GENNOVA’S MRNA VAX GETS NOD FOR PHASE 2 & 3 TRIALS

Indigenous MRNA Covid-19 vaccine candidate — Gennova Biopharmaceuticals’ HGCO19 — on Tuesday got the Drugs Controller General of India (DCGI) approval to start phase 2 and 3 clinical trials.

If things go according to plan, the vaccine would be available in the market before the end of this year, sources said. The Pune-based biotech company submitted interim clinical data of the phase 1 study to the Central Drugs Standard Control Organisation.

The Vaccine Subject Expert Committee reviewed the interim data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study, a statement by the Ministry of Science & Technology said.

A multicentre, randomised, active controlled, observer blind phase 2 study followed by a phase 3 study to evaluate the safety, tolerability and immunogenicity of the candidate HGCO19 is planned.

“The study will be conducted in India at approximately 10-15 sites in Phase II and 2227 sites in Phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study,” the ministry statement said.

The messenger RNA vaccine candidate contains a short, synthetic version encoding the spike protein (antigen) of the novel coronavirus Sars-cov-2. This interacts with the receptors of host cells. When the vaccine is injected into the body, the synthetic

MRNA is taken to muscle cells where it instructs the cells to make numerous copies of MRNA and copies of the antigen. This primes the body’s immune system which learns to identify the coronavirus and protect the body when it is attacked by the actual virus.

Gennova's mrna-based

vaccine development programme was partly funded by the Department of Biotechnology (DBT) in June 2020. Later on, the DBT further supported the programme under the Mission COVID Suraksha — The Indian COVID -19 Vaccine Development Mission, implemented by BIRAC.