INOVIO, Advaccine Enter Exclusive COVID-19 DNA Vax Pact
By Contract Pharma Staff | 01.04.21
Partnership adds Asian manufacturing resource to INOVIO's global manufacturing consortium for INO-4800.
Advaccine will have the exclusive right to develop, manufacture and commercialize INO-4800 in Greater China. Advaccine will license its plasmid manufacturing process for use with INO-4800 and other INOVIO pipeline product candidates to INOVIO with the right to sublicense to INOVIO's manufacturing partners.
Advaccine will provide its clinical data to INOVIO in support of INOVIO's global INO-4800 regulatory filings and INOVIO will provide its INO-4800 clinical data for Advaccine to incorporate into its marketing applications in Greater China. INOVIO will receive $3.0 million upfront, and an aggregate of $108.0 million upon the achievement of specified development and sales-based milestones for INO-4800 in Greater China. INOVIO will also receive royalties on sales.
INOVIO and Advaccine have all 640 subjects dosed for the first vaccination in a Phase 2 clinical trial in China. The primary endpoints will evaluate safety and immunogenicity within the Chinese population. The dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels, similar to the independently run Phase 2 segment of INOVIO's Phase 2/3 trial for INO-4800 in the U.S., called INNOVATE.