MOU set to drive personalised mRNA Cancer Immunotherapies Development

The UK Government has signed an MOU with BioNTech (Mainz, Germany) to provide up to 10,000 patients with personalised mRNA cancer immunotherapies by 2030, either in clinical trials or as authorised treatments. This objective is part of a multi-year collaboration focused on three strategic pillars: cancer immunotherapies based on mRNA or other drug classes, infectious disease vaccines and investments into expanding the company’s footprint in the UK as one of its key markets.

"The parties plan to utilise the UK’s clinical trial network, genomics and health data assets with the next steps being the selection of candidates, trial sites and the set-up of a development plan with the aim of being ready to enroll the first cancer patient in the second half of 2023. BioNTech intends to design and roll out randomised trials in adjuvant or metastatic settings with registrational potential for its personalised mRNA cancer immunotherapies in the UK.

“The UK successfully delivered COVID-19 vaccines so quickly because the National Health Service, academia, the regulator and the private sector worked together in an exemplary way. This agreement is a result of the lessons learnt from the COVID-19 pandemic as we all experience that drug development can be accelerated without cutting corners if everyone works seamlessly together towards the same goal.

Today’s agreement (Jan 5) shows that we are committed to do the same for cancer patients,” said Professor Ugur Sahin, MD, Chief Executive Officer and Co-Founder of BioNTech. “Our goal is to accelerate the development of immunotherapies and vaccines using technologies we have been researching for over 20 years. The collaboration will cover various cancer types and infectious diseases affecting collectively hundreds of millions of people worldwide. If successful, this collaboration has the potential to improve outcomes for patients and provide early access to our suite of cancer immunotherapies as well as to innovative vaccines against infectious diseases – in the UK and worldwide.”

BioNTech plans to invest in a UK Research and Development hub in Cambridge with an expected capacity of more than 70 highly skilled scientists, with the first cohort commencing work by the end of the first quarter this year. There will also be a regional headquarters in London for employees in global and regional supporting functions such as regulatory, medical, IP and legal services. The company will remain the local sponsor of current and upcoming new clinical trials of its programs in the UK and will design the clinical trial protocols.

In collaboration with Pfizer, BioNTech developed the first COVID-19 vaccine which was approved in the UK, the United States and the European Union, making it the first-in-class mRNA drug product in the history of medicine. The company’s  infectious disease vaccine pipeline includes influenza and shingles vaccine programs in partnership with Pfizer; a fully owned malaria vaccine program and a herpes-simplex-virus-2 vaccine program.

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