02197 CLOVER BIOPHARMACEUTICALS LTD

Clover and CEPI Expand Partnership for COVID-19 Vaccine Candidate to Include Evaluation as a Booster

Clover and CEPI Expand Partnership for COVID-19 Vaccine Candidate to Include Evaluation as a Booster

  • CEPI commits up to an additional US$36.9 million for a total investment of up to $397.4 million to support the development of Clover’s COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum)
  • CEPI funding supports development of SCB-2019 (CpG 1018/Alum) for primary vaccination across all age groups (pediatric, adolescent, adults, and elderly) and development as a potential booster

CHENGDU, China and OSLO, Norway, Nov. 18, 2021 (GLOBE NEWSWIRE) -- , a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates, and , the Coalition for Epidemic Preparedness Innovations, today announced that CEPI will provide up to an additional US$36.9 million in funding to support continued development of SCB-2019 (CpG 1018/Alum) through licensure. This brings CEPI’s total potential funding in SCB-2019 (CpG 1018/Alum) up to US$397.4 million, which represents one of CEPI’s largest investments in a COVID-19 vaccine manufacturer to date. Previous CEPI funding has supported preclinical and clinical testing of the vaccine, in addition to scaling up the manufacturing process. Pending WHO Emergency Use Listing (EUL), Clover will supply up to 414 million doses of the vaccine to the COVAX Facility for equitable distribution.

Clover is utilizing the funding from CEPI to develop SCB-2019 (CpG 1018/Alum) as a primary vaccination for all age groups (pediatric, adolescent, adults and elderly) and as a potential booster for previously-infected individuals and populations that have received SCB-2019 (CpG 1018/Alum) for the primary vaccination (homologous booster). In September 2021, Clover announced SPECTRA, a global pivotal phase 2/3 clinical trial evaluating the efficacy, safety, and immunogenicity of SCB-2019 (CpG 1018/Alum) met the primary and secondary endpoints and that a single dose of SCB-2019 (CpG 1018/Alum) in individuals who had previously been infected by SARS-CoV-2 induced a rapid and strong boosting effect on neutralizing antibody titers1. Evaluation of SCB-2019 (CpG 1018/Alum) as a homologous booster will be conducted as an expansion arm of SPECTRA and initiate in the near-term. Clover is also in the process of planning multiple heterologous booster studies with SCB-2019 (CpG 1018/Alum).

“Clover appreciates the continued partnership with CEPI and their support for developing SCB-2019 (CpG 1018/Alum) as a potential COVID-19 booster vaccine. We believe that SCB-2019 (CpG 1018/Alum) is well-positioned to be evaluated as a universal COVID-19 booster vaccine, given the significant efficacy against variants as well as the favorable safety profile demonstrated in the Phase 2/3 SPECTRA trial. If successful, SCB-2019 (CpG 1018/Alum) could be an important tool to provide continued protection against COVID-19 for those most in need globally,” said Joshua Liang, CEO of Clover Biopharmaceuticals.

Dr. Richard Hatchett, CEO of CEPI noted, “While multiple safe and effective COVID-19 vaccines are now available we know that COVID-19 is here to stay, so further R&D is needed to inform vaccination strategies that will help control the virus in the long-term. I’m pleased to further expand CEPI’s R&D partnership with Clover which will maximize the potential impact of this vaccine as we seek to protect those most at risk from COVID-19, wherever they are in the world.”

About SCB-2019 (CpG 1018/Alum)

SCB-2019 (CpG 1018/Alum), Clover’s 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.

For more information, please visit our website: and follow the company on .

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus - it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale, and access. These programmes leverage the rapid response platforms previously developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.

CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at .

Follow our for the latest updates. Follow us on  and .

About the COVAX Facility 

COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, a ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. 

Forward-looking Statements (relating to Clover)

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.

Clover Biopharmaceuticals:

Cindy Min

SVP, Public Affairs

Naomi Eichenbaum

VP, Investor Relations

 

CEPI

Email: 

Phone:

________________________

1  



EN
18/11/2021

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on CLOVER BIOPHARMACEUTICALS LTD

 PRESS RELEASE

Clover Launches Quadrivalent Seasonal Influenza Vaccine in Mainland Ch...

Clover Launches Quadrivalent Seasonal Influenza Vaccine in Mainland China --Clover launches AdimFlu-S (QIS) in mainland China, the only imported quadrivalent seasonal influenza vaccine approved for use in individuals aged three years and older --  --Second commercialized product strengthens Clover’s leading respiratory vaccine franchise and financial profile--  SHANGHAI, China, Sept. 12, 2023 (GLOBE NEWSWIRE) -- (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the worl...

 PRESS RELEASE

 三叶草生物四价季节性流感疫苗在中国大陆上市

 三叶草生物四价季节性流感疫苗在中国大陆上市 --三叶草生物四价季节性流感疫苗在中国大陆上市,这是国内目前唯一获批用于三岁及以上人群的进口四价季节性流感疫苗--  --第二个商业化产品强化了三叶草生物领先的呼吸道疫苗产品组合和财务可持续发展-- 中国上海, Sept. 12, 2023 (GLOBE NEWSWIRE) -- 致力以创新型疫苗拯救生命和改善全球健康水平的处于商业化阶段的全球生物制药公司——(以下简称“三叶草生物”;香港联交所股票代码:02197)今天宣布在中国大陆商业化上市四价季节性流感疫苗,这是国内目前唯一获批用于三岁及以上人群的进口四价季节性流感疫苗。目前,该疫苗已在中国26个省市准入,商业化准备充分。预计从2023年开始,该四价流感疫苗的销售额将增加三叶草生物的收益,并在2024年及以后贡献有意义的增长。 “我们的第二个商业化产品——四价季节性流感疫苗在中国大陆的上市——进一步强化了三叶草生物领先的呼吸道疫苗产品组合,有助于财务可持续发展,于未来贡献有意义的增长”,三叶草生物首席执行官兼执行董事梁果先生表示。“更重要的是,它有助于三叶草生物进一步在自费市场搭建商业化能力,而这将支持我们呼吸道疫苗产品管线协同发展。” 三叶草生物的四价季节性流感疫苗是一种可用于预防流感的四价裂解灭活疫苗。它含有源于四种流感病毒株(两种甲型和两种乙型)的血凝素,无...

 PRESS RELEASE

Clover Provides Updates on Business and R&D Pipeline Development

Clover Provides Updates on Business and R&D Pipeline Development -- Clover’s leading respiratory vaccine franchise to be strengthened from commercial launch of quadrivalent influenza vaccine (AdimFlu-S [QIS]) in mainland China in H2-2023 -- -- Poised to be a leading RSV vaccine player in China with global potential by leveraging validated Trimer-Tag platform and GMP manufacturing capabilities -- -- Resilient cash balance of approximately RMB 1.5 billion as of June 30, 2023 compared to RMB 1.86 billion as of December 31, 2022, with approximately 50% reduction1 in operating expenditures ach...

 PRESS RELEASE

三叶草生物商业化和研发管线的最新进展

三叶草生物商业化和研发管线的最新进展 --伴随2023年下半年四价季节性流感疫苗(AdimFlu-S [QIS])在中国大陆的商业化,三叶草生物领先的呼吸道疫苗产品组合强势发力-- --利用已经验证的Trimer-Tag技术平台和GMP生产能力,三叶草生物有望成为中国领先的且具有全球潜力的呼吸道合胞病毒(RSV)疫苗厂商-- --截至2023年6月30日,充沛的现金余额约为15亿人民币,而截至2022年12月31日为18.6亿人民币,与2022年上半年相比,2023年上半年实现了约50%运营支出减少1;预计未来12个月内,将继续保持运营效率提高的趋势-- 中国上海, July 11, 2023 (GLOBE NEWSWIRE) -- 致力以创新型疫苗拯救生命和改善全球健康水平的处于商业化阶段的全球生物制药公司——(以下简称“三叶草生物”;香港联交所股票代码:02197)今天公布了商业化和研发管线的最新进展。 三叶草生物首席执行官兼执行董事梁果先生表示:“自2023年初以来,三叶草生物在建立领先的呼吸道疫苗产品组合方面取得了重大进展,增加了一个商业化阶段的四价季节性流感疫苗,并着力推进RSV疫苗,该疫苗正在利用已经验证的蛋白质三聚体化(Trimer-Tag)平台进行开发。同时,我们还采取了一些重大举措,例如通过疫苗销售获得营收、提高运营效率和保持弹性的现金状况等,以...

 PRESS RELEASE

Clover Announces Corporate Updates and Full Year 2022 Financial Result...

Clover Announces Corporate Updates and Full Year 2022 Financial Results -- Clover’s two premium respiratory vaccines approved in China (COVID-19 and seasonal influenza) are expected to drive meaningful and diversified revenues in 2023 with continued growth thereafter -- -- Clover’s COVID-19 vaccine now listed in 24 provinces and municipalities in China (representing >80% population coverage) and well-positioned to be a major player in upcoming vaccination campaigns; anticipated to receive emergency use authorization (EUA) and sign a bilateral supply agreement in at least one additional cou...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch