Clover Biopharmaceuticals, a global clinical-stage biotechnology company committed to developing transformative biologics as vaccines and therapeutics for the world's most debilitating diseases, today announced that the data from its Phase 1 clinical trial evaluating the safety and immunogenicity of its protein-based adjuvanted S-Trimer COVID-19 vaccine candidates was published in the peer-reviewed journal, The Lancet.
The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. Objectives were to assess the safety, reactogenicity and immunogenicity of different dose levels of Clover's protein-based S-Trimer vaccine candidates when combined with either Dynavax Technologies Corporation advanced adjuvant CpG 1018 plus alum or GlaxoSmithKline plc pandemic adjuvant system. The candidate vaccines were given in two doses, three weeks apart.
The study found that Clover's adjuvanted S-Trimer COVID-19 vaccine candidates were well tolerated and safe. No serious adverse events related to the vaccine candidates studied were reported. Both vaccines induced high levels of neutralizing antibodies comparable to or exceeding levels in human convalescent sera as well as a strong Th1-biased cell-mediated immunity.
The S-Trimer vaccine candidates and adjuvants are expected to be stable long term at refrigerator temperatures (2-8 oC) and have demonstrated stability at room temperature for at least two months, making these constructs suitable for broad global distribution based on current results.
Dr. Ralf Clemens, Chairman of the Scientific Advisory Board for Clover's COVID-19 Vaccine Program said, "This phase 1 dose-finding and adjuvant justification study demonstrated the potential of Clover's adjuvanted vaccine candidates to bring added value to the global portfolio of COVID-19 vaccines. In both adults and elderly subjects, the vaccine candidates were safe and elicited cellular immune responses and high neutralizing antibody titers with a favorable ratio of neutralizing/binding antibodies. These findings give confidence that Clover's COVID-19 vaccine candidates are suitable for further clinical development."
Based on the preclinical data showing protection against SARS-CoV-2 challenge in two animal species, the positive Phase 1 clinical trial results and scale-up manufacturing considerations, Clover plans to initiate a global Phase 2/3 study to evaluate the safety and efficacy of S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's advanced adjuvant CpG 1018 plus alum within the next few months. The Coalition for Epidemic Preparedness Innovations (CEPI) has committed to fund Clover's S-Trimer COVID-19 vaccine candidate through licensure with a total investment of up to $328 million, a portion of which will support the global Phase 2/3 study.
About S-Trimer COVID-19 Vaccine Candidate
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.
About Trimer-Tag© Technology
Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. Clover is using its Trimer-Tag© technology with global IP position to develop recombinant trimerized fusion proteins that are able to effectively target these previously undruggable pathways.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on disco...
(All Rights Reserved)