Gennova Biopharma's mRNA-based Covid-19 vaccine enters clinical trial phase
14 April 2021
Gennova Biopharmaceuticals Ltd's novel mRNA-based Covid-19 vaccine candidate `HGCO19’ being developed under `Mission Covid Suraksha’, implemented by Biotechnology Industry Research Assistance Council (BIRAC), has moved into clinical trials, says a DBT release.
DBT, which functions under the ministry of science and technology, has also 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 Ltd.
This funding has been awarded under the 'Mission Covid Suraksha, being implemented by DBT's dedicated mission implementation unit at Biotechnology Industry Research Assistance Council (BIRAC).
The programme is being implemented 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 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, 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 received regulatory clearance from the Review Committee on Genetic Manipulation (RCGM) and office of the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), 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 cGMP conditions 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,etc) by utilising 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 human trails globally.
"At the onset of Covid-19, DBT backed many vaccine development programmes, 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," Dr Renu Swarup, secretary, DBT, and chairperson, BIRAC, said,
“DBT is committed to fostering technological innovation in biotechnology in India .Through the Mission COVID Suraksha program provided support also towards scale-up and clinical studies. I wish Gennova grand success as this technology can address the mutant forms of the virus," she added.
Speaking on the development, 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."