India's first mRNA Covid-19 vaccine moves to advanced clinical trials

India’s vaccine development efforts have got a further fillip with the first mRNA-based Covid-19 vaccine candidate HGCO19, being developed by Pune-based Emcure Pharmaceuticals' subsidiary Gennova Biopharmaceuticals, entering into the next stage of clinical trials.

A few days ago, India had approved the world's first plasmid DNA vaccine, ZycoV-D from Zydus Cadila. The Drug Controller General of India yesterday approved Phase II and Phase III study protocols for HGCO19, following the Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data, and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study. The next stage trial is to commence in early September.

The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study. mRNA-based vaccines got global focus following the huge success of Pfizer BioNTech and Fosun Pharma's Covid-19 vaccine Comirnaty (BNT162b2) and US-based Moderna's Covid-19 vaccine mRNA-1273. It was the first time mRNA platform-based vaccines were developed for human use. Both these vaccines  have become a huge commercial success for Pfizer and Moderna.

mRNA vaccines present various benefits as they are non-infectious, non-integrating in nature, and degraded by normal cellular mechanisms. These are highly efficacious because of their inherent capability to be translatable into the cell cytoplasm's protein structure and are developed at a rate faster than traditional vaccines under the cGMP conditions.

At present, globally, other companies are also developing mRNA-based Covid-19 vaccines. Prime among them are GlaxoSmithKline and CureVac's CVnCoV, which is now in Phase 2b/3 advanced trials. In China, Walvax Biotechnology-Abogen Biosciences and Yuxi Walvax Biotechnology combine are developing ARCoV, which is now in the Phase 3 stage of final trials. Japanese company Daiichi Sankyo is developing a mRNA-based vaccine DS-5670a, which is now in Phase 1/2 stage.

French drug major Sanofi and Translate Bio is developing a mRNA-based vaccine MRT5500, which is also in the Phase 1/2 stage. Canada's Providence Therapeutics' PTX-COVID19-B and an unnamed vaccine candidate from Stemirna Therapeutics and Shanghai Municipal Science and Technology Commission are also in first phase of clinical studies.

“The approval for Phase II and III protocol for what could be country’s first mRNA platform-based COVID-19 vaccine brings us immense satisfaction and highlights the grit of scientists unified for a common cause. The global pandemic has brought into the foray R&D that is safe, reliable, accessible and quickly available. HGCO19 was developed keeping the same objectives in mind and using the exciting possibilities of mRNA technology," says Dr. Sanjay Singh, CEO-Gennova Biopharmaceuticals.

Gennova's mRNA-based COVID-19 vaccine development program was partly funded by the Department of Biotechnology (DBT), Government of India under Ind-CEPI, way back in June 2020. Later on, the DBT further supported the program under the Mission COVID Suraksha - The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.

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