New Delhi: Gennova Biopharmaceuticals Ltd’s novel mRNA-based covid-19 vaccine candidate HGCO19 that uses nanotechnology is likely to enter clinical trial before the end of 2020, the government said on Friday.
Department of Biotechnology- Biotechnology Industry Research Assistance Council (DBT- BIRAC) has facilitated the establishment of the messenger RNA or mRNA-based vaccine manufacturing platform in India and provided seed funding for the vaccine candidate.
In collaboration with HDT Biotech Corporation, US, Gennova has developed the vaccine candidate that has demonstrated safety, immunogenicity, and neutralization antibody activity in rodent and non-human primate models.
The company is working to ensure a human injection by the end of the year, subject to Indian regulatory approvals, the DBT said in a statement.
“Diseases emanating from unknown and new pathogens require novel ideas for effective mitigation. Gennova’s m-RNA platform supported by DBT utilizes the advances in nucleic acid vaccine and delivery systems," said Renu Swarup, secretary, DBT and chairperson, BIRAC.
“This vaccine candidate that makes use of nanotechnology has shown promise to be effective in animal models. This vaccine candidate can be rapidly scaled up, once proven effective in human clinical trials,"’ she 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 neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of covid-19.
HGCO19 uses a ‘self-replicating mRNA platform’ that ensures the low injectable dose (dose-sparing effect) and sustained antigen release for a longer duration. ‘LION delivery system’ used for HGCO19 has adjuvanting property, enhanced storage stability, reduced adverse effects, improved permeability and bio-availability, the DBT said.
Gennova Biopharmaceuticals Ltd., headquartered in Pune, India, is a biotechnology company dedicated to the research, development, production, and commercialization of biotherapeutics to address life-threatening diseases across various indications.