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Nation’s first mRNA vaccine gets approval for Phase II/III trials

Gennova Biopharmaceuticals Ltd., the Pune-based biotechnology company submits interim clinical data of the Phase I study. Vaccine subject expert committee (SEC) reviewed Phase I data and found that the vaccine ewas safe, tolerable, and immunogenic in the participants of the study.

Gennova Biopharmaceuticals Ltd., the Pune-based biotechnology company, which has developed India’s first mRNA-based COVID-19 vaccine, submitted the proposed Phase II and Phase III study entitled ‘A prospective, multicentre, randomized, active-controlled, observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the safety, tolerability, and immunogenicity of COVID-19 vaccine in healthy subjects”. The phase II and III trials have been approved by the office of the Drugs Controller General of India DCG(I) (DCG(I)), CDSCO.

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.

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

Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC said that “It is a matter of great pride that Nation’s first mRNA-based vaccine is found to be safe and the DCG(I) has approved Phase II/III trial. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our indigenous vaccine development mission and positions India on the global map for novel vaccine development.”

Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd., said that “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.

About BIRAC

A non-for-profit Public Sector Enterprise, Biotechnology Industry Research Assistance Council (BIRAC), has been set up by the Department of Biotechnology (DBT), Government of India, which acts as an interface agency to enhance and encourage the evolving biotechnology industry to implement strategic research and development activities in regards to the product development needs of the Nation.

About Gennova

Gennova Biopharmaceuticals Ltd., an Emcure group of companies, is headquartered in Pune, India. Gennova is a biotechnology company dedicated to biotherapeutics’ research, development, production, and commercialization to address life-threatening diseases across various indications.

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