Clover Biopharmaceuticals' COVID-19 Vaccine with Dynavax's (DVAX) CpG 1018 Adjuvant Meets All Endpoints in Phase 2/3 Trial

September 22, 2021 7:10 AM EDT

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Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Clover Biopharmaceuticals (Clover) reported positive data for their protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) adjuvanted with Dynavax's CpG 1018 adjuvant, which achieved the primary and secondary efficacy endpoints in SPECTRA, a global pivotal Phase 2/3 clinical trial that enrolled over 30,000 participants. Vaccine efficacy was successfully demonstrated in an environment where 100% of SARS-CoV-2 strains observed in the efficacy analysis were variants.

Clover reported the following data from their Phase 2/3 SPECTRA trial in a press release issued September 22, 2021. SCB-2019 (CpG 1018/Alum) demonstrated 100% efficacy against severe COVID-19 and hospitalizations and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2. SCB-2019 (CpG 1018/Alum) demonstrated 79% overall efficacy against COVID-19 of any severity caused by the globally dominant Delta variant. Efficacy was 92% against the Gamma variant and 59% against the Mu variant, and collectively these three strains (Delta, Gamma and Mu) comprised 73% of all strains identified in the study. Overall efficacy was 67% against COVID-19 of any severity caused by any strain in the study, successfully meeting the primary endpoint of the trial. Clover's vaccine candidate is one of the first to demonstrate significant efficacy against Delta in a double-blind, randomized clinical trial.

SCB-2019 (CpG 1018/Alum) demonstrated a favorable safety profile. Severe and serious adverse events (AEs) were infrequent and balanced between vaccine and placebo groups. Solicited local AEs were mostly mild and transient cases of pain at the injection site and decreased in frequency after the second dose. Importantly, the frequency of solicited systemic AEs monitored (fatigue, headache, muscle pain, joint pain, loss of appetite, nausea, chills, fever), were similar between vaccine and placebo groups.

Ryan Spencer, Chief Executive Officer of Dynavax commented, "We are very pleased with the reported efficacy results demonstrated in the SPECTRA trial, especially considering that all cases were from variants. In addition to the positive efficacy results, the remarkable tolerability profile of the Clover vaccine adjuvanted with CpG 1018 could be a useful tool in overcoming vaccine hesitancy for more reactogenic platforms and for booster doses in the future. We believe these trial results demonstrate the value of our CpG 1018 adjuvant as part of the response to this pandemic and as a platform for the development of new and improved vaccines. We look forward to continuing to support Clover and the development of their COVID-19 vaccine, making it available to those in need around the world."

Additional data from the SPECTRA final analysis have been made available in a presentation that can be found on Clover's corporate website. Clover intends to submit the trial results for peer-reviewed publication.

Clover plans to submit conditional approval applications to global regulatory authorities including China's National Medical Products Administration, the European Medicines Agency, and the World Health Organization (WHO) in the fourth quarter of 2021. Contingent upon receiving a conditional approval, Clover plans to commence initial product launch of SCB-2019 (CpG 1018/Alum) potentially by the end of 2021. Subject to receiving Emergency Use Listing (EUL) from the WHO, Clover plans to supply up to 414 million doses of its COVID-19 vaccine candidate globally through the COVAX Facility as previously announced.

SPECTRA (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine) is Clover's double-blind, randomized, placebo-controlled study of SCB-2019 (CpG 1018/Alum) administered in a two-dose regimen, 21 days apart. Global enrollment surpassed 30,000 participants aged 18 years or older in five countries across four continents resulting in one of the most ethnically diverse COVID-19 clinical trials conducted to date, including 49% of participants from Asia, 45% from Latin America and the remainder from Europe and Africa.



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