Clover Biopharmaceuticals announced that its bivalent RSV candidate vaccine SCB-1019 has obtained positive clinical data in a head-to-head comparison with GSK's RSV vaccine AREXVY.

PR Newswire · Oct 29 06:30

-- 头对头临床数据表明：未使用佐剂的二价 RSV 候选疫苗 (SCB-1019) 的综合有效性和安全性可达潜在同类最佳 --

-- 三叶草生物未使用佐剂的 SCB-1019 与 GSK 使用 AS01E 佐剂的 AREXVY 在老年人群组中诱导的 RSV 中和抗体水平相当，同时与 GSK 的 AREXVY 相比，三叶草生物未使用佐剂的 SCB-1019 耐受性明显更良好 --

-- 三叶草生物计划于 2025 年启动临床试验，用于评估 SCB-1019 在 RSV 疫苗重复接种以及呼吸道联合疫苗的应用 --

上海2024年10月29日 /美通社/ -- 致力以创新型疫苗拯救生命和改善全球健康水平的处于商业化阶段的全球生物制药公司——三叶草生物制药有限公司（以下简称“三叶草生物”；香港联交所股票代码：02197）今天公布，其在 Ⅰ 期临床试验中评估未使用佐剂的二价 RSV PreF-三聚体亚单位候选疫苗SCB-1019（开发基于三叶草生物独有的 Trimer-Tag--蛋白质三聚体化疫苗技术平台）与 GSK 使用 AS01E 佐剂的 RSV 疫苗 AREXVY 进行头对头比较后，在老年人受试者中获得了更多积极的免疫原性和安全性数据。

“我们高兴地宣布，与 GSK 使用 AS01E 佐剂的 RSV 疫苗 AREXVY 相比，三叶草生物未使用佐剂的RSV 候选疫苗 SCB-1019 获得了积极的头对头临床数据，这表明我们可能有同类最佳的综合有效性和安全性，” 三叶草生物首席执行官兼执行董事梁果先生表示。“虽然目前已获批上市的蛋白质 RSV 疫苗的首剂接种安全有效，但在应对（针对 RSV 病毒感染）保护效力降低需要进行有效的重复接种，以及预防由类似 RSV 结构病毒引起的呼吸道疾病，仍是全球尚未解决且尚未高度满足的需求。我们期待在 2025 年对 SCB-1019 进行 RSV 疫苗重复接种以及呼吸道联合疫苗开发的临床评估。”

在正在进行的 Ⅰ 期临床试验中，70例老年受试者入组了临床试验，分别接种了三叶草生物的 SCB-1019、GSK 的 AREXVY 或生理盐水安慰剂。SCB-1019 的免疫原性和安全性初步数据总结如下：

免疫原性结果

RSV 中和抗体：在第 28 天，未使用佐剂的 SCB-1019 诱导的 RSV-A 和 RSV-B 中和抗体的几何平均滴度 (GMTs) 与使用 AS01E 佐剂的 AREXVY 相当，未观察到显著的统计学差异。

- RSV-A 中和抗体：接种后第 28 天，SCB-1019 诱导的 RSV-A 中和抗体几何平均滴度（GMTs）约为30,500 IU/mL，而 AREXVY组数据约为 26,700 IU/mL，安慰剂组数据约为 3,300 IU/mL。
- RSV-B 中和抗体：接种后第 28 天，SCB-1019 诱导的 RSV-B 中和抗体几何平均滴度（GMTs）约为32,000 IU/mL，而 AREXVY 组数据约为 37,700 IU/mL，安慰剂组数据约为 2,900 IU/mL。

RSV-B 特异性抗体：与 AREXVY（单价 RSV-A）相比，SCB-1019（二价 RSV-A/B）针对强效 RSV-B 特异性中和表位在中和位点 V 的抗体趋势（几何均值比 [GMR]）要高出约 1.5 倍（基于探索性竞争 ELISA 的检测方法），这表明如果在后续研究中得到证实，重复接种后可能会产生更大、更持久的免疫广度。

安全性和反应原性结果

与 GSK 使用 AS01E 佐剂的 RSV 疫苗 AREXVY（76.7%）相比，未使用佐剂的 SCB-1019（16.7%）的局部不良事件（AEs）发生率明显较低。
SCB-1019 的耐受性总体良好。SCB-1019 的局部和全身不良事件（AEs）总体较轻，与生理盐水安慰剂组相当。
未观察到与疫苗相关的严重不良事件（SAEs），特殊关注的不良事件（AESIs）或局部不良事件（AEs）导致的停药。

基于上述积极的 Ⅰ 期临床试验结果，三叶草生物计划将在 2025 年启动临床试验，用于评估 SCB-1019（未使用佐剂的二价 RSV-A/B 候选疫苗）在 RSV 疫苗重复接种以及呼吸道联合疫苗的应用。

关于三叶草生物

三叶草生物是一家处于商业化阶段的全球生物制药公司，致力以创新型疫苗拯救生命和改善全球健康水平。凭借综合研发实力、生产和商业化能力，以及与分布全球的相关机构强大的合作伙伴关系，我们已经开发出多样化的候选疫苗管线，以期我们的疫苗可使更多疾病得到预防，助力减轻公共卫生的负担。

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三叶草生物

企业传播：曹阳
media@cloverbiopharma.com

投资者关系：涂凌飞
investors@cloverbiopharma.com

Head-to-head clinical data shows: The comprehensive efficacy and safety of the bivalent RSV candidate vaccine (SCB-1019) without adjuvant can reach the potential best in class.

Trifolium Biotech's adjuvant-free SCB-1019 is comparable to GSK's AS01E-adjuvanted AREXVY in inducing RSV neutralizing antibody levels in the elderly group, while demonstrating significantly better tolerability compared to GSK's AREXVY.

Trifolium Biotech plans to initiate clinical trials in 2025 to evaluate SCB-1019 in repeated administration of RSV vaccines and in combination with respiratory tract vaccines.

Shanghai, October 29, 2024 / PRNewswire/ - TriClover Biopharmaceuticals, a commercial-stage global biopharmaceutical company dedicated to saving lives with innovative vaccines and improving global health, announced today that in Phase I clinical trials, the adjuvant-free bivalent RSV PreF trimer subunit candidate vaccine SCB-1019 (developed based on TriClover unique Trimer-Tag - protein trimerization vaccine technology platform) was compared head-to-head with GSK's AS01E-adjuvanted RSV vaccine AREXVY, obtaining more positive immunogenicity and safety data in elderly subjects.

“We are pleased to announce that, compared to GSK's RSV vaccine AREXVY using adjuvant AS01E, Clover Biopharmaceuticals' RSV candidate vaccine SCB-1019 without adjuvant has obtained positive head-to-head clinical data, indicating that we may have the best overall effectiveness and safety in its class,” said Mr. Liang Guo, CEO and executive director of Clover Biopharmaceuticals. “Although the first dose of protein RSV vaccine on the market is safe and effective, there is still a global need that has not been fully met for effective repeated vaccinations to address the reduced protective efficacy against RSV virus infection and to prevent respiratory diseases caused by similar RSV-like viruses. We look forward to conducting repeat vaccinations of SCB-1019 for RSV vaccines and evaluating the development of respiratory tract combination vaccines in 2025.”

In the ongoing Phase I clinical trial, 70 elderly subjects were enrolled in the clinical trial and received vaccinations of Clover Biopharmaceuticals' SCB-1019, GSK's AREXVY, or saline placebo. Preliminary data on the immunogenicity and safety of SCB-1019 are summarized as follows:

Immunogenicity Results

RSV Neutralizing antibodies: On day 28, the geometric mean titers (GMTs) of neutralizing antibodies induced by SCB-1019 without adjuvant against RSV-A and RSV-B are comparable to AREXVY with adjuvant, with no significant statistical difference observed.

- RSV-A Neutralizing antibodiesAfter 28 days of vaccination, the geometric mean titer (GMTs) of neutralizing antibodies induced by SCB-1019 against RSV-A is approximately 30,500 IU/mL, while the data for the AREXVY group is around 26,700 IU/mL, and the data for the placebo group is around 3,300 IU/mL.
- RSV-B Neutralizing antibodiesOn day 28 after vaccination, the geometric mean titer (GMTs) of RSV-B neutralizing antibodies induced by SCB-1019 is approximately 32,000 IU/mL, while the data for the AREXVY group is around 37,700 IU/mL, and for the placebo group is around 2,900 IU/mL.

RSV-B Specific antibodiesCompared with AREXVY (monovalent RSV-A), SCB-1019 (bivalent RSV-A/B) shows a trend of approximately 1.5 times higher geometric mean ratio (GMR) for potent RSV-B specific neutralizing epitopes at neutralization site V (based on exploratory competition ELISA detection methods), indicating the potential for greater and more sustained immune breadth upon repeat vaccinations if confirmed in subsequent studies.

Safety and reactogenicity results.

Compared with the RSV vaccine AREXVY (76.7%) using the AS01E adjuvant from GSK, the incidence of local adverse events (AEs) of SCB-1019 (16.7%) without adjuvant was significantly lower.
Overall, the tolerability of SCB-1019 is good. The overall incidence of local and systemic adverse events (AEs) of SCB-1019 is relatively mild and comparable to the physiological saline placebo group.
No vaccine-related serious adverse events (SAEs), events of special interest (AESIs), or discontinuations due to local adverse events (AEs) were observed.

Based on the positive results of Phase I clinical trials mentioned above, Trifolium Biotech plans to initiate clinical trials in 2025 to evaluate SCB-1019 (a bivalent RSV-A/B candidate vaccine without adjuvants) for repeated administration of RSV vaccines and respiratory tract co-vaccination applications.

About Trifolium Biotech

Trifolium Biotech is a globally commercialized biopharmaceutical company dedicated to saving lives and improving global health levels with innovative vaccines. With comprehensive research and development capabilities, production and commercialization capabilities, as well as strong partnerships with relevant institutions distributed globally, we have developed a diverse pipeline of candidate vaccines in the hope that our vaccines can prevent more diseases and help alleviate the burden on public health.

Forward-Looking Statements from Trifolium Biotech

This press release contains several forward-looking statements and information related to us and our subsidiaries, based on the beliefs of our management, assumptions, and information currently available to them. When using words such as "intend," "expect," "believe," "may," "estimate," "anticipate," "outlook," "plan," "potential," "estimate," "forecast," "seek," "should," "will," "shall," and other similar expressions, if referring to us or our management, they are intended to identify forward-looking statements.

Forward-looking statements are based on our current expectations and assumptions about our business, economy, and other future conditions. We do not guarantee that these expectations and assumptions will be realized. Due to the inherent uncertainties, risks, and changes in circumstances involved in forward-looking statements, our performance may differ significantly from the results envisioned by such statements. They are neither statements of historical facts nor guarantees of future performance. Therefore, we caution you not to rely excessively on any such forward-looking statements. Any forward-looking statements made in this document represent our opinions as of the date of this document. Factors or events that may cause our actual performance to differ may arise from time to time, and we may not be able to predict all of these factors or events. In compliance with applicable laws, rules, and regulations, we do not undertake any obligation to update any forward-looking statements due to new information, future events, or other reasons. This cautionary statement applies to all forward-looking statements contained in this document.

Trifolium Bioscience

Corporate Communications: Cao Yang
media@cloverbiopharma.com

Investor Relations: Tu Lingfei
investors@cloverbiopharma.com

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三叶草生物公布其二价 RSV 候选疫苗 SCB-1019 与 GSK RSV 疫苗 AREXVY 头对头比较获得积极临床数据

Clover Biopharmaceuticals announced that its bivalent RSV candidate vaccine SCB-1019 has obtained positive clinical data in a head-to-head comparison with GSK's RSV vaccine AREXVY.

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