China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced additional positive Phase III clinical trial data for its lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal booster shot. The data show that subjects who received SCB-2019 as the third booster, following two doses of inactivated vaccine, exhibited higher levels of neutralizing antibodies against the Omicron BA.5 variant subtype compared to those who received a third dose of inactivated vaccine.
Clinical Trial Results and Significance
Previously, SCB-2019 has demonstrated superior neutralizing antibody levels against the novel coronavirus wild strain and Omicron variant subtypes BA.1 and BA.2. Clover Bio is currently enrolling a sub-cohort to evaluate the effect of SCB-2019 as the fourth booster dose in individuals previously vaccinated with three doses of inactivated vaccine. The trial aims to compare the efficacy of the fourth booster dose of homologous inactivated vaccine. To date, the trial has enrolled over 1,500 adult and elderly subjects in the Philippines.
Regulatory and Commercialization Efforts
Clover will continue to focus on completing the registration application for SCB-2019 with the National Medical Products Administration, the European Medicines Agency, and the World Health Organization in the second half of 2022, while preparing for commercialization in China and globally.
Global Development and Partnerships
SCB-2019 has been developed with funding support from CEPI (the Coalition for Epidemic Preparediness Innovations) and will be eligible for sale and distribution globally through the Global Alliance for Vaccines and Immunisation’s (GAVI) COVAX mechanism. The protein vaccine was developed using Clover’s proprietary Trimer-Tag (protein trimerization) technology, a drug development platform that enables the production of novel, covalently-trimerized fusion proteins. Clover previously partnered with US-based Dynavax Technologies Corporation (NSDQ: DVAX) to provide the CpG 1018 vaccine adjuvant for use with the product.-Fineline Info & Tech
