--First Chinese RSV PreF Vaccine Candidate to Enter Clinical Trial Stage--
SHANGHAI, Dec. 13, 2023 /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 first-in-human study evaluating the company's RSV PreF-Trimer subunit vaccine candidate (SCB-1019), which is based on Clover's Trimer-Tag vaccine technology platform.
"We are pleased to be the first vaccine company based in China developing an RSV prefusion-stabilized F (PreF) vaccine to enter the clinical trial stage establishing our leadership position in the space, which demonstrates the value of our validated Trimer-Tag platform and capabilities of our R&D team," said Joshua Liang, Chief Executive Officer and Board Director of Clover, "RSV vaccines remain a high unmet medical need, especially in China where no domestic RSV PreF vaccines have entered the clinical stage to-date, but also globally where there is opportunity for differentiation."
SCB-1019 is a bivalent RSV-A/RSV-B vaccine candidate based on the prefusion-stabilized F (PreF) protein leveraging the validated Trimer-Tag platform and proprietary stabilizing PreF mutations. The Phase Ⅰ clinical trial in Australia is a randomized, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of SCB-1019 at multiple dose levels and in different formulations in young and older adults. Safety and immunogenicity results are expected by the second half of 2024.
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, and it is not possible for us to predict all of them. Participant to the requirements of applicable laws, rules and regulations, we undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements contained in this document are qualified by reference to this cautionary statement.
