Clover Biopharmaceuticals and Dynavax Technologies announced the plan to initiate a global Phase 2/3 efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover's COVID-19 vaccine candidate and will fund the development, including the Phase 2/3 trial, through licensure.
In its Phase 1 clinical trial, Clover's protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles. Clover 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.
"Given the encouraging results of our adjuvanted S-Trimer COVID-19 vaccine candidate to-date, we are enthusiastic about progressing to a global Phase 2/3 efficacy study utilizing 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," Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, said.
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"We are excited to be rapidly progressing to an efficacy trial to support filing for emergency use and approval. 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. We are proud to be collaborating with Clover on the development of this vaccine for COVID-19 and committed to supporting Clover in making the vaccine available globally," Ryan Spencer, Chief Executive Officer of Dynavax, said.
"To end the acute phase of this pandemic, and to control the virus in the longer term, the world needs multiple safe and effective vaccines which can be deployed in a range of populations and countries. Clover's vaccine candidate has the potential to be manufactured at scale and stored in a regular refrigerator which makes it suitable for use around the globe, including in low-resource settings. Through this partnership we hope to make hundreds of millions of doses of this vaccine globally accessible through COVAX, if it is proven to be safe and effective," Dr. Richard Hatchett, Chief Executive Officer of CEPI, said.
Clover and GSK also decided to discontinue their partnership to evaluate the S-Trimer COVID-19 vaccine candidate with GSK's pandemic adjuvant system.
Utilizing Clover's proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system. S-Trimer is intended to be adjuvanted.