India's mRNA COVID-19 Vaccine Candidate Nears Finish Line

India-based Gennova Biopharmaceuticals Ltd. confirmed it had been granted authorization to conduct phase 2/3 clinical trials for the mRNA-based COVID-19 vaccine candidate HGCO19.

Gennova submitted the proposed Phase II and Phase III study entitled “A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate safety and tolerability, and immunogenicity of the vaccine candidate HGCO19 in healthy subjects."

India's Department of Biotechnology (DBT) issued this authorization on August 24, 2021.

In a press release, Dr. Renu Swarup, Secretary, DBT, and Chairperson, stated, “It is a matter of great pride that Nation’s first mRNA-based vaccine is found to be safe and the Drugs Controller General of India. DCG has approved Phase II/III trial."

"We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development.”

The mRNA vaccine candidate HGCO19 contains a short, synthetic version encoding the spike protein (antigen) of the novel coronavirus, SARS-CoV-2, reported interacting with receptors on host cells. When the vaccine is injected into the body, the synthetic mRNA is taken to muscle cells, where it instructs cells to make numerous copies of mRNA and, in turn, multiple copies of the antigen.

Gennova also discloses HGCO19 uses the self-amplifying mRNA platform, which gives the clinical advantage of a low dose regimen. And HGCO19 uses the adsorption chemistry to attach the mRNA to the nano-lipid carrier’s surface to enhance the release kinetics of the mRNA within the cells compared to the encapsulation chemistry.

Gennova Biopharmaceuticals Limited is headquartered in Pune, India, and is a biotechnology company dedicated to developing, producing, and commercializing biotherapeutics to address life-threatening diseases across various indications. The company is located at T-184, MIDC, Bhosari, Pune – 411 026, Maharashtra, India.