— 5-fold greater neutralizing antibodies in opposition to dominant Omicron BA.5 in individuals who acquired SCB-2019 (CpG 1018/Alum) as a heterologous third dose after two doses of inactivated vaccine in comparison with a 3rd dose of inactivated vaccine —
— New Part 3 information underscores the potential position SCB-2019 can play as a heterologous booster in opposition to dominant variants in China and different nations and areas, no matter earlier vaccination or an infection historical past —
SHANGHAI, China, Sept. 20, 2022 (GLOBE NEWSWIRE) — Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a worldwide clinical-stage biotechnology firm growing novel vaccines and biologic therapeutics, as we speak introduced constructive information from its ongoing Part 3 examine evaluating Clover’s SCB-2019 (CpG 1018/Alum) as a common COVID-19 booster vaccine candidate. The info confirmed that SCB-2019 (CpG 1018/Alum) elicited superior ranges of neutralizing antibodies in opposition to the Omicron BA.5 subvariant, the dominant SARS-CoV-2 variant circulating globally as we speak, when administered as a heterologous third dose in individuals who beforehand acquired two doses of an inactivated vaccine in comparison with a 3rd dose of the inactivated vaccine.
“Omicron BA.5 is globally dominant as we speak, representing over 90% of circulating strains, and proof signifies that it has some extent of immune escape,” stated Dr. Nicholas Jackson, President of World Analysis and Growth of Clover. “It is rather encouraging to look at the persistently sturdy immune response in opposition to BA.5 elicited by SCB-2019 throughout populations, constructing foundational proof for SCB-2019’s doubtlessly essential position in addressing the persevering with burden of COVID-19—together with in nations and areas the place inactivated vaccines have been extensively used to this point.”
A booster dose of SCB-2019 (CpG 1018/Alum) in individuals who beforehand acquired two doses of the inactivated vaccine elicited superior neutralizing immune responses in opposition to Omicron BA.5 in comparison with responses in individuals receiving a 3rd dose of the inactivated vaccine. Preliminary analyses in topics with low pre-booster neutralizing antibody ranges (outlined as baseline pre-booster neutralizing antibody titers ≤100 utilizing validated dwell SARS-CoV-2 neutralization assays) confirmed that SCB-2019 (CpG 1018/Alum) elicited a 6.5-fold improve in antibody titers in opposition to Omicron BA.5 relative to pre-booster ranges, with geometric imply titers (GMTs) rising from 37 (pre-booster) to 240 (14 days post-booster). This response was 5-fold greater than the response to the inactivated vaccine today techs booster, which elicited a 1.6-fold improve in antibody titers in opposition to Omicron BA.5 (GMTs: 30 [pre-booster], 48 [14 days post-booster]).
The Omicron BA.5 heterologous booster responses are in keeping with prior information from this Part 3 examine (LINK), which confirmed a equally superior response in opposition to the today techs SARS-CoV-2 prototype, Omicron BA.1 and Omicron BA.2 for SCB-2019 (CpG 1018/Alum), relative to inactivated vaccine. They’re additionally in keeping with beforehand launched outcomes demonstrating the sturdy SCB-2019 (CpG 1018/Alum)-elicited immune responses in opposition to Omicron BA.5 in different populations, together with these receiving a homologous third dose of SCB-2019 (CpG 1018/Alum) and those that had a historical past of SARS-CoV-2 an infection at baseline (LINK). Collectively, these outcomes display a doubtlessly differentiated breadth of neutralization in opposition to the globally dominant Omicron BA.5 subvariant by SCB-2019 (CpG 1018/Alum) vaccination.
These outcomes are a part of a Part 3, double-blind, randomized and managed examine that’s evaluating the protection and immunogenicity of SCB-2019 (CpG 1018/Alum) administered as a booster dose in people who acquired two doses of inactivated vaccine in comparison with third, homologous booster dose of the inactivated vaccine. Clover can be presently enrolling a subcohort evaluating SCB-2019 (CpG 1018/Alum) as a fourth dose booster in people beforehand receiving three doses of the inactivated vaccine in comparison with a fourth, homologous booster dose of the inactivated vaccine. The examine has enrolled over 1,500 grownup and aged individuals within the Philippines to this point.
Clover stays targeted on finishing regulatory submissions to the China Nationwide Medical Merchandise Administration, the European Medicines Company, and the World Well being Group for SCB-2019 (CpG 1018/Alum) within the second half of 2022, whereas concurrently making ready for its commercialization in China and globally.
About SCB-2019 (CpG 1018/Alum)
Using the Trimer-Tag™ know-how platform, Clover developed the SCB-2019 antigen, a stabilized trimeric type of the S-protein (known as S-Trimer™) primarily based on the unique pressure of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavax’s (Nasdaq: DVAX) CpG 1018 superior adjuvant and aluminum hydroxide (alum).
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a worldwide clinical-stage biotechnology firm dedicated to growing novel vaccines and biologic therapeutics. The Trimer-Tag™ know-how platform is a product improvement platform for the creation of novel vaccines and biologic therapies. Clover leveraged the Trimer-Tag™ know-how platform to turn out to be a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to handle the COVID-19 pandemic attributable to SARS-CoV-2.
For extra data, please go to Clover’s web site: www.cloverbiopharma.com and observe the corporate on LinkedIn and Twitter.
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