Pennsylvania Developed COVID-19 Vaccine Candidate Expands Study in China
A biotechnology company 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 will enroll approximately 640 participants who are 18 years or older.
INOVIO and Advaccine Biopharmaceuticals Suzhou Co., Ltd. announced in a press release on December 10, 2020, 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 the USA.
Composed of an optimized DNA plasmid, the INO-4800 vaccine is delivered directly into cells in the body via a proprietary smart device to produce a robust, safe, and tolerable immune response.
INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year, at 37o C for more than a month, has a 5-year projected shelf life, and does not need to be frozen during transport or storage, which are important considerations when preparing for mass immunizations.
Dr. Bin Wang, Founder of Advaccine, said, "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.”
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 USA, called INNOVATE (NCT04642638).
The lead Principal Investigator for INNOVATE is Dr. Pablo Tebas, Professor of Medicine at the Hospital of the University of Pennsylvania. The Phase 2 segment of the clinical trial is designed to evaluate the safety, tolerability, and immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in a three-to-one randomization (in a planned total of 400 subjects) to receive either INO-4800 or placebo, to confirm the more appropriate dosing level for each of three age groups (18-50 years, 51-64 years and 65 years and older) for the subsequent Phase 3 efficacy evaluation.
The INNOVATE trial is funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense in coordination with the Office of the Assistant Secretary of Defense for Health Affairs, and the Defense Health Agency.
In the 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. 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.
INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.
Advaccine Biopharmaceuticals Suzhou Co., Ltd. is an emerging clinical-stage immunotherapy company pioneering novel preventive and therapeutic vaccines against infectious diseases, cancers, and autoimmune diseases.
INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV.
PrecisionVaccinations published research-based vaccine development news.