Trimer-Tag™ Subunit Vaccines

Clover anticipates commercializing SCB-2019 (CpG 1018/Alum) as one of the first protein-based COVID-19 vaccines globally through the COVAX facility, potentially reducing 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. Because SCB-2019 (CpG 1018/Alum) is stable for at least two months at room temperature and is expected to be stable long term in refrigeration conditions. 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. We are potentially able to produce more than one billion doses of SCB-2019 annually in-house at peak capacity.

Pending positive interim data, we plan to submit conditional regulatory approval applications to the EMA, the NMPA and the WHO in the second half of 2021, and plan to commence product launch by the end of 2021. SCB-2019 (CpG 1018/Alum) is funded by Coalition for Epidemic Preparedness Innovations (CEPI), and will be made available for procurement and allocation through the COVAX Facility. We also intend to supply additional SCB-2019 (CpG 1018/Alum) post conditional approval via bilateral supply agreements with sovereign countries if COVAX does not exercise its right of first refusal to procure doses or if there is additional capacity available.

Leveraging the Trimer-Tag™. technology platform, we are well-positioned to rapidly develop second-generation COVID-19 vaccine candidates to address the emerging variants of concern. Our pre-clinical immunogenicity study in mice indicated that our monovalent South Africa Variant (B.1.351 variant of SARS-CoV-2)-based vaccine candidate could potentially be broadly protective against the currently circulating original SARS-CoV-2 strains and variants of concern.

We are also conducting additional vaccine discovery programs for various other indications, including rabies, RSV, influenza, and HIV, all of which are enveloped RNA viruses that display trimeric spike glycoproteins, a characteristic similar to the SARS-CoV-2 virus.