Clover Biopharmaceuticals Ltd (Clover; HKEX: 02197), a China-based global commercial-stage biotechnology company, announced on Sunday that it has received IND approval from USFDA for its SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilised F (PreF)-Trimer subunit vaccine candidate based on Clover's Trimer-Tag vaccine technology platform.

The company has also completed enrolment of the first participants in a phase one revaccination clinical trial of SCB-1019.

The ongoing Phase I revaccination trial in the US is enrolling up to 160 older adults (60-85 years) who previously received an initial dose of GSK's RSV vaccine (AREXVY) at least 2 seasons prior, and participants will be randomised to receive either a heterologous revaccination dose of SCB-1019, a homologous AREXVY revaccination dose or saline placebo. The study will assess safety, reactogenicity and immunogenicity. Evaluation of SCB-1019 as part of a respiratory combination Trimer-Tagged PreF vaccine (RSV + hMPV ± PIV3) is also on track for Phase I clinical trial initiation in 2025.