Clover and Dynavax Announce Commercial Supply Agreement of Dynavax's CpG 1018 Adjuvant for Clover's COVID-19 Vaccine Candidate
- Clover to procure CpG 1018 adjuvant from
Dynavaxfor use in the commercial production of Clover's COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum)
- Pending conditional regulatory approvals, Clover expects to commence product launch of SCB-2019 (CpG 1018/Alum) by the end of 2021
Clover separately announced today an advanced purchase agreement with Gavi, the
"Throughout the development of our COVID-19 vaccine candidate,
About SCB-2019 (CpG 1018/Alum)
SCB-2019 (CpG 1018/Alum), Clover's COVID-19 vaccine candidate, is anticipated to be one of the first commercialized protein-based COVID-19 vaccines 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 (S-Trimer) based on the original strain of the SARS-CoV-2 virus. Clover's COVID-19 vaccine candidate is the combination of SCB-2019 and two adjuvants,
Clover is currently advancing SPECTRA, a global pivotal Phase 2/3 clinical trial evaluating the efficacy, safety, and immunogenicity of SCB-2019 (CpG 1018/Alum), and expects interim data for vaccine efficacy around the middle of 2021. Pending positive interim data, Clover plans to submit conditional regulatory approval applications to the EMA, the NMPA and the WHO in the second half of 2021, and plans to commence product launch by the end of 2021.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates to address the world's most life-threatening diseases and public health threats. The Trimer-Tag© technology platform is a product development platform for the creation of novel vaccines and biologic therapies. We have leveraged the Trimer-Tag© technology platform to become a COVID-19 vaccine developer and potentially one of the first companies to commercialize a protein-based COVID-19 vaccine globally through the COVAX Facility. For more information, please visit our website: www.cloverbiopharma.com and follow the company on LinkedIn.
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.
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About CpG 1018
CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the
Dynavax Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine containing CpG 1018, the timing and amount of potential sales to Clover and the timing of regulatory approvals. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of initiating clinical trials and completing development, whether CpG 1018 plus aluminum combined with Clover's protein subunit vaccine will prove to be beneficial in clinical trials, whether and when the vaccine will be approved for use, whether CEPI will continue to fund the Clover program through development and licensure, whether or how much Gavi or other commercial customers purchase from Clover, and whether sufficient quantities of CpG 1018 will be able to be manufactured, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended
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SOURCE Clover Biopharmaceuticals