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Pune-based Gennova Biopharmaceuticals which received regulatory approval for clinical trials of its indigenous mRNA vaccine four months ago will start human trials this month, a top company executive said.

Drugs Controller General of India V.G. Somani allowed Gennova, a subsidiary of Pune-based Emcure Pharmaceuticals, to conduct phase 1 and 2 clinical trials in December. However, the trial got delayed after the regulator asked the firm to redo an animal toxicity study that had been conducted in the US.

“The DCGI cleared it in December, but we had originally submitted our pre-human animal toxicity studies from the work we had done in the US. mRNA is a brand-new technology and there’s no commercial mRNA product in India. There were certain protocols and formalities to be followed, wherein they wanted us to repeat the animal toxicity studies in the Indian setting," Vikas Thapar, Emcure Pharmaceuticals’ president of corporate development and strategy, said.

Gennova’s will be the first indigenously developed messenger RNA vaccine, following the success of similar vaccines by Pfizer and Moderna. Thapar expects the company to move into the second phase of the trial about two months after it starts the first phase. While the first phase focusses on safety, the second is aimed at proving the vaccine produces an immune response. The third phase of the trial is considered the most onerous as it is used to determine efficacy.

He said the company is considering seeking an emergency licence from the DCGI if it has successful phase 2 data, as was the case with Bharat Biotech International’s Covaxin in January, which would allow it to conduct the phase 3 trial in parallel with the roll-out.

“We have to deal with complexities around scaling up manufacturing, partnering and the Indian government telling us what their requirements are. I think those are all different challenges we’ll have to deal with at that point in time, as we think through this," Thapar said, adding that the company will consider partnering with companies to fill-finish vaccines.

Thapar said he does not foresee production of drug substance for the vaccine to be of immediate concern but the company will need to consider partnerships. The company is also looking at producing some of its own raw materials for its vaccine. Unlike the two US-based firms’ vaccines that require ultra-low temperature freezers for storage, Gennova’s vaccine candidate can be stored at normal refrigerator temperature of 2 to 8 degree Celsius.

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