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Clover Initiates Phase I Clinical Trial for RSV + hMPV ± PIV3 Respiratory Combination Vaccine Candidates

PR Newswire (美通社)

更新於 6小時前 • 發布於 7小時前 • PR Newswire

-- Potential First-in-Class Respiratory Combination Vaccine Candidates SCB-1022 (RSV + hMPV) and SCB-1033 (RSV + hMPV + PIV3) Enter the Clinical Trial Stage --

SHANGHAI, June 17, 2025 /PRNewswire/ -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, today announced that enrollment of the first participants has been completed in a Phase I clinical trial evaluating SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) respiratory combination vaccine candidates based on prefusion-stabilized F (PreF)-Trimer subunit vaccine antigens utilizing Clover's Trimer-Tag vaccine technology platform.

"We are pleased to announce the Phase I clinical trial initiation of our potential first-in-class combination vaccine candidates SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3), further demonstrating the differentiated value of our validated Trimer-Tag platform," said Joshua Liang, Chief Executive Officer & Board Director of Clover. "While currently approved protein-based RSV vaccines are safe & effective, critical gaps persist globally, including the inability to prevent significant respiratory disease burden caused by other viruses related to RSV such as human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3). Thus, we look forward to the clinical trial results for our respiratory combination vaccine candidates in order to maximize our impact on public health globally."

In October 2024, Clover announced Phase I results in 70 older adults (60-85 years) for Clover's non-adjuvanted RSV PreF vaccine candidate (SCB-1019) compared head-to-head to GSK's AS01E-adjuvanted RSV vaccine (AREXVY), and results indicated a potential best-in-class combined immunogenicity & tolerability profile of SCB-1019. These results supported the further development and evaluation of SCB-1019 in combination with the PreF-Trimer antigens for hMPV and PIV3, which are also utilizing the Trimer-Tag platform.

The ongoing Phase I trial for Clover's combination vaccine candidates is enrolling up to 192 older adults (60-85 years), and the participants will be randomized to receive either SCB-1022 (RSV+hMPV), SCB-1033 (RSV+hMPV+PIV3) or SCB-1019 (RSV) comparator. The study will assess safety, reactogenicity and immunogenicity.

About Clover

Clover Biopharmaceuticals is a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing and commercial capabilities as well as strong partnerships with organizations globally, Clover has a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable. 

Clover Forward-looking Statements

This press release contains certain forward-looking statements and information relating to us and our subsidiaries that are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used, the words "aim," "anticipate," "believe," "could," "estimate," "expect," "going forward," "intend," "may," "might," "ought to," "plan," "potential," "predict," "project," "seek," "should," "will," "would" and the negative of these words and other similar expressions, as they relate to us or our management, are intended to identify forward-looking statements. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. We give no assurance that these expectations and assumptions will prove to have been correct. Because forward-looking statements relate to the future, they are participant to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against placing undue reliance on any of these forward-looking statements. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time.

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