— 5-fold increased neutralizing antibodies towards dominant Omicron BA.5 in members who obtained 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 Phase 3 knowledge underscores the potential position SCB-2019 can play as a heterologous booster towards 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 creating novel vaccines and biologic therapeutics, as we speak introduced optimistic knowledge from its ongoing Phase 3 research evaluating Clover’s SCB-2019 (CpG 1018/Alum) as a common COVID-19 booster vaccine candidate. The knowledge confirmed that SCB-2019 (CpG 1018/Alum) elicited superior ranges of neutralizing antibodies towards the Omicron BA.5 subvariant, the dominant SARS-CoV-2 variant circulating globally as we speak, when administered as a heterologous third dose in members who beforehand obtained two doses of an inactivated vaccine in comparison with a 3rd dose of the inactivated vaccine.
“Omicron BA.5 is globally dominant today, representing over 90% of circulating strains, and evidence indicates that it has some degree of immune escape,” stated Dr. Nicholas Jackson, President of Global Research and Development of Clover. “It is very encouraging to observe the consistently robust immune response against BA.5 elicited by SCB-2019 across populations, building foundational evidence for SCB-2019’s potentially critical role in addressing the continuing burden of COVID-19—including in countries and regions where inactivated vaccines have been widely used to date.”
A booster dose of SCB-2019 (CpG 1018/Alum) in members who beforehand obtained two doses of the inactivated vaccine elicited superior neutralizing immune responses towards Omicron BA.5 in comparison with responses in members 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 towards Omicron BA.5 relative to pre-booster ranges, with geometric imply titers (GMTs) growing from 37 (pre-booster) to 240 (14 days post-booster). This response was 5-fold increased than the response to the inactivated vaccine booster, which elicited a 1.6-fold improve in antibody titers towards Omicron BA.5 (GMTs: 30 [pre-booster], 48 [14 days post-booster]).
The Omicron BA.5 heterologous booster responses are according to prior knowledge from this Phase 3 research (LINK), which confirmed a equally superior response towards the SARS-CoV-2 prototype, Omicron BA.1 and Omicron BA.2 for SCB-2019 (CpG 1018/Alum), relative to inactivated vaccine. They are additionally according to beforehand launched outcomes demonstrating the robust SCB-2019 (CpG 1018/Alum)-elicited immune responses towards Omicron BA.5 in different populations, together with these receiving a homologous third dose of SCB-2019 (CpG 1018/Alum) and people who had a historical past of SARS-CoV-2 an infection at baseline (LINK). Together, these outcomes reveal a doubtlessly differentiated breadth of neutralization towards the globally dominant Omicron BA.5 subvariant by SCB-2019 (CpG 1018/Alum) vaccination.
These outcomes are a part of a Phase 3, double-blind, randomized and managed research that’s evaluating the security and immunogenicity of SCB-2019 (CpG 1018/Alum) administered as a booster dose in people who obtained two doses of inactivated vaccine in comparison with third, homologous booster dose of the inactivated vaccine. Clover can be at present 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 research has enrolled over 1,500 grownup and aged members within the Philippines to this point.
Clover stays targeted on finishing regulatory submissions to the China National Medical Products Administration, the European Medicines Agency, and the World Health Organization for SCB-2019 (CpG 1018/Alum) within the second half of 2022, whereas concurrently getting ready for its commercialization in China and globally.
About SCB-2019 (CpG 1018/Alum)
Employing 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 creating 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 grow to be a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to handle the COVID-19 pandemic brought on by SARS-CoV-2.
For extra info, please go to Clover’s web site: www.cloverbiopharma.com and comply with the corporate on LinkedIn and Twitter.
Clover Forward-looking Statements
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Forward-looking statements are primarily based on our present expectations and assumptions concerning our business, the economy and different future circumstances. We give no assurance that these expectations and assumptions will show to have been right. Because forward-looking statements relate to the long run, they’re participant to inherent uncertainties, dangers and modifications in circumstances which can be troublesome to foretell. Our outcomes might differ materially from these contemplated by the forward-looking statements. They are neither statements of historic reality nor ensures or assurances of future efficiency. We warning you due to this fact towards inserting undue reliance on any of those forward-looking statements. Any forward-looking assertion made by us on this doc speaks solely as of the date on which it’s made. Factors or occasions that would trigger our precise outcomes to vary might emerge on occasion, and it isn’t attainable for us to foretell all of them. Participant to the necessities of relevant legal guidelines, guidelines and rules, we undertake no obligation to replace any forward-looking assertion, whether or not because of new info, future occasions or in any other case. All forward-looking statements contained on this doc are certified by reference to this cautionary assertion.
Clover Biopharmaceuticals:
Albert Liao
Executive Director, Corporate Communications
[email protected]
Elaine Qiu
Director, Investor Relations
[email protected]
