mRNA-based COVID-19 vaccine, HGCO19, will soon enrol for phase I and II human clinical trials. To support these trials, Pune-based biotechnology company Gennova Biopharmaceuticals Ltd will receive additional funding from the Ministry of Science & Technology.
The funding has been awarded under the mission COVID Suraksha by the Department of Biotechnology (DBT). The 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 had accepted the vaccine candidate HGCO19.
HGCO19 has already demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models, the statement by the ministry stated.
Gennova has completed two preclinical toxicity studies as per the Drugs 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, the ministry stated.
The company has initiated the process to enrol healthy volunteers for the phase I and II clinical trials.
mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.
Dr. Renu Swarup, Secretary, DBT, and Chairperson, BIRAC said, "At the onset of COVID-19, DBT backed many vaccine development programs, including the mRNA-based COVID-19 vaccine. A year back, this was a new technology and never used for vaccine manufacturing in India. However, believing in the potential of this technology, DBT provided seed funding to Gennova to develop this technology platform amenable to scale-up and production. We are very proud that India’s first mRNA-based COVID-19 vaccine is going to the clinics."
CEO of Gennova Biopharmaceuticals Ltd, Dr. Sanjay Singh, said, “We conducted all required safety assessments of the HGCO19 as per well-defined norms and regulations before the start of the human clinical trial designed to establish the safety and efficacy of the HGCO19. Today, the problem of the SARS-CoV2 illness and the associated appearance of new variants made this disease a moving target. We believe the mRNA-based cutting-edge technology will play an important role in evolving effective solutions."
