Providence will sell up to 30 mn doses of its mRNA vaccine to Biological E. It would also provide the necessary technology transfer to make the vaccine in India, with a minimum production capacity of 600 mn doses in 2022 and targets capacity of 1 bn doses, reports Sohini Das.
Hyderabad-based Biological E tied up with Calgary-based Providence Therapeutics to manufacture its mRNA technology-based Covid-19 vaccine and do clinical trials in India. The deal assumes significance as this gives India access to the mRNA technology.
The vaccine, named PTX-COVID19-B, is under development in Canada at the moment. Providence announced data from the phase 1 trials in May and will begin the phase 2 trials soon.
“The mRNA platform has emerged as the front runner in delivering the first vaccines for emergency use to combat the COVID-19 pandemic. Biological E. is very pleased to be able to work with Providence on its promising mRNA vaccine candidate. We hope to provide India and other countries yet another option to ramp up their efforts towards achieving herd immunity against COVID-19,” said Mahima Datla, Managing Director of Biological E Limited.
While the financial terms of the deal were not disclosed, Providence will sell up to 30 mn doses of its mRNA vaccine to Biological E. It would also provide the necessary technology transfer to make the vaccine in India, with a minimum production capacity of 600 mn doses in 2022 and targets capacity of 1 bn doses.
“Biological E will be responsible for all clinical development and regulatory activities for the mRNA vaccine in India and other jurisdictions licensed by Biological E,” the company said.
“This initiative is an important commitment by a Canada-based company to help India and other nations vaccinate their citizens against COVID19. Providence was founded to serve patients, and this commitment by Biological E allows us to achieve that essential goal,” indicated Brad Sorenson, CEO of Providence.
Biological E already has a deal in place to make over 500 mn doses of the single dose Johnson and Johnson (J&J) vaccine. J&J’s is a viral vector based vaccine which uses human adenovirus Ad26.
India already has one mRNA vaccine in development by Pune-based Gennova Biopharmaceuticals which is in phase 1 clinical trials.
In a May 12 press statement, Providence has said that its phase 1 studies on 60 subjects have shown PTX-COVID19-B to be generally safe and well tolerated. It exhibited "strong virus neutralisation". It already has an agreement in place to supply 2 mn doses of PTX-COVID19-B to the government of Manitoba in Canada.
According to media reports, Providence was planning to move the clinical trials out of Canada.
Apart from the J&J and Providence Covid-19 vaccine deals, Biological E also has under development a third candidate with Baylor College of Medicine. The Baylor College of Medicine-Biological E vaccine is set to begin phase 3 clinical trials in June. This is a protein sub-unit technology based vaccine, a technology that Biological E already had. This technology is used to make Hepatitis B vaccines.
The Indian government has indicated that in the second half of the year, it expects to receive 300 mn doses of the Biological E vaccine.
India is already in talks with US players Pfizer and Moderna for bringing their USFDA-approved mRNA Covid-19 vaccines to India. Canada is using both Pfizer and Moderna vaccines to inoculate its citizens.