Abstract:
SYN023 is a mixture of two anti-rabies humanized monoclonal IgG1κ antibodies which bind to distinct and non-overlapping antigenic sites on the rabies virus glycoprotein. A Phase 2b and a Phase 3 randomized double-blinded trials were conducted to demonstrate the safety and efficacy of SYN023 in 1448 Category III rabies patients. The analysis of the safety profile of SYN023 based on the integrated data from all 6 clinical trials demonstrated that SYN023 was generally well tolerated when administered alone or with rabies vaccine in subjects with rabies exposure as well as healthy subjects and has a favorable safety profile. SYN023 was considered superior to HRIG with respect to GMC of RVNA on Study Day 8 and noninferior to HRIG with respect to immune response rates on Study Day 99. There were no deaths, serious adverse events, or AEs leading to study discontinuation up to 365 days after dosing. Updated spectrum of neutralization studies and epitope mapping analyses will be discussed. SYN023 was approved in China in June 2024. BLA submissions to the U.S. and other countries are in progress.
Biography:
Dr. Eric Tsao is the CEO and founder of Synermore Biologics, established in 2013. With a background that includes roles at MedImmune and Aeras, he brings extensive experience in biotechnology. Under his leadership, Synermore focuses on developing both innovative and biosimilar products, particularly monoclonal antibodies and other biologics. The company operates internationally, with R&D headquartered in Taipei and additional assets in China, employing around 90 experts.
