Inovio has secured approval from Center for Drug Evaluation of the National Medical Products Administration in China to carry out two clinical trials of heterologous prime-boosting with its Covid-19 vaccine candidate, INO-4800.
INO-4800 features a particularly designed deoxyribonucleic acid (DNA) plasmid.
To be injected intradermally with subsequent electroporation, INO-4800 carries the DNA plasmid directly into body cells.
Inovio’s partner, Advaccine Biopharmaceuticals Suzhou, will sponsor the open-label, positive-control trials.
Conducted in partnership with Sinovac Biotechnology, the trials will evaluate the safety, tolerability as well as the immunogenicity of sequential immunisations with a combined regimen of INO-4800 and Sinovac’s inactivated Covid-19 vaccine, CoronaVac.
The World Health Organization (WHO) validated CoronaVac for emergency use.
Expected to commence in the upcoming months, the trials will enrol healthy adults who are aged 18 years and above in China.
The firms found in the cross prime-boost pre-clinical animal trials of the vaccines, that the prime-boost regimen can lead to increased levels of antigen-specific binding antibodies, neutralising antibodies and antigen-specific T cell immune responses.
Inovio president and CEO Dr J Joseph Kim said: “If approved, we believe INO-4800 will be well-positioned to serve the vaccine needs of the global community as both a primary and a booster vaccine due to its tolerability, balanced cross-reactive immune responses and strong thermostability profile that does not require cold or ultra-cold-chain transport.”
In June 2021, Inovio extended collaboration with Advaccine in order to co-perform Phase III part of the ongoing Phase II/III INNOVATE trial.
Initially, this Phase III efficacy part will be conducted in Latin America, Asia and Africa.