Gennova Biopharmaceuticals, which is working on India’s first mRNA Covid-19 vaccine, is in the midst of Phase-I trials of its Covid-19 vaccine (HGC019). Vikas Thapar, president – corporate development & strategy, Emcure Pharmaceuticals, said the Phase-I trials will be completed in the next 45-60 days. Phase-II trials will resume after that and take a similar time frame, he added.
Gennova is a biotech subsidiary of Pune-based Emcure Pharmaceuticals.
Gennova started Phase-I trials last month and has covered 120 volunteers. They have reached halfway and are tracking volunteers for safety and efficacy. “Once we have much more confidence that the clinical trials are going well, we will probably start scaling up manufacturing, but it is hard to give a concrete timeline,” Thapar said.
The mRNA vaccines are showing some of the highest efficacy results that the company has seen thus far. Thapar said he was hoping the Gennova vaccine candidate would come close to meeting those expectations.
Meanwhile, the company is in project management mode in terms of resources required to run the manufacturing lines, the supply chains of key ingredients and logistics. Gennova will benefit from the fill and finish facilities available with Emcure Pharmaceuticals. “We are thinking of repurposing a major portion of some of these facilities towards ramping up vaccine production. Down the line we could look at partnering with contract manufacturing organisations in India or abroad to augment in-house manufacturing,” Thapar said.
Even though the mRNA platform is a new technology, Gennova’s learning is expected to come from global companies like Pfizer and Moderna that have inoculated millions with the mRNA vaccine in the US, Europe and other parts of the world. “We are lucky to piggyback on that about the mRNA platform as a safe concept and worked upon for a number of vaccines over decades,” Thapar said.
Gennova has been granted `115 crore by the government and this funding is based on different milestones achieved and towards clinical trials.