Under the collaboration and license agreement, Advaccine will have the exclusive right to develop, manufacture and commercialize INO-4800 within Greater China, inclusive of Mainland China, Hong Kong, Macao, and Taiwan.
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.
Additionally, 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.
Advaccine will make to INOVIO an upfront payment of $3.0 million as well as pay an aggregate of $108.0 million upon the achievement of specified development and sales-based milestones for INO-4800 in Greater China.
INOVIO will be entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region within Greater China.
INOVIO and Advaccine have been working together to advance the clinical development of INO-4800 in China, having all 640 subjects dosed for the first vaccination in Phase 2 clinical trial in China.
The Phase 2 clinical trial of INO-4800 in China has enrolled both adults who are 18-59 years old and older adults (60 years and older) with the primary endpoints of evaluating 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 clinical trial for INO-4800 in the U.S, called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy).
INOVIO also recently announced it has started dosing of subjects in the Phase 2 segment of INNOVATE.
In the planned Phase 3 segment of the trial, INOVIO intends to enroll healthy men and non-pregnant women 18 years and older, to evaluate the efficacy of the proposed dosing level(s) for each age group based on the data from the Phase 2 evaluation. Participants will be enrolled in a one-to-one randomization to receive either INO-4800 or a placebo.
The Phase 3 segment will be case-driven with the final number of enrollees to be determined by the incidence of COVID-19 during the Phase 3 segment. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease. ■