Clover Biopharmaceuticals Announces Positive Phase I Head-to-Head Data for Adjuvant-Free Bivalent RSV Vaccine SCB-1019 Versus GSK’s Arexvy
GSK
Pharmaceutical R&D Manufacturer
October 29, 2024 /PRNewswire/ -- A global biopharmaceutical company at the commercial stage dedicated to saving lives and improving global health through innovative vaccines ——Sanyecao Bio-pharmaceutical Co., Ltd.(hereinafter referred to as "Sichuan Sanyecao Bio-pharmaceutical Co.,Ltd."; Stock Code: 02197) announced today,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 with GSK's use of AS01EAfter a head-to-head comparison with GSK's adjuvanted RSV vaccine AREXVY, more positive immunogenicity and safety data were obtained in elderly subjects.
Sanyecao Bio
Liang Guo
Sanyecao Bio
Chief Executive Officer and Executive Director
"We are pleased to announce,Used AS01 with GSKE Compared with GSK's adjuvanted RSV vaccine AREXVY, Sichuan Sanyecao Bio-pharmaceutical Co., Ltd.'s non-adjuvanted RSV candidate vaccine SCB-1019 obtained positive head-to-head clinical data.This suggests that we may haveBest-in-class comprehensive efficacy and safety,"Mr. Guo Liang, CEO and Executive Director of Sichuan Sanyecao Bio-pharmaceutical Co., Ltd., said, 'Although the first dose of currently approved protein RSV vaccines is safe and effective,..."However, addressing the need for effective repeat vaccinations due to reduced protection efficacy against RSV virus infections, as well as preventing respiratory diseases caused by viruses with structures similar to RSV, remains an unresolved and largely unmet global demand.We look forward to the clinical evaluation of SCB-1019 for RSV vaccine booster shots and the development of a combined respiratory vaccine in 2025."
In the ongoing Phase I clinical trial, 70 elderly subjects were enrolled in the clinical trial 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 trend (geometric mean ratio [GMR]) in antibodies 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 vaccination may lead to a greater and more sustained breadth of immunity.
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 generally well-tolerated.The overall local and systemic adverse events (AEs) of SCB-1019 were mild.Comparable to the saline placebo group.
No serious adverse events (SAEs), adverse events of special interest (AESIs), or local adverse events (AEs) leading to discontinuation were observed in relation to the vaccine.
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.
