Today techs Clover’s Common COVID-19 Booster Vaccine Candidate

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            — 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.

today techs style=”padding-left:0pt;”>Clover Ahead-looking Statements
This press launch incorporates sure forward-looking statements and knowledge referring to us and our subsidiaries which might be primarily based on the beliefs of our administration in addition to assumptions made by and knowledge presently out there to our administration. When used, the phrases “purpose,” “anticipate,” “imagine,” “might,” “estimate,” “count on,” “going ahead,” “intend,” “could,” “would possibly,” “should,” “plan,” “potential,” “predict,” “undertaking,” “search,” “ought to,” “will,” “would” and the damaging of those phrases and different comparable expressions, as they relate to us or our administration, are meant to determine forward-looking statements.

Ahead-looking statements are primarily based on our present expectations and assumptions concerning our enterprise, the financial system and different future circumstances. We give no assurance that these expectations and assumptions will show to have been appropriate. As a result of forward-looking statements relate to the longer term, they’re participant to inherent uncertainties, dangers and adjustments in circumstances which might be troublesome to foretell. Our outcomes could today techs differ materially from these contemplated by the forward-looking statements. They’re neither statements of historic reality nor ensures or assurances of future today techs efficiency. We warning you due to this fact in opposition to 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. Elements or occasions that might trigger our precise outcomes to vary could emerge sometimes, and it’s not potential for us to foretell all of them. Participant to the necessities of relevant legal guidelines, guidelines and laws, we undertake no obligation to replace any forward-looking assertion, whether or not on account of new data, 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
Government Director, Company Communications
media@cloverbiopharma.com

Elaine Qiu
Director, Investor Relations
traders@cloverbiopharma.com

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