Speaking at the 76th session of the UN General Assembly last month, Prime Minister Narendra Modi said: “India has developed the world’s first DNA vaccine. An m-RNA vaccine is in the final stages of development.”
The announcement in the lofty halls of the UNGA in New York refers to a 15-year-old Pune-based pharmaceutical company, Gennova Biopharmaceuticals, the biotech subsidiary of the Rs 6,056-crore Emcure Group, which is developing the country’s first indigenous mRNA Covid-19 vaccine, HGCO19, that is now under advanced human trials.
The firm now aims to leverage this platform for developing vaccines for Zika, Zoster and even TB. New-generation vaccines for Sars-CoV-2 are on the anvil, too – the company is working on different strains of the virus (like the variants of concern). It has administered at least the first dose to volunteers in its phase 2 trials. Phase 3 trials will be held soon in 22-27 sites across India.
Where Gennova scores is that it has achieved to crack the stringent sub-zero temperature requirements.
Unlike its global peers, its product, HGCO19, will be a lyophilized vaccine that can remain stable at 2 to 8 degrees Celsius. This would be a major advantage when it comes to distributing the vaccine within India as well as sub-Saharan Africa and other low- and medium-income countries. A lyophilized vaccine is based on freeze-drying and will come in powder form and be mixed with diluents before administration. US major Pfizer has started phase 3 clinical trials on a lyophilized version of its mRNA vaccine, and expects results this year.
Gennova’s tryst with a Covid-19 vaccine based on an mRNA platform began last February but it has been working on the platform for the past three years.
As Samit Mehta, president and chief operating officer, Gennova, recollected: “We started off with biosimilars like erythropoietin (a hormone made by the kidneys and liver). We were importing the finished products and just marketing it. Then we brought in Dr Sanjay Singh who was a tenured scientist at the National Institute of Health (NIH), US where he was heading the antigen research section.”
Samit Mehta, who is the son of Emcure group founder Satish Mehta, said that after Singh joined the group, the biotech started to focus on establishing entire value chains from start to finish.
“Singh did not just focus on products, but on creating entire product technologies. That’s how we launched tenecteplase (used in cardiac events), the world’s first biosimilar for Boehringer Ingelheim’s Metalyse,” he added.
Gradually, Gennova added different technology platforms for biologic products to its repertoire – mammalian cell line tech, E-Coli or microbial tech, yeast-based platforms and so on. One thing led to the other and Gennova inaugurated its vaccine formulation plant in 2010.
In 2019, Gennova collaborated with well-known microbiologist and immunologist Steve Reed, who was at that time setting up his own company, HDT Bio, in Seattle. This is when Gennova started working on the mRNA platform.
“The original idea was to develop a personalised therapeutic vaccine for cancer, initially for HPV (human papillomavirus) and cervical cancer. This involves getting the gene sequence from the patient, and then within 45-60 days turning it into a personalised therapeutic vaccine,” Mehta said. Gennova eventually wanted to move on to other cancers. (A therapeutic vaccine is one which is administered after a disease or infection has already occurred and works by activating the immune system of a patient to fight an infection.)
When the gene sequence of the Sars-CoV-2 was released in February last year, Gennova’s leadership thought it was time to try their hands at developing a Covid-19 vaccine using mRNA technology.
The question, of course, is how Gennova’s vaccine will fare against the competition. For one, Gennova is conducting phase 2 and 3 trials only now, so it will be some time before it hits the market. Meanwhile, Hyderabad-based Biological E has partnered with Canadian firm Providence Therapeutics for its mRNA Covid-19 vaccine and aims to make 600 million doses in 2022. US majors Pfizer and Moderna are waiting in the wings to enter the Indian market. Serum Institute of India and Biocon have recently said they are collaborating for working on this tech platform.
Emcure Group promoter and CEO Satish Mehta is optimistic. The latest research says there would be a need for booster doses of Covid-19 vaccines and he sees an opportunity here. “The best available vaccine would have demand,” he said.
There are, however, entry barriers. As Samit Mehta explains: “There are few global suppliers for enzymes and speciality chemicals that go into making the mRNA vaccines. No one had anticipated such huge demand, and big pharma players have either bought these small firms or have long-term contracts with them. So the supply chain is a challenge.”
As many as 43 different raw materials are required in the manufacturing process and Gennova and Emcure Group are working on backward integration for some of these products.
Mehta senior feels that having succeeded in making a 2-8-degree product, Gennova has a game-changer. “Emerging markets would not opt for a sub-zero cold chain product. We would see demand there. Moreover, there would be demand for booster doses that people will eventually take in the long run,” he said.
The founder of Emcure Group says that when he started his journey into branded generic drugs from a contract manufacturing company in the mid-1990s everyone had advised him against it. “We had a turnover of Rs 2-3 crore annually then, and all my friends had advised me against entering a fragmented pharma market,” he recalled.
Emcure now ranks 12th in the domestic pharma market. The real growth is expected from Gennova. As he said, “The exponential growth will come from cutting-edge technology that Gennova is working on. The mRNA platform opens up lots of opportunities for us – it’s a fourth generation technology – and we are excited about our early entry advantage.” Business Standard