Trimer-Tag™ Subunit Vaccines

Clover anticipates commercializing SCB-2019 (CpG 1018/Alum) to potentially reduce the global shortage of COVID-19 vaccines and capturing a significant market share of the approximately 15 billion COVID-19 vaccine doses required through 2026. SCB-2019 (CpG 1018/Alum) is expected to be stable under standard refrigeration (2-8°C) storage and transportation conditions. Therefore it is a potentially preferable and a more cost-effective solution for global distribution by leveraging existing and conventional infrastructure, a necessity when transporting to remote and low-resource regions.

As published in The Lancet, in our Phase 1 clinical trial, SCB-2019 (CpG 1018/Alum) induced high neutralizing antibody titers and Th1-biased cell-mediated immune responses, implying a balanced immune response. SCB-2019 (CpG 1018/Alum) demonstrated a favorable safety profile with no serious vaccine-related adverse events and few moderate-to-severe local and systemic adverse events.

In September 2021, SCB-2019 (CpG 1018/Alum) achieved the primary efficacy endpoint and secondary efficacy endpoints in SPECTRA. Based on the SPECTRA results, SCB-2019 (CpG 1018/Alum) demonstrated 100% efficacy against severe COVID-19, 100% efficacy against hospitalizations due to COVID-19, and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2 in SPECTRA. Against the Delta variant, SCB-2019 (CpG 1018/Alum) demonstrated 79% efficacy against COVID-19 of any severity in SPECTRA. SCB-2019 (CpG 1018/Alum) also had a favorable safety profile in SPECTRA with no significant differences in systemic solicited adverse events or severe/serious adverse events compared to placebo. Moreover, SCB-2019 (CpG 1018/Alum) was the first COVID-19 vaccine candidate to demonstrate a significantly reduced risk of COVID-19 in previously infected individuals.

We plan to submit conditional regulatory approval applications for the China NMPA and the EMA and the WHO, with product launches commencing thereafter upon receiving conditional approvals.