Michelle Wang

Executive Director of Business Development at Frontera Therapeutics

Presenter

Frontera is a clinical-stage biotech company dedicated to bringing innovative, high-quality, affordable rAAV gene therapies to patients worldwide. We have built a world-class drug development team with R&D center in Boston (USA), clinical operation center in Shanghai (China), and GMP manufacturing facilities in Suzhou (China). Our work is backed by global top-notch academic & clinical experts (SAB) and funded by the renowned venture capitals of ObiMed, Hongshan, Boyu, Creacion etc. We have built a rich gene therapies pipeline to address both prevalent and rare diseases in ophthalmology, hematology and cardiology. Our core asset, FT-003 (anti-VEGF) is developed for nAMD and DME patients through IVT injection and is in China Phase 2 . With the differented and optimized vector design, FT-003 showed superior efficacy and safety (vs. main competitors) in its IIT & Phase 1 studies. FT-002 is at China Phase 2 and is the only clinical-stage AAV product for XLRP due to high R&D barrier. The IIT & Ph1 data showed "Best in Class" potential vs. competitors. FT-001 for LCA2 is ready for China Phase 3 with promising data. Our R&D center (in Boston) has established a robust technology platform, TRACTOR, for AAV capsids and gene expression cassette engineering. Through a comprehensive screening process, we have secured patent-protected AAV vectors that offer precise tissue targeting, more durable gene transduction, and potentially lower immunogenicity. Frontera has developed the next-generation production platform, AAVANCE, using Sf9 insect cell-baculovirus expression vector system (Sf9 BEVS) and operates a state-of-the-art AAV GMP manufacturing facility in Suzhou. Our robust, scalable production and purification processes achieve an industry-leading yields >1E15 vg/L while establishing a new benchmark for low empty capsid rate <1%. By significantly reducing the cost of goods sold (COGS) >90%, our manufacturing platform enables greater patient access and affordability.