COVID-19 update | Gennova's indigenous mRNA vaccine HGCO19 gets nod for Phase I, II human trials
The firm has received conditional permission for Phases 1 and 2 human clinical trials. The subject expert committee has reviewed its proposal before giving the conditional nod.
December 12, 2020 / 07:16 AM IST
COVID-19 vaccine (representative image)
The Drug Controller General of India (DCGI) on December 12 approved the Phase I and II human clinical trial initiation for indigenous mRNA vaccine candidate HGCO19. The vaccine has been developed by Pune-based firm Gennova Biopharmaceuticals, the Ministry of Science and Technology stated.
Earlier, Gennova had claimed that its first messenger ribonucleic acid (mRNA) platform-based vaccine remained stable at 2-8 degrees Celsius.
The firm has received conditional permission for Phases 1 and 2 human clinical trials. The subject expert committee (SEC) has deliberated on its proposal before giving the conditional nod.The way ahead for COVID-19 vaccine development and distribution in India
The firm had submitted the application for clinical trial permission along with data from the animal toxicity study. However, the SEC observed that only after submitting the interim results of the Phase 1 study that the firm can proceed to the next phase trial. The DCGI has given permission for Phase I and II trials on similar conditions, Business Standard quoted.
For developing the vaccine, the Indian pharma firm has collaborated with Seattle-based HDT Biotech Corporation and received seed funding from the Department of Biotechnology.