencer 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.”
Valneva Scientific Advisory Board Member Professor George Siber, MD, stated, “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 intend to initiate clinical trials of the vaccine by the end of 2020 and will “work with regulatory authorities to align on the optimal strategy to execute an expedited clinical development path.”