Thursday, 28 October 2021

Homegrown Gennova COVID-19 vaccine gets DCGI nod to run Phase 2,3 trials

Homegrown Gennova COVID-19 vaccine gets DCGI nod to run Phase 2,3 trials

Gennova Bio-pharmaceuticals, the Pune-based biotechnology firm developing India's first COVID-19 vaccine based on mRNA -HGCO19, on 24 August, received approval from (DCGI) the Drug Controller General of India to run Phase 2 and Phase 3 clinical test out.

Gennova submitted the Phase II and Phase III study titled 'A Prospective, Multicentre, Randomised, Active-controlled,

Observer-blind, Phase II study followed by a Phase III study to Evaluate the Safety, Tolerability,

Immunogenicity of candidate HGCO19 (COVID-19 vaccine) in healthy subjects, which the office approved from the DCGI department.

The study will be running in India at approximately 10-15 sites in Phase II and 22-27 locations in Phase III. Gennova plans to use DBT-ICMR clinical test network sites for this study.

The company submitted the interim clinical details of the Phase I study to the (CDSCO) Central Drugs Standard Control Organisation, the Government of India's National Regulatory Authority (NRA).

Homegrown Gennova COVID 19 vaccine gets DCGI nod to run Phase 2 3 trials 1unsplash image

Read More: Johnson & Johnson single dose Covid vaccine approved in India

The vaccine Subject Expert Committee (SEC) of CDSCO reviewed the interim Phase I details and found that HGCO19 was immunogenic, tolerable, and safe in the study participants.

Gennova's mRNA-based COVID-19 vaccine development program was partially funded by the Department of Biotechnology (DBT), under Ind CEPI, way back in 2020 June.

Later, the DBT further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.

"It's a matter of great pleasure for the Nation's first mRNA-based vaccine is founding to be safe and Drugs Controller General of India.

DCG(I) has approved Phase II/III trial," said Renu Swarup, Secretary, DBT and Chairperson, BIRAC.

Sanjay Singh, CEO of Genova Biopharmaceuticals Ltd., said:

"After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in Phase I clinical trial, Gennova's focus is to start Phase II/III pivotal clinical trial. In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the Nation's vaccine requirement."

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