Gennova to submit Phase-I trials data of its Covid-19 vaccine by end of July

In a significant development, Emcure Pharmaceuticals’ subsidiary Gennova Biopharmaceuticals Ltd is set to submit the data of Phase I trials for its mRNA vaccine candidate.

This would be the first mRNA Covid-19 vaccine in India.

Gennova developed the vaccine, HGCO19, in collaboration with researchers from HDT Biotech Corporation, Seattle, USA.

“We are working on it for a few months….in the next step, we will get permission for combined Phase II and III trials…and then apply for Emergency Use Authorisation,” Vikas Thapar, President, Corporate Development & Strategy, Emcure Pharmaceuticals, told DH on Monday.

Asked about the schedule, Thapar said: “It depends on approvals, however, at our stage a lot of work is going on…it’s a process and the key is safety and efficacy.”

According to him, Gennova is working on building up capacity, supply chain, investments and distribution.

Talking about the mRNA vaccine, he said unlike standard viral vaccines, which use either inactivated (or attenuated) virus or viral proteins known to cause infection, mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus.

The host body uses this to produce the viral protein recognised by the immune system, thereby making the body ready to fight against the disease.

According to him, HGCO19 is stable at 2-8°C making logistics easier.

Gennova uses the most prominent mutant of spike protein (D614G) for its vaccine candidate.

HGCO19 has lower dosing requirements as it uses the self-amplifying mRNA platform which gives it an advantage over non-replicating mRNA or traditional vaccines.

“mRNA-based vaccines have a rapid developmental timeline compared to novel vaccine development using traditional platforms,” Thapar said.