Clinical trials on India's first mRNA Covid-19 vaccine to begin soon

Emcure Group firm Gennova Biopharmaceuticals, which is developing India’s first mRNA-based Covid-19 vaccine, is set to start recruitment for phase 1 clinical trials in a week.
 
Vikas Thapar, president — corporate development & strategy — Emcure Group, told Business Standard that the firm was readying for clinical trials anytime now. “We got the final nod from the regulator last week to start phase 1 clinical trials. We are going to start it anytime now. The recruitment will begin next week. Phase 1 would be on about 150 people,” Thapar said.
 
As for manufacturing, he said Emcure had sterile products manufacturing capacity. “We are tweaking part of this capacity to make the mRNA vaccine. We are also open to fill and finish opportunities with partners outside Emcure,” he said.

 

In December, the firm had approached drug regulator Drugs Controller General of India (DCGI) with details of the pre-clinical (or animal) toxicology studies.
 
“Some of these studies were done overseas. We were asked to conduct the studies in India also as this is a completely new technology platform for vaccines in India. We did that and again approached the regulator. We have now secured nod to start phase 1 clinical trials,” Thapar added.
 
He added Gennova was working on mRNA technology for oncology products. When the pandemic hit, it thought of working on a vaccine using the same technology.

 
Gennova’s Covid vaccine candidate HGCO19 would remain stable at 2 to 8 degree Celsius temperature, unlike global peers from Pfizer-BioNTech and Moderna that require sub-zero temperatures.
 
Gennova has tied up with Seattle-based HDT Biotech Corporation and also received seed funding from the department of biotechnology for developing this candidate.
 
Only recently, the firm received a funding of around Rs 70 crore from the department of biotechnology for its vaccine candidate.
 
The firm has a planned capex of Rs 250 crore for facility expansion and is funding it through Rs 135-crore debt. The remaining will be through a government grant.

 
How does HGCO19 work?
 
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. It protects the body when it is attacked by the virus.