Gennova, the country’s first mRNA vaccine candidate, gets the go-ahead for human trials: DBT | India News

NEW DELHI: The countryfirst indigenous mRNA vaccine candidate developed by Gennova, Pune has received approval of drug regulators to initiate phase 1/2 human clinical trials, the Department of Biotechnology he said on Friday.
The new mRNA candidate vaccine, HGCO19, is supported by an initial grant from the Ind-CEPI mission of the Department of Biotechnology.
MRNA vaccines do not use the conventional model to produce an immune response. Instead, they carry molecular instructions for making the protein in the Body through a synthetic RNA of the virus.
The host body uses this to produce the viral protein that it recognizes, causing the body to generate an immune response against the disease.
MRNA-based vaccines are scientifically the ideal choice to tackle a pandemic due to their rapid chronological development, the DBT said. It is also considered safe as it is not infectious, does not integrate by nature, and is degraded by standard cellular mechanisms.
“They are expected to be highly effective due to their inherent ability to be translated into the protein structure within the cell cytoplasm. Furthermore, mRNA vaccines are completely synthetic and do not require a host for growth, eg eggs or bacteria. .
“Therefore, they can be rapidly manufactured economically under cGMP conditions to ensure their availability and accessibility for mass vaccination in a sustainable manner,” added the DBT.
Gennova has completed all the preliminary work and should start the phase 1/2 human clinical trial soon, as approval has been received from the DCGI office, the DBT said.
“The establishment of such an indigenous technology platform will not only allow India to handle the Covid-19 pandemic, but will also ensure preparedness for future outbreaks,” said Renu Swarup, secretary of the Department of Biotechnology.
Five vaccine candidates are in different phases of clinical trials in India, and the Serum Institute of India is conducting the phase 3 trial of the Oxford-Astrazeneca Covid-19 vaccine. The vaccine developed locally by Bharat Biotech in collaboration with the ICMR has already started the phase 3 clinical trial.
Another locally developed vaccine by Zydus Cadila has also completed phase 2 clinical trials in the country.
The laboratories of Dr. Reddy and the Russian Direct Investment Fund (RDIF) have also announced the start of adaptive phase 2 and 3 clinical trials for the Covid-19 Sputnik V vaccine in India.
In addition, Biological E Ltd has begun the first phases 1 and 2 of human trials of its Covid-19 vaccine candidate.
Gennova, in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop an mRNA vaccine candidate.
HGCO19 has already demonstrated safety, immunogenicity, and neutralizing antibody activity in animals. The vaccine’s neutralizing antibody response in mice and non-human primates was comparable to sera from convalescent Covid-19 patients, the DBT said.
Gennova’s candidate vaccine uses the most prominent spike protein mutant (D614G) and also uses the self-amplified mRNA platform, which provides the advantage of a low-dose regimen compared to non-replicating mRNA or traditional vaccines.
HGCO19 uses adsorption chemistry to make the mRNA adhere to the surface of the nano-lipid carrier to improve the release kinetics of the mRNA within cells compared to encapsulation chemistry.
HGCO19 is stable at 2-8 degrees Celsius for two months.
The Department of Biotechnology is implementing the IndCEPI mission ‘India Centered Epidemic Preparedness through Rapid Vaccine Development: Supporting Vaccine Development in India’, which is aligned with CEPI’s Global Initiative and aims to strengthen the development of vaccines and associated skills / technologies for epidemic diseases. potential in India.
DBT’s Ind-CEPI mission is implemented by its PSU, the Biotechnology Industry Research Assistance Council (BIRAC).

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