INOVIO, a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, and Advaccine Biopharmaceuticals Suzhou Co., Ltd. (“Advaccine”), an emerging biotech company with next-generation technology in vaccines – both preventive and therapeutic, announced the successful dosing of its first subject in its Phase 2 clinical trial for COVID-19 DNA vaccine candidate, INO-4800, in China. The Phase 2 clinical trial being conducted in China is independent of the INNOVATE Phase 2/3 clinical trial of INO-4800 being advanced in the U.S. and will enroll approximately 640 participants who are 18 years or older. Advaccine is conducting and funding the Phase 2 trial in China, which is expected to fully enroll by the end of this month.
Dr. J. Joseph Kim, President and CEO of INOVIO, said, “We have accelerated the development of INO-4800, our DNA vaccine candidate for COVID-19, in China by working together and leveraging Advaccine’s expertise with Chinese regulatory authorities and clinical trial management. We are grateful for our collaboration with Advaccine and its founder Dr. Bin Wang, China’s premier DNA vaccine expert and Emeritus Professor from Fudan University. Our teams are pleased with the progress to date and our ability to accelerate our clinical work in China with the goal of developing and delivering a safe, tolerable, effective and lasting vaccine for COVID-19.
Dr. Bin Wang, Founder of Advaccine, said, “We are truly grateful for Advaccine to co-develop INO-4800 against COVID-19 with INOVIO’s team around the clock since January of this year, having maintained a very close collaboration together. INOVIO’s great advantage of rapid DNA plasmid and delivery technologies are very important to the success of this vaccine candidate. After the completion of dosing for Phase 1 trial subjects at Huashan Hospital in Shanghai, China, with regulatory approval, Advaccine quickly launched the Phase 2 clinical trial with Jiangsu Provincial CDC team. With the support of Fengcai ZHU, MD the principle investigator and a well-known vaccine clinical professor and his excellent team members as well as advanced clinical trial infrastructure in Jiangsu Province, I believe we can achieve China Phase 2 enrollment target of 640 subjects by the end of 2020.”
INOVIO and Advaccine have been working together to advance the clinical development of INO-4800 in China. The Phase 2 clinical trial of INO-4800 in China will enroll both 18-59 years old adults 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 and is similar to the Phase 2 segment of Phase 2/3 clinical trial in U.S. This trial in China will provide valuable insights on INO-4800 safety and immunogenicity profile to support further evaluation of this vaccine candidate.
INOVIO recently announced it has dosed the first subjects in the Phase 2 segment of its Phase 2/3 clinical trial for INO-4800 in the U.S., called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy).