By Daniel Webster, dWeb.News Publisher
November 25, 2021 19: 30 ET | Source: Clover Biopharmaceuticals
The Phase 2 trial is an investigator initiated study, sponsored by the Instituto D’Or de Pesquisa e Ensino (IDOR) and funded by the Bill & Melinda Gates Foundation
The study will evaluate the immunogenicity and safety of SCB-2019 in approximately 520 healthy adult participants at multiple sites in Brazil
Initial safety and immunogenicity data are anticipated in the first half of 2022
CHENGDU, China, Nov. 26, 2021 (GLOBE NEWSWIRE) — Clover Biopharmaceuticals, Ltd. (“Clover”; Stock code: 2197.HK), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced that an investigator-led, Phase 2 trial initiated 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 assessed as a heterologous booster dose in individuals previously vaccinated with either CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz).
The Phase 2 trial is an investigator initiated study, sponsored by IDOR with funding from the Bill & Melinda Gates Foundation and supported by the Brazilian Ministry of Health. The study is a double blind, randomized, controlled design that will be conducted in two stages. Stage one will evaluate three formulations of SCB-2019 (9µg with alum, 9µg with CpG 1018/alum, and 30µg with CpG 1018/alum), administered as a booster dose, approximately 6 months after the primary vaccination with recombinant Covid-19 vaccine (AstraZeneca/Fiocruz). The purpose of this stage is to define the optimal vaccine formulation in comparison to a homologous booster of recombinant Covid-19 vaccine (AstraZeneca/Fiocruz). Stage two will evaluate the immunogenicity and safety of a booster dose of selected SCB-2019 formulation in individuals previously vaccinated with 2 doses of either CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz). Homologous boosters of CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz) will be used as controls.
The study is anticipated to enroll approximately 520 healthy adult participants in multiple study locations in Brazil. Safety and immunogenicity data are expected in the first half of 2022 and the results will be published as guidance for optimizing booster dose regimens.
Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals said, “We are excited to learn how our COVID-19 vaccine candidate performs as a booster dose for people previously vaccinated with either inactivated or adenovirus-vectored COVID-19 vaccines. SPECTRA trial data (reported in September 2021) showed that vaccination with SCB-2019 (CpG 1018/Alum) in individuals previously-infected by SARS-CoV-2 demonstrated a rapid and strong boosting effect on neutralizing antibody titers, as well as a favorable safety profile, thus supporting the evaluation of our COVID-19 vaccine candidate as a potential booster vaccine. We want to thank the Brazilian Ministry of Health and the Institutional Review Bords for their guidance and the opportunity to participate in this trial, the Bill & Melinda Gates Foundation for funding the study and IDOR for sponsoring the study.”
Prof. Dr. Sue Ann Costa Clemens, CBE, Oxford Vaccine Group Director, Brazil Unit and Principal Investigator of the grant stated, “Booster doses are being widely used to ensure high protection against variants and durability of immunity. That increases the demand for vaccines. Clover is exploring new possibilities on higher protection and higher production capacity. The protein based vaccines will add a new perspective to the public health needs with regards to the COVID-19 booster demands.”
About SCB-2019 (CpG 1018/Alum)
SCB-2019 (CpG 1018/Alum), our COVID-19 vaccine candidate, is anticipated to potentially be one of the first protein-based COVID-19 vaccines commercialized globally through the COVAX Facility. Employing the Trimer-Tag technology platform, Clover developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein (referred to as 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).
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates. The Trimer-Tag technology platform is a product development platform for the creation of novel vaccines and biologic therapies. Clover leveraged the Trimer-Tag technology platform to become a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to address the COVID-19 pandemic caused by SARS-CoV-2.
Clover Forward-looking Statements
This press release contains certain forward-looking statements and information relating to us and our subsidiaries that are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this [document], the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative of these words and other similar expressions, as they relate to us or our management, are intended to identify forward-looking statements.
Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. We give no assurance that these expectations and assumptions will prove to have been correct. Because forward-looking statements relate to the future, they are participant to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against placing undue reliance on any of these forward-looking statements. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. Participant to the requirements of applicable laws, rules and regulations, we undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements contained in this document are qualified by reference to this cautionary statement.
SVP, Public Affairs
VP, Investor Relations
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