Gennova gets DCGI nod to start Phase II/IIII trials for its mRNA vaccine

Gennova Biopharmaceuticals on Tuesday received approval from the Drugs Controller General of India (DCGI) to start Phase II/III trials for its Covid-19 vaccine. Gennova has developed the HGCO19 Covid-19 vaccine, which is the country’s first mRNA-based vaccine. The company has committed to making 60 million doses by the year-end.

The company submitted the interim clinical data of the Phase I study to the regulatory authority, Central Drugs Standard Control Organisation (CDSCO). The Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data and found that HGCO19 was safe, tolerable and immunogenic.

Genova is a biotechnology focused company of the Pune-based pharma company, Emcure Pharmaceuticals. Gennova developed the vaccine in partnership with the support of the Department of Biotechnology (DBT) under the ministry of science & technology and its PSU, Biotechnology Industry Research Assistance Council (BIRAC). The mRNA platform is a new technology and global pharma companies like Pfizer and Moderna have administered millions with the mRNA Covid-19 vaccine over the last year.

Sanjay Singh, CEO of Gennova Biopharmaceuticals, said after establishing the safety of the mRNA-based Covid-19 vaccine candidate HGCO19 in Phase I clinical trial, the company would start Phase II/III clinical trial. “In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation’s vaccine requirement,” Singh said.

Gennova submitted the proposed Phase II and Phase III study for a multicentre, randomized, observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the safety, tolerability and immunogenicity of the HGCO19 Covid-19 vaccine candidate in healthy subjects. The study will be conducted in India at 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.

Renu Swarup, secretary, DBT and chairperson, BIRAC said this was an important milestone in the indigenous vaccine development mission and positioned India on the global map for novel vaccine development.

According to Emcure’s top management, Gennova would benefit from the fill and finish facilities available at its parent company. Emcure has a lot of injectibles capacity, which could be reconfigured. The company was planning to repurpose a major portion of some of its existing facilities towards ramping up vaccine production. Down the line, there were also plans of partnering with contract manufacturing organizations in India. The company was confident of delivering 60 million doses by year-end.