Clover Biopharmaceuticals Announces Positive Head-to-Head Phase I Data for Adjuvant-Free Bivalent RSV Vaccine SCB-1019 Versus GSK’s AREXVY
GSK
Pharmaceutical R&D Manufacturer
On October 29, 2024, Daoyuan's outstanding invested company, a global biopharmaceutical company ——Sanyecao Bio-pharmaceutical Co., Ltd.(hereinafter referred to as "Sichuan Sanyecao Bio-pharmaceutical Co.,Ltd."; Stock Code: 02197 on the Hong Kong Stock Exchange),Its bivalent RSV PreF-trimer subunit candidate vaccine SCB-1019 without adjuvant was evaluated in Phase I clinical trials.(Development based on Sichuan Sanyecao Bio-pharmaceutical Co., Ltd.'s proprietary Trimer-Tag--protein trimerization vaccine technology platform)Compared head-to-head with GSK's RSV vaccine AREXVY, which uses the AS01E adjuvant, more positive immunogenicity and safety data were obtained in elderly subjects.
❖Head-to-head clinical data shows: The bivalent RSV candidate vaccine (SCB-1019) without adjuvant has demonstrated potentially best-in-class overall efficacy and safety.
❖ Sichuan Sanyecao Bio-pharmaceutical Co.,Ltd.'s SCB-1019 without adjuvant induced RSV neutralizing antibody levels comparable to GSK's AREXVY with AS01E adjuvant in the elderly population, while Sichuan Sanyecao Bio-pharmaceutical Co.,Ltd.'s SCB-1019 without adjuvant showed significantly better tolerability compared to GSK's AREXVY.
❖ Sichuan Sanyecao Bio-pharmaceutical Co., Ltd. plans to initiate clinical trials in 2025 to evaluate the application of SCB-1019 in RSV vaccine booster doses and combination respiratory vaccines.
Clover Biopharmaceuticals CEO and Executive Director, Liang Guo"We are pleased to announce that compared to GSK's RSV vaccine AREXVY using the AS01E adjuvant, our unadjuvanted RSV candidate vaccine SCB-1019 has achieved positive head-to-head clinical data, indicating that we may have the best-in-class combination of efficacy and safety," said Mr. Guo Liang, CEO and Executive Director of Sichuan Sanyecao Bio-pharmaceutical Co., Ltd. "While the first dose of currently approved protein-based RSV vaccines is safe and effective, there remains an unmet global need for effective repeat vaccinations to address waning protection against RSV infections and to prevent respiratory diseases caused by structurally similar viruses. We look forward to clinically evaluating SCB-1019 for RSV booster vaccinations and combined respiratory vaccine development in 2025."
In the ongoing Phase I clinical trial, 70 elderly subjects were enrolled and received either Sichuan Sanyecao Bio-pharmaceutical Co., Ltd.'s SCB-1019, GSK's AREXVY, or a saline placebo. The preliminary data on the immunogenicity and safety of SCB-1019 are summarized below:
01 Immunogenicity Results
RSV Neutralizing Antibody: On Day 28, the geometric mean titers (GMTs) of RSV-A and RSV-B neutralizing antibodies induced by SCB-1019 without adjuvant were compared to those with AS01.EThe AREXVY adjuvant is equivalent, with no significant statistical difference observed.
RSV-A Neutralizing Antibody: On Day 28 post-vaccination, the geometric mean titers (GMTs) of RSV-A neutralizing antibodies induced by SCB-1019 were approximately 30,500 IU/mL, compared to approximately 26,700 IU/mL in the AREXVY group and approximately 3,300 IU/mL in the placebo group.
RSV-B Neutralizing Antibody: On Day 28 post-vaccination, the geometric mean titers (GMTs) of RSV-B neutralizing antibodies induced by SCB-1019 were approximately 32,000 IU/mL, compared to approximately 37,700 IU/mL in the AREXVY group and approximately 2,900 IU/mL in the placebo group.
RSV-B Specific Antibody: Compared with AREXVY (monovalent RSV-A), SCB-1019 (bivalent RSV-A/B) showed an approximately 1.5-fold higher antibody response (geometric mean ratio [GMR]) targeting potent RSV-B specific neutralizing epitopes at neutralization site V (based on exploratory competitive ELISA assays).This suggests that if confirmed in subsequent studies, repeated vaccinations may lead to greater and more sustained immune breadth.
02 Safety and Reactogenicity Results
Compared with GSK's use of AS01ECompared with the adjuvanted RSV vaccine AREXVY (76.7%)The incidence of local adverse events (AEs) for SCB-1019 without adjuvant (16.7%) was significantly lower.
SCB-1019 Was Well Tolerated OverallThe local and systemic adverse events (AEs) of SCB-1019 were generally mild, comparable to those in the saline placebo group.
No serious adverse events (SAEs), adverse events of special interest (AESIs), or discontinuations due to local adverse events (AEs) related to the vaccine were observed.
Based on the positive results from the Phase I clinical trial, Sichuan Sanyecao Bio-pharmaceutical Co., Ltd. plans to initiate a clinical trial in 2025 to evaluate SCB-1019 (a bivalent RSV-A/B candidate vaccine without adjuvant) for repeated RSV vaccination and its application in combination respiratory vaccines.
About Sichuan Sanyecao Bio-pharmaceutical Co.,Ltd.
Sichuan Sanyecao Bio-pharmaceutical Co., Ltd. is a global biopharmaceutical company at the commercialization stage, dedicated to saving lives and improving global health with innovative vaccines. With integrated R&D capabilities, production and commercialization capacity, as well as strong partnerships with relevant institutions worldwide, we have developed a diversified pipeline of vaccine candidates, aiming to make more diseases preventable with our vaccines and help alleviate the burden on public health.
About Daoyuan Capital
DaoYuan Capital is a leading private equity investment institution focused on the healthcare sector, dedicated to helping outstanding healthcare companies grow rapidly by leveraging capital and industry resources, providing better medical products and services to society, and promoting human health.
Currently, Daoyuan Capital manages 19 RMB funds and 4 USD funds, with a total of 90 outstanding projects invested, including 16 IPO projects (one of which has obtained the CSRC registration approval), such as Aier Eye Hospital (301239), Jinxin Fertility (HK.1951), Sinomed Medical (688108), Innovax Biotech (688253), Tinavi Medical Technologies (688277), Viva Biotech (HK.1873), BioPerfectus Technologies (688393), and Angell Technology (688581). As of the present date in 2024, two enterprises have filed for an IPO, and more than 10 invested companies are expected to enter the IPO process within the next three years.
