13 April 2021 | News
Gennova has initiated the process to enrol healthy volunteers from the Phase I/II clinical trials
Image Credit: shutterstock.com
The Department of Biotechnology (DBT), Ministry of Science & Technology has announced that it has approved additional funding towards clinical studies of India's 'first of its kind' mRNA-based COVID-19 vaccine - HGCO19, developed by Pune-based biotechnology company Gennova Biopharmaceuticals.
This funding has been awarded under the 'Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission' by DBT's dedicated Mission Implementation Unit at Biotechnology Industry Research Assistance Council (BIRAC) after multiple rounds of evaluation of all the applications that were submitted in response to the 'Request for Expression of Interest (REOI)' under Mission COVID Suraksha for the'Development of COVID-19 vaccine candidate(s)'.
DBT has been hand-holding Gennova's right from the start and has facilitated establishing Gennova's mRNA-based next-generation vaccine manufacturing platform by providing seed funding for the development of HGCO19. Gennova, in collaboration with HDT Biotech Corporation, USA, has developed the COVID-19 mRNA vaccine – HGCO19.
HGCO19 has already demonstrated safety, immunogenicity, neutralization antibody activityin the rodent and non-human primate models. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19.
Gennova has completed two preclinical toxicity studies as per theDrugs and Cosmetics (Ninth Amendment) Rules - 2019,to establish the safety of the vaccine candidate and got regulatory clearance from the Review Committee on Genetic Manipulation (RCGM) and office of the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), Government of India, to conduct clinical trials. Gennova has initiated the process to enrol healthy volunteers from the Phase I/II clinical trials.