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New Delhi: India’s first mRNA-based COVID-19 vaccine candidate HGCO19 has been approved for Phase 2/3 clinical trials by Genoa Biopharmaceuticals Ltd, the Department of Biotechnology (DBT) said on Tuesday.
The Pune-based biotechnology company had submitted interim clinical data from a phase 1 study of the vaccine to the Central Drugs Standard Control Organization (CDSCO).
The Vaccine Subject Expert Committee (SEC) reviewed interim Phase 1 data and found that the HGCO19 vaccine was safe, tolerable, and immunogenic in study participants.
Genova submitted a proposed Phase 2 and Phase 3 study titled ‘A Prospective, Multicenter, Randomized, Active-Controlled, Observer-Blind, Phase 2 Study’, followed by a Phase 3 study of candidate safety, tolerability and immunogenicity. To evaluate HGCO19 (COVID-19 Vaccine) in healthy subjects which was approved by the office of DCG (I), CDSCO,” the DBT said.
The study will be conducted at around 10-15 sites in Phase 2 and 22-27 sites in Phase 3 in the country. Genoa plans to use the DBT-ICMR clinical trial network sites for this study, it said.
Genova’s mRNA-based COVID-19 vaccine development program was partially funded by DBT under Ind CEPI in June 2020.
Later, DBT supported the program under ‘Mission COVID Suraksha The Indian COVID-19 Vaccine Development Mission’ implemented by BIRAC.
Renu Swarup, Secretary, DBT and Chairperson of the Biotechnology Industrial Research Assistance Council (BIRAC), said this is an important milestone in the country’s indigenous vaccine development mission, and it puts India on the global map for novel vaccine development.
Sanjay Singh, CEO, Genova Biopharmaceuticals Ltd., said, “After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in a Phase 1 clinical trial, Genova focused on starting the Phase 2/3 pivotal clinical trial. To do.
“In parallel, Genoa is investing in scaling up its manufacturing capacity to meet the country’s vaccine requirement,” he said.
read also: Third wave could be worse than 2 if not vaccinated, bring to 6L cases/day, warns government
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