A lung cancer patient at UCLH is the first to receive a novel
cancer vaccine designed to prime the immune system to recognise
and fight cancer cells.
It is the first time this immunotherapy made by BioNTech, the
German biotechnology company, will be studied in a clinical trial
for lung cancer in the UK, where the NIHR UCLH Clinical Research
Facility is the lead research site.
The investigational mRNA cancer immunotherapy for non-small cell
lung cancer (NSCLC) – known as BNT116 – utilises a messenger RNA
(mRNA) to present common tumour markers from NSCLC to the
patient's immune system, with the aim of helping the immune
system recognise and fight cancer cells expressing these markers.
The investigational vaccine is designed to specifically enhance
immune responses against targets primarily expressed by cancer
cells, reducing the risk of toxicity to healthy, non-cancerous
cells – unlike chemotherapy, which often affects both cancerous
and healthy cells.
UCLH consultant medical oncologist Siow Ming Lee, who leads the
national study said: “Lung cancer remains the leading cause of
cancer deaths worldwide, with an estimated 1.8 million deaths in
2020.
“We are now entering this very exciting new era of mRNA-based
immunotherapy clinical trials to investigate the treatment of
lung cancer, thanks to the foundation laid by the Office for Life
Sciences, within the Department for Science, Innovation and
Technology and the Department for Health and Social Care.
“We hope this will provide an opportunity to further improve
outcomes for our NSCLC patients, whether in the early or advanced
stages,” said Prof Lee, who is also Professor of Medical Oncology
at UCL. Prof Lee's research is supported by the National
Institute for Health and Care Research (NIHR) Biomedical Research
Centre at UCLH.
The primary objective of this study is to determine if
BNT116 is safe and well tolerated. The trial will be enrolling
patients at different stages of NSCLC, from early-stage NSCLC
before surgery or radiotherapy (Stage 2 and 3) to late-stage
disease (Stage 4) or recurrent cancer.
The trial aims to establish the safety profile and a safe dose of
BNT116 monotherapy, as well as of BNT116 in combination with
established treatments for NSCLC to see if BNT116 has a
synergistic anti-tumour effect when given with these established
chemotherapy or immunotherapy treatments.
Approximately 130 participants will be enrolled in the study
across 34 research sites in seven countries, with six UK sites
selected.
UCLH consultant medical oncologist Dr Sarah Benafif is leading
the delivery of the study at UCLH.
Dr Benafif said: “The strength of the approach we are taking is
that the treatment is aimed at being highly targeted towards
cancer cells. In this way we hope that in time we are able to
show that the treatment is effective against lung cancer whilst
leaving other tissues untouched.”
Janusz Racz, 67, from London, is the first participant in the
trial. He said: “… Dr Sarah (Benafif) explained how the
vaccine should work and how it was different to the treatment I
had recently completed. The hope was that it would stop the
cancer coming back.
“I thought it over, and … decided to take part because I hope it
will provide a defence against cancer cells. But I also thought
that my participation in this research could help other people in
future and help this therapy become more widely available.
“As a scientist myself, I know that science can only advance if
people agree to participate in programmes like this. I work in
artificial intelligence, and I am open to trying new things. My
family did research about the trial too, and they supported me
taking part.”
Professor Karl Peggs, UCLH Director of Research and Director of
the NIHR UCLH Biomedical Research Centre, said: “Developing new
approaches to treating cancer is a major priority for research at
UCLH and within the BRC, and it's exciting to see this
first-in-human research get started at UCLH.
“We are able to do this kind of research thanks to our first-rate
clinicians and research teams, our track record of working
alongside industry, and our facilities and infrastructure which
receive crucial support from the NIHR.”
Science Minister said: “It is good to see
this vaccine taking its next important step. This approach has
the potential to save the lives of thousands diagnosed with lung
cancer every year.
"With Government support, these trials demonstrate again that the
UK's world-leading life sciences sector is at the forefront of
turning research into new treatments like cancer vaccines, which
could be transformative for patients up and down the country. We
back our researchers so that they continue to be an integral part
of projects that produce groundbreaking therapies, like this
one.”
-ends-
Note to editors
Other hospital sites participating in this clinical trial are:
- Cambridge University Hospitals NHS Foundation Trust
- Velindre University NHS Trust
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Guy's and St Thomas' NHS Foundation Trust
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust