India Pharma Outlook Team | Friday, 06 January 2023
BioNTech SE announced a partnership with the UK government to enrol up to 10,000 patients in clinical trials for personalised cancer therapies by the end of 2030. According to BioNTech, the multi-year collaboration will focus on cancer immunotherapies based on mRNA or other drug classes, infectious disease vaccines, and investments to expand the company's footprint in the UK. According to the agreement, the parties intend to use the UK's clinical trial network, genomics, and health data assets, with the goal of enrolling the first cancer patient in the second half of 2023.
BioNTech, which collaborated with Pfizer to develop a COVID vaccine, announced the establishment of a research and development centre in Cambridge with more than 70 scientists. BioNTech plans to invest in a UK Research and Development (“R&D”) hub in Cambridge with an expected capacity of more than 70 highly skilled scientists, the first to commence R&D by the end of the first quarter 2023. In addition, the Company 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. As of today, several hundred patients have been treated with mRNA-based cancer immunotherapies as part of BioNTech’s trials for product candidates from the Company’s FixVac and iNeST1 platforms. Since its founding, BioNTech has been developing mRNA-based cancer therapies targeting a patient’s unique tumor. 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. The Company continues to evaluate various combinations of mRNA backbone and delivery technologies with the aim of identifying highly efficient candidates with a favorable safety profile. 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.
In addition to the approved COVID-19 vaccine, BioNTech’s infectious diseases vaccine pipeline includes influenza and shingles vaccine programs, which are also partnered with Pfizer, as well as a fully owned malaria vaccine program and a herpes-simplex-virus-2 vaccine program. In total, the Company is running research and preclinical development programs targeting more than 10 additional infectious diseases.