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 AS01_E-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.