The Department of Biotechnology on Friday (July 24) said it has provided seed funding for the development of Gennova’s novel self-amplifying mRNA-based vaccine candidate for COVID-19.
In collaboration with HDT Biotech Corporation, USA, Gennova has developed an mRNA vaccine candidate (HGCO19), with demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models.
The company is working aggressively to ensure first human injection by the end of the year, subject to Indian regulatory approvals.
“DBT-BIRAC has facilitated the establishment of the first-of-its-kind mRNA-based vaccine manufacturing platform in India. DBT has provided seed funding for the development of Gennova’s novel self-amplifying mRNA-based vaccine candidate for COVID-19,” the DBT said in a statement.
HGCO19 uses a self-replicating mRNA platform that ensures the low injectable dose (dose sparing effect) and sustained antigen release for a longer duration, a statement by the DBT said.
The novel mRNA vaccine candidate, HGCO19, has all the necessary arsenal to guide the host cells to make the antigen-spike protein of the virus, reported to interact with host cells receptor, and supported by lipid inorganic nanoparticle (LION) as a delivery vehicle, the statement added.
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, above the US-FDA recommended titre of 1:160 for neutralising antibodies, the statement said.
Further, advantages of HGCO19 are its mRNA platform design and delivery vehicle.
Renu Swarup, secretary of DBT and chairperson of Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the DBT, said diseases emanating from unknown and new pathogens require novel ideas for effective mitigation.
“Gennova’s m-RNA platform supported by DBT utilises the advances in nucleic acid vaccine and delivery systems. This vaccine candidate that makes use of nanotechnology has shown promise to be effective in animal models. With the kind of capacities Gennova has, I am confident that this vaccine candidate can be rapidly scaled up, once proven effective in human clinical trials,” she said.
Speaking on the development, CEO of Gennova Biopharmaceuticals Ltd Sanjay Singh said. Bold moves are necessary to create globally competitive and sustainable solutions. Gennova appreciates DBT- BIRAC initiative, guidance, and financial support towards the development of mRNA based next-generation vaccines.
The DBT is also partially funding the development of another vaccine candidate for coronavirus by Zydus Cadila which is already in the human trial stage.