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HGCO19 vaccine candidate: Gennova starts enrolment for Phase 1/2 human clinical trials

PTI Our Bureau New Delhi | Updated on April 13, 2021

The DBT said it has approved additional funding towards clinical studies of the country’s first of its kind’ mRNA-based Covid-19 vaccine

The Department of Biotechnology (DBT) in 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.

This vaccine has been developed by Pune-based biotechnology company Gennova Biopharmaceuticals Ltd.

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 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’, an official release said.

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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.

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.”

She also said that DBT is committed to fostering technological innovation in biotechnology in India.

Speaking on the development, CEO of Gennova Biopharmaceuticals Ltd, 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.”

Gennova has initiated the process to enrol healthy volunteers for the Phase I/II clinical trials, the release added.

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.

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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 and office of the Drugs Controller General of India, Central Drugs Standard Control Organization to conduct clinical trials.

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.

Published on April 13, 2021

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