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Pune-based firm plans clinical trial of COVID-19 vaccine by year-end, gets seed funding from Centre

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Amid extensive research on the development of a COVID-19 vaccine, the Central government has provided seed funding to an Indian company for novel mRNA based vaccine candidate for coronavirus. 

The Department of Biotechnology under the Ministry of Science & Technology has provided seed funding for the development of Gennova’s novel self-amplifying mRNA-based vaccine candidate for COVID19.

The vaccine is likely to go to clinical trial by the year-end. 

According to the ministry, Gennova has developed an mRNA vaccine candidate (HGCO19) in collaboration with HDT Biotech Corporation, Seattle, USA. The vaccine candidate has demonstrated safety, immunogenicity, neutralization 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, it said. 

The establishment of ‘first-of-its-kind’ mRNA-based vaccine manufacturing platform in India is being facilitated by the Biotechnology Industry Research Assistance Council (BIRAC). 

Speaking on the subject, Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “Diseases emanating from unknown and new pathogens require novel ideas for effective mitigation. Gennova’s mRNA platform supported by DBT utilizes 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,” the official was quoted as saying in a ministry press release. 

Speaking on the development, CEO of Gennova Biopharmaceuticals Ltd, Dr Sanjay Singh said, “Bold moves are necessary to create globally competitive and sustainable solutions. Gennova appreciates DBT- BIRAC’s initiative, guidance, and financial support towards the development of mRNA based next-generation vaccine.”

“Our partnership is poised towards creating an eco-system for cutting-edge technology, providing solution towards making a cost-effective vaccine that can reach to the masses in a pandemic situation like COVID-19,” Singh said. 

Headquartered in Pune, Gennova Biopharmaceuticals Ltd is a biotechnology company dedicated to the research, development, production, and commercialization of biotherapeutics to address life-threatening diseases across various indications.

According to the ministry, 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, above the US-FDA recommended titre of 1:160 for neutralizing antibodies.

Further, advantages of HGCO19 are its mRNA platform design and delivery vehicle. 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 bioavailability.

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