Update (29/04/2020): A vaccine developed by the German company BioNTech and its big pharma partner Pfizer has become the first European mRNA vaccine for Covid-19 to enter human testing in a phase I/II trial.
Since dosing began last week, twelve volunteers in Germany have been given the vaccine. The first part of the trial — the dose-escalation protocol — is expected to test the safety and effectiveness of different forms and doses of the vaccine in just under 200 people.
This announcement swiftly follows the first human dosing last week of a Covid-19 viral vector vaccine developed by the University of Oxford. BioNTech and Pfizer also plan to start clinical trials for the same vaccine in the US as soon as they receive regulatory approval. In addition, BioNTech expects to carry out clinical trials in China with its partner, Fosun Pharma.
Update (14/04/2020): BioNTech and Pfizer have shed more light on their collaboration to develop an mRNA vaccine for coronavirus disease, with BioNTech due to receive €170M upfront and up to €519M in milestone payments.
The €170M upfront payment to BioNTech includes €66M in cash and an equity investment of around €104M. Pfizer will initially pay the full developmental costs of the vaccine, but BioNTech will reimburse Pfizer for 50% of the costs during the commercialization stage.
The two partners plan to begin phase I testing of multiple mRNA vaccine candidates for Covid-19 this month. If the development goes to plan, they then aim to scale up the vaccine production to hundreds of millions of doses in 2021.
Update (17/03/2020): BioNTech has announced it has agreed to co-develop and distribute its mRNA Covid-19 vaccine candidate with Pfizer outside of China.
This agreement adds to the existing 2018 partnership between the two companies to produce an mRNA-based flu vaccine.
BioNTech has jumped to the front of the queue of European companies trying to get a vaccine for the coronavirus to market with an announcement of clinical testing at the end of next month and a big Chinese investment.
The German biotech has partnered with Shanghai-based Fosun Pharma to develop the vaccine for coronavirus disease ‘Covid-19’ in a deal worth up to €120M in combined upfront and milestone payments. As an initial payment, Fosun has agreed to pay €44M for 1.5M ordinary shares of equity in BioNTech.
If the vaccine is successfully approved, the deal is potentially very lucrative for the two companies. Fosun will hold the rights to commercialize the vaccine in China, if it gets regulatory approval, and BioNTech will hold the rights for the rest of the world. BioNTech will also share any profits from sales in China with Fosun.
BioNTech’s primary focus is cancer, but the company also has infectious disease programs in development. It has used its expertise with RNA and vaccines to rapidly develop a prophylactic, first-in-class mRNA vaccine candidate against Covid-19. mRNA vaccines can be highly targeted and provoke a strong immune response. They can also be developed within a few months, which has huge benefits when trying to tackle a pandemic such as Covid-19.
“Our core competence includes a depth of understanding of the immune system and we feel we have a duty to fully exploit our technology and immunotherapy expertise to help address the Covid-19 pandemic emergency,” Sean Marett, Chief Business and Commercial Officer at BioNTech, told me.
“It may take many different strategies and approaches to find a suitable and effective vaccine… We don’t see this as a competitive race but rather as a global effort to quickly battle an epidemic and save lives.”
The vaccine candidate will be trialed in humans at the end of April, starting in Germany and expanding to China and the USA. The two companies will work together to develop the vaccine in China, with BioNTech supplying the vaccine for clinical trials from its manufacturing facilities in Europe in collaboration with its Austrian partner Polymun.
Fosun will use its clinical trials, regulatory and commercialization experience in China to help the vaccine get to market. BioNTech already has a partnership with Pfizer to develop a flu vaccine and is in discussion with the big pharma to potentially collaborate to develop the Covid-19 vaccine outside China.
“We are working closely together with regulatory agencies and our existing collaborators in the infectious disease field, including Pfizer, to rapidly initiate trials in order to make a vaccine available to the public as quickly as possible worldwide,” commented Founder and CEO of BioNTech, Ugur Sahin.
“In addition, we are working on a novel therapeutics approach for those patients who have already been infected – we plan to disclose more on that effort in the coming weeks.”
BioNTech is one of the closest to the clinic, but there are many other companies who are also hoping to get a shot at developing a successful Covid-19 vaccine. Until recently, it seemed as though the collaboration between the Oslo-based public-private funder Coalition for Epidemic Preparedness (CEPI) and the German biotech CureVac might be one of the first to market, with its own mRNA vaccine for Covid-19. However, it now seems that BioNTech may beat them to it.
BioNTech is hot on the heels of US giant Moderna, which announced it had started testing its mRNA coronavirus vaccine in humans today. Time will tell who will be first to market approval with an effective and safe vaccine, although those developing mRNA candidates do seem to be the fastest to the clinic so far.
Images via BioNTech