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三葉草生物-B：自願公告三葉草生物公布二價RSV候選疫苗SCB-1019 I 期臨床試驗老年人群組獲得積極初步數據

CLOVER BIO-B: VOLUNTARY ANNOUNCEMENTCLOVER ANNOUNCES POSITIVE PRELIMINARYPHASE I RESULTS FOR BIVALENT RSV VACCINE CANDIDATESCB-1019 IN OLDER ADULT AND ELDERLY COHORT

Hong Kong Stock Exchange ·  Jun 18 17:27
Summary by Futu AI
三葉草生物製藥有限公司（「三葉草生物」）宣布其開發的二價RSV候選疫苗SCB-1019在 I 期臨床試驗中，老年人群組（60-85歲）獲得了積極的初步免疫原性和安全性數據。試驗在澳大利亞進行，48名老年受試者接種了SCB-1019或生理鹽水安慰劑。結果顯示，SCB-1019在接種後第28天，對RSV-A和RSV-B的中和抗體幾何平均滴度（GMT）分別高達7,906 IU/mL和46,674 IU/mL，顯著高於安慰劑組。此外，SCB-1019的耐受性良好，未觀察到嚴重不良事件。這些數據支持三葉草生物開發二價RSV-A/B PreF疫苗的策略，並可能在安全性和反應原性方面具有差異化優勢。完整的安全性和免疫原性結果預計將於2024年年底前公布，以支持SCB-1019的進一步開發。
三葉草生物製藥有限公司（「三葉草生物」）宣布其開發的二價RSV候選疫苗SCB-1019在 I 期臨床試驗中，老年人群組（60-85歲）獲得了積極的初步免疫原性和安全性數據。試驗在澳大利亞進行，48名老年受試者接種了SCB-1019或生理鹽水安慰劑。結果顯示，SCB-1019在接種後第28天，對RSV-A和RSV-B的中和抗體幾何平均滴度（GMT）分別高達7,906 IU/mL和46,674 IU/mL，顯著高於安慰劑組。此外，SCB-1019的耐受性良好，未觀察到嚴重不良事件。這些數據支持三葉草生物開發二價RSV-A/B PreF疫苗的策略，並可能在安全性和反應原性方面具有差異化優勢。完整的安全性和免疫原性結果預計將於2024年年底前公布，以支持SCB-1019的進一步開發。
Sanleaf Biopharmaceutical Co., Ltd. ("Sanleaf Biopharmaceutical") announced that its bivalent RSV candidate vaccine SCB-1019 has obtained positive preliminary immunogenicity and safety data in Phase I clinical trial in elderly subjects (aged 60-85 years). The trial was conducted in Australia, with 48 elderly subjects receiving SCB-1019 or placebo saline. The results showed that on the 28th day after administration, the geometric mean titers (GMTs) of neutralizing antibodies against RSV-A and RSV-B were as high as 7,906 IU/mL and 46,674 IU/mL, respectively, significantly higher than those in the placebo group. In addition, SCB-1019 was well tolerated, and no serious adverse events were observed. These data support Sanleaf Biopharmaceutical's strategy of developing a bivalent RSV-A/B PreF vaccine, which may have differentiation advantages in safety and response immunogenicity. The complete safety and immunogenicity results are expected to be released by the end of 2024 to support further development of SCB-1019.
Sanleaf Biopharmaceutical Co., Ltd. ("Sanleaf Biopharmaceutical") announced that its bivalent RSV candidate vaccine SCB-1019 has obtained positive preliminary immunogenicity and safety data in Phase I clinical trial in elderly subjects (aged 60-85 years). The trial was conducted in Australia, with 48 elderly subjects receiving SCB-1019 or placebo saline. The results showed that on the 28th day after administration, the geometric mean titers (GMTs) of neutralizing antibodies against RSV-A and RSV-B were as high as 7,906 IU/mL and 46,674 IU/mL, respectively, significantly higher than those in the placebo group. In addition, SCB-1019 was well tolerated, and no serious adverse events were observed. These data support Sanleaf Biopharmaceutical's strategy of developing a bivalent RSV-A/B PreF vaccine, which may have differentiation advantages in safety and response immunogenicity. The complete safety and immunogenicity results are expected to be released by the end of 2024 to support further development of SCB-1019.
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