Pune-based Gennova Biopharmaceuticals has initiated the enrolment of volunteers for Phase 1/2 clinical trials for its mRNA vaccine candidate HGCO19, said the Department of Biotechnology, which has provided seed funding for its development, on April 13.

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The DBT said it has approved additional funding towards clinical studies of India's first of its kind' mRNA-based COVID-19 vaccine, HGCO19, developed by the biotechnology company. The funding has been provided under the DBT's 'Mission COVID Suraksha The Indian COVID-19 Vaccine Development Mission'. It is being implemented by DBT's public sector undertaking Biotechnology Industry Research Assistance Council (BIRAC). "The DBT has been hand-holding Gennova right from the start and has facilitated establishing its 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-19mRNA vaccine HGCO19, the DBT said.

The move augurs well for India as it could give the country, which has been witnessing a massive surge in coronavirus cases combined with concerns of a shortage of vaccines from states, another option to battle the pandemic. The Indian drug regulator has also granted permission for the restricted emergency use of the Russian COVID-19 vaccine 'Sputnik V' with certain conditions, paving the way for a third vaccine to be available in the country.

The DCGI had in January permitted the emergency use authorisation for two COVID-19 vaccines Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune. HGCO19 has already demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models. The neutralising 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 the Drugs and Cosmetics (Ninth Amendment) Rules, 2019, to establish the safety of the vaccine candidate and has got regulatory clearance from the Review Committee on Genetic Manipulation (RCGM) and the office of the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), Government of India, to conduct clinical trials.

"Gennova has initiated the process to enrol healthy volunteers from the Phase I/II clinical trials" the DBT said. HCCOG19 is an indigenously developed vaccine on a mRNA platform. mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. They are highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, for example, eggs or bacteria. Therefore, they can be quickly manufactured inexpensively to ensure their availability and accessibility for mass vaccination on a sustainable basis.

The establishment of such a technology platform will empower India to handle the COVID-19 pandemic and ensure the preparedness for any future pandemic or endemic stage that will follow (mutation in the virus, unvaccinated low-risk population, newborns) by utilising its rapid development path. The speed of this platform technology has been already proven during the COVID-19 outbreak as mRNA candidate was the first to enter the human trials globally. Renu Swarup, Secretary, DBT, and Chairperson, BIRAC, said at the onset of COVID-19, DBT backed many vaccine development programmes, including the mRNA-based 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", Swarup said.

She said through the Mission COVID Suraksha programme, the DBT provided support also towards scale-up and clinical studies. Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd, 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. We believe the mRNA-based cutting-edge technology will play an important role in evolving effective solutions", he said.

Two more COVID-19 vaccines by Zydus Cadila, Biological E are also in the pipeline and are in advanced clinical trials in India.