Clover Biopharmaceuticals Announces Positive Phase I Clinical Results for Its SCB-2019 (S-Trimer) COVID-19 Vaccine Candidate Published in The Lancet

CHENGDU, China, Feb. 1, 2021 /PRNewswire/ -- A global clinical-stage biopharmaceutical company focused on developing innovative biological therapies and vaccines for serious diseases worldwide --Clover Biopharmaceuticals, Ltd.(hereinafter referred to as “Clover Biopharmaceuticals”) today announced that its “S-Trimer” recombinant protein subunit COVID-19 candidate vaccine, when administered with an adjuvant, demonstrated favorable safety and immunogenicity in Phase I clinical studies, with these positive results published in a peer-reviewed journalThe Lancet。

The Phase I clinical study is a randomized, observer-blinded, placebo-controlled trial involving 150 adult and elderly subjects, who will receive two doses of the candidate vaccine three weeks apart. The study aims to evaluate the safety, reactogenicity, and immunogenicity at multiple dose levels of the “S-Trimer” recombinant protein subunit COVID-19 candidate vaccine when administered in combination with either the CpG 1018 adjuvant plus aluminum adjuvant from Dynavax Technologies Corporation (hereinafter referred to as “Dynavax,” NASDAQ: DVAX) or the pandemic preparedness vaccine adjuvant system from GlaxoSmithKline (hereinafter referred to as “GSK,” London Stock Exchange: GSK).

The study results indicated that Clover Biopharmaceuticals’ “S-Trimer” COVID-19 candidate vaccine, when combined with two different adjuvants respectively, demonstrated favorable safety and tolerability profiles, with no serious adverse events related to the study vaccines observed. Meanwhile, both COVID-19 candidate vaccines induced high levels of neutralizing antibodies, which were equal to or higher than those observed in the serum of convalescent patients.AndExhibits a pronounced Th1-biased cellular immune response.

“S-Trimer” COVID-19 candidate vaccine and its adjuvant combination can remain stable for extended periods under refrigerated conditions (2–8°C) and maintain stability for at least two months at room temperature, making them suitable for global distribution.

The Scientific Advisory Board (SAB) of Clover Biopharmaceuticals' COVID-19 Vaccine ProjectDr. Ralf Clemens stated, “The results from the Phase I dose-exploratory study and the adjuvant selection fit-for-purpose study demonstrate that Clover Biopharmaceuticals’ COVID-19 candidate vaccine, when used in combination with an adjuvant, adds significant value to the global portfolio of COVID-19 vaccines. The candidate vaccine was safe in both adult and elderly subjects, elicited high neutralizing antibody titers, exhibited a favorable ratio of neutralizing to binding antibodies, and induced cellular immune responses. These findings give us confidence that Clover Biopharmaceuticals’ COVID-19 candidate vaccine is suitable for further clinical development.”

Preclinical studies have demonstrated that Clover Biopharmaceuticals’ COVID-19 candidate vaccine conferred protection in two animal challenge studies against SARS-CoV-2. Based on positive Phase I clinical trial results and scalable manufacturing capabilities, Clover Biopharmaceuticals plans to initiate global Phase II/III clinical trials in the coming months to further evaluate the safety and efficacy of its “S-Trimer” COVID-19 candidate vaccine when co-administered with Dynavax’s CpG 1018 adjuvant plus aluminum salt. The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to fund the development of Clover Biopharmaceuticals’ “S-Trimer” COVID-19 candidate vaccine through to regulatory approval, with total funding reaching up to $328 million, including support for pivotal global Phase II/III clinical efficacy trials.