China’s Clover Biopharmaceuticals is spurning GlaxoSmithKline’s adjuvant vaccine technology in favor of one created by California-based Dynavax Technologies.
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China’s Clover Biopharmaceuticals is spurning GlaxoSmithKline’s adjuvant vaccine technology in favor of one created by California-based Dynavax Technologies.
This morning, Clover announced it will initiate a Phase II/III study of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of this year. The company anticipates an interim analysis for vaccine efficacy potentially in the middle of 2021.
The decision follows positive Phase I results that assessed the vaccine candidate using adjuvanted technologies from both GSK and Dynavax. Clover said both performed well and high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles. In the end though, Clover opted to move forward with Dynavax. As a result of that decision, Clover and GSK opted to discontinue their partnership for vaccine development.
The company did not provide details regarding the decision to terminate its partnership with GSK, nor did it offer information regarding the clinical differences between the different adjuvant products.
The use of an adjuvant can reduce the amount of vaccine protein required per dose. That in turn allows more vaccine doses to be produced and contributes to protecting more people. Additionally, an adjuvant can enhance the immune response and has been shown to create a stronger and longer-lasting immunity against infections.
GSK’s pandemic adjuvant system is being assessed in multiple COVID-19 vaccine programs, including with Sanofi, Vir Biotechnology and China’s Innovax. In May, GSK pledged to manufacture 1 billion doses of its adjuvant technology as part of its commitment to boosting efforts to develop vaccine candidates against COVID-19.
Regarding the decision to move forward with Dynavax, Joshua Liang, chief executive officer of Clover Biopharmaceuticals, said given the encouraging results of his company’s adjuvanted S-Trimer COVID-19 vaccine candidate to-date, Clover is enthusiastic about progressing to a global Phase II/III efficacy study using Dynavax’s advanced adjuvant CpG 1018 plus alum.
We believe this vaccine candidate could be efficacious while potentially having a differentiated, beneficial reactogenicity and safety profile which could make it attractive for a broad population of peoples. We will continue to work closely with our collaborators and regulatory authorities worldwide to help make our vaccine accessible to those most in need as quickly as possible,” Liang said in a statement.
If the Phase II/III study continues to demonstrate potency against COVID-19, Clover said it expects to produce hundreds of millions of vaccine doses in 2021 and up to 1 billion vaccine doses in peak annual production as required by global demand.
Dynavax CEO Ryan Spencer said his company is proud to collaborate with Clover and is committed to supporting the development of the vaccine. He noted that in the Phase I study, Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response.
The Clover study is financially supported by the Coalition for Epidemic Preparedness Innovations (CEPI).
