November 25, 2021, 19:30 US Eastern Time | Source: Clover Biopharmaceuticals
Chengdu, China, November 26, 2021 (Global News Agency) - Clover Biopharmaceuticals, Ltd. ("Clover"; stock code: 2197.HK), a global clinical stage biotechnology company developing new vaccines and biotherapeutic drug candidates, An investigator-led Phase 2 trial was announced today to evaluate the immunogenicity and safety of heterologous and homologous COVID-19 booster vaccines. Clover's COVID-19 vaccine candidate SCB-2019 (CpG 1018/Alum) will be evaluated as a heterologous booster dose for individuals who have previously received CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz).
The second phase of the trial is a study initiated by researchers, sponsored by IDOR, funded by the Bill and Melinda Gates Foundation, and supported by the Brazilian Ministry of Health. The study is a double-blind, randomized, controlled design, and will be conducted in two phases. In the first phase, three formulations of SCB-2019 (9µg and alum, 9µg and CpG 1018/alum and 30µg and CpG 1018/alum) will be evaluated, and they will be given as a booster approximately 6 months after the initial inoculation of recombinant Covid-19 vaccine. Medicine (AstraZeneca/Fio Cruz). The purpose of this phase is to determine the best vaccine formulation compared to the homologous booster of the recombinant Covid-19 vaccine (AstraZeneca/Fiocruz). The second phase will assess the immunogenicity and safety of the booster dose of the selected SCB-2019 preparation in individuals who have previously received 2 doses of CoronaVac or the recombinant Covid-19 vaccine (AstraZeneca/Fiocruz). CoronaVac or a homologous booster of the recombinant Covid-19 vaccine (AstraZeneca/Fiocruz) will be used as a control.
The study is expected to recruit approximately 520 healthy adult participants at multiple research sites in Brazil. Safety and immunogenicity data are expected to be released in the first half of 2022, and the results will be published as guidelines for optimizing the enhanced dose regimen.
Joshua Liang, CEO of Clover Biopharmaceuticals, said: “We are pleased to understand how our COVID-19 vaccine candidate can be used as a booster dose for people who have previously been vaccinated with inactivated or adenoviral vector COVID-19 vaccine. SPECTRA trial data (reported in September 2021 ) Showed that SCB-2019 (CpG 1018/Alum) vaccination in individuals previously infected with SARS-CoV-2 showed a rapid and strong promotion of neutralizing antibody titers and a favorable safety profile, thus supporting our evaluation COVID-19 vaccine candidate as a potential booster vaccine. We would like to thank the Brazilian Ministry of Health and the Institutional Review Board for their guidance and participation in this trial, the Bill and Melinda Gates Foundation for funding this research, and IDOR’s sponsorship This research."
Professor Sue Ann Costa Clemens, CBE, Director of the Oxford Vaccine Group, the Brazilian Department and the lead researcher of the grant said: “Booster doses are being widely used to ensure a high degree of protection against mutations and durability of immunity. This increases Vaccine needs. Clover is exploring new possibilities for higher protection and higher production capacity. Protein-based vaccines will add new perspectives to public health needs in terms of COVID-19 booster needs."
SCB-2019 (CpG 1018/Alum) is our COVID-19 vaccine candidate and is expected to be one of the first protein-based COVID-19 vaccines to be commercialized globally through COVAX facilities. Using the Trimer-Tag™ technology platform, Clover developed the SCB-2019 antigen, which is a stable form of S protein trimer (called S-Trimer™), based on the original strain of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide (alum).
Clover Biopharmaceuticals is a global clinical stage biotechnology company dedicated to the development of new vaccines and biotherapeutic drug candidates. The Trimer-Tag™ technology platform is a product development platform for the development of new vaccines and biological therapies. Clover used the Trimer-Tag™ technology platform to become a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to respond to the COVID-19 pandemic caused by SARS-CoV-2.
For more information, please visit Clover's website: www.cloverbiopharma.com and follow the company on LinkedIn.
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Cindy Min Senior Vice President of Public Affairs media@cloverbiopharma.com
Naomi Eichenbaum Vice President, Investor Relations Investors@cloverbiopharma.com