Gennova Biopharmaceuticals, the Pune-based biotechnology company which is developing India's first mRNA-based COVID-19 vaccine HGCO19, on August 24 received approval from the Drug Controller General of India (DCGI) to conduct Phase 2 and Phase 3 clinical trials.
Gennova submitted the proposed Phase II and Phase III study titled 'A Prospective, Multicentre, Randomised, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects', which was approved by the office of the DCGI.
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.
The company submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India's National Regulatory Authority (NRA).
The vaccine Subject Expert Committee (SEC) of CDSCO reviewed the interim Phase I data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study.
Gennova's mRNA-based COVID-19 vaccine development programme was partly funded by the Department of Biotechnology (DBT), under Ind CEPI, way back 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.
“It is a matter of great pride that Nation’s first mRNA-based vaccine is found to be safe and the 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 Gennova 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."