Gennova starts enrolment for Phase I/II human trials for its mRNA vaccine

NEW DELHI: India's mRNA-based covid-19 vaccine candidate-HGCO19, developed by Pune-based biotechnology company Gennova Biopharmaceuticals Ltd has received additional government funding for its clinical studies.

The department of biotechnology (DBT), ministry of science & technology on Tuesday announced approval of additional funding awarded under 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)'.

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DBT has been hand-holding Gennova 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 Corp., US, has developed the covid-19 mRNA vaccine—HGCO19.

HGCO19 has already demonstrated safety, immunogenicity, neutralization antibody activity in 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 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. Gennova has initiated the process to enroll healthy volunteers from the Phase I/II 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. Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, eg, eggs or bacteria. Therefore, they can be quickly manufactured inexpensively under Current Good Manufacturing Practice (cGMP) conditions to ensure their 'availability' and 'accessibility' for mass vaccination on a sustainable basis.

“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,” Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd said.

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, etc.) by utilizing its rapid development path. 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, the government said.

"At the onset of covid-19, DBT backed many vaccines 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,” Dr Renu Swarup, secretary, DBT, and chairperson, BIRAC, said.