The multi-year collaboration focuses on three strategic pillars: cancer immunotherapies (based on mRNA or other drug classes), infectious disease vaccines and the establishment of a R&D hub in Cambridge and broader expansion into the UK market for the German mRNA pioneer.
The partnership will also accelerate clinical trials for personalized mRNA immunotherapies in the UK and help cancer patients gain early access to such trials.
Personalized cancer therapy development
While globally known for its COVID-19 vaccine development, BioNTech has been developing mRNA-based cancer therapies targeting a patient’s unique tumor since it was founded.
In 2012, the first mRNA-based personalized cancer therapy developed by BioNTech was administered in a first-in-human trial. The first patient to receive a fully individualized mRNA-based cancer therapy developed by BioNTech was treated in a clinical trial in 2014. In 2015, the first patient received an exploratory mRNA-based cancer treatment intravenously, with BioNTech pioneering the first intravenous nanoparticle delivery of mRNA vaccines in humans. It continues to evaluate various combinations of mRNA backbone and delivery technologies with the aim of identifying highly efficient candidates with a favorable safety profile.
So far, several hundred patients have been treated with mRNA-based cancer immunotherapies as part of BioNTech’s trials for product candidates from its FixVac and iNeST platforms.
Accelerating clinical trials and opening access for patients
As part of the MoU, BioNTech and the UK government plan to accelerate trial site and patient recruitment for clinical candidates of BioNTech’s pipeline for personalized mRNA cancer immunotherapies and infectious disease vaccines.
To achieve this, the parties plan to utilize the UK’s clinical trial network, genomics and health data assets. The next steps of the collaboration will be 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 randomized trials in adjuvant or metastatic settings with registrational potential for the its personalized mRNA cancer immunotherapies in the UK.
Access to the trials will be through the 'Cancer Vaccine Launch Pad', which is being developed by NHS England and Genomics England.
The launch pad will help to rapidly identify large numbers of cancer patients who could be eligible for the trials and explore potential vaccines across multiple types of cancer.
The partnership will aim to help patients with early- and late-stage cancers. “If successfully developed, the cancer vaccines could become part of standard care,” notes the UK government.
BioNTech plans to invest in a UK Research and Development hub in Cambridge with an expected capacity of more than 70 scientists, the first to commence R&D by the end of the first quarter 2023. In addition, BioNTech will strengthen its UK footprint by setting up a regional headquarter in London to accommodate employees in global and regional supporting functions including Regulatory, Medical, Intellectual Property and Legal.
As part of the MoU, BioNTech 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.
“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,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.
“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 shows that we are committed to do the same for cancer patients. 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.”