13 December 2023 | Wednesday | News
Image Source : Public Domain
Clover Biopharmaceuticals, Ltd. a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, 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.