China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study. The study will assess the safety and immunogenicity of SCTV01E-2, an S trimer protein vaccine developed to combat COVID-19. This vaccine is designed for individuals over three years old who have completed basic immunization or received booster shots and is effective against both Beta and Omicron variants.
Sinocelltech’s COVID-19 Vaccine Pipeline
Sinocelltech is advancing multiple COVID-19 variant-targeted recombinant protein vaccines based on its CHO cell production platform technology. In addition to SCTV01E-2, the company is developing SCTV01C and SCTV01E. SCTV01C contains recombinant S-trimer protein antigens of the Alpha and Beta variants recognized by the WHO. SCTV01E is an upgraded version of the 4-valent modified vaccine, incorporating S-trimer protein antigens of the Delta and Omicron BA.1 variants.
SCTV01E-2: An Upgraded Vaccine Candidate
SCTV01E-2 builds on SCTV01E by retaining the S-trimer protein antigens of the Beta and Omicron BA.1 variants and replacing the Alpha and Delta variants with the S-trimer protein antigen of the current predominant strains BQ.1.1 and XBB.1. This modification aims to enhance the vaccine’s relevance and broad-spectrum effectiveness against the current major epidemic strains and their sub-variants.
Production and Adjuvant Details
SCTV01E-2 and SCTV01E share the same production process, molecular design basis, and clinical dosage. Both vaccines utilize a new type of water-in-oil adjuvant that significantly enhances Th1 cell response compared to traditional aluminum adjuvants. SCTV01C and SCTV01E were included in the emergency use list in China in December 2022 and March 2023, respectively. SCTV01E has completed Phase III protective efficacy and safety studies, with major results available.-Fineline Info & Tech
