Genexine COVID-19 vaccine GX-19N, phase 2/3 IND approved at Indonesia.
[2021/07/07] Genexine(KQ095700) announced their COVID-19 vaccine GX-19N’s phase 2/3 IND is approved by Indonesian FDA, BPOM(BPOM; Badan Pengawas Obat dan Makanan).
This is the very first IND approval case as a Korean vaccine development company to get phase 2/3 approval outside of Korea for COVID-19 Vaccines. Starting from Indonesia, Genexine is planning to conduct multinational collaborative clinical studies as many as 10 thousand healthy adult participants. The company will confirm the efficacy from 10 thousand participants as stage 1 and plans to expands to 30 thousands. The study will be conducted multiple sites including FKUI (Fakultas Kedokteran Universitas Indonesia).
Indonesia has population of 275 million which put it on 4th highest population in the world. The company anticipates recruitment of clinical study will not be difficult, since Indonesian daily infection cases spiked over 29 thousand due to the delta variant.
Genexine recently signed a deal with PT Kalbe Farma for supplying 10 million doses of DNA vaccine. Instead of receiving upfront contract fee, both companies agreed to share the Indonesian part of the global clinical trial cost..
They will evaluate safety of the vaccine at first 300 recruitments and phase 3 study will be started continuously. Phase 3 trial will evaluate the vaccine’s protective efficacy from comparison study of 50% vaccinated participants against 50% placebo. They can get approval if they could have at least 60% protective efficacy data from the trial.
GX-19N, developed by Genexine consortium including GeNbio, Binex, SL Vaxigen, Postech, International Vaccine Institute and KAIST, is DNA platform vaccine which is targeting spike and nucleocapsid protein antigens simultaneously. In result, GX-19N is inducing broad and strong T cell immunity which is expected to be effective against original SARS-CoV-2 and also its variants.
Genexine has evaluated the vaccine’s safety from the phase 1 and 2 studies which was and being conducted in Korea. GX-19N’s safety profile was promising from recent study result with very low mild adverse events such as fatigue, muscle pain and headaches, as well as systemic adverse reported very low which dispelling recent concerns about other vaccines’ severe adverse events such as blood cloth. Currently phase 2a is being carried out against 150 healthy adults and recently the vaccination of the 150 people was completed in Korea.