Clinical trials begin for promising new cancer treatment
A new type of cancer treatment developed in Southampton is entering clinical trials for the first time.
It is hoped the new treatment will greatly improve the success rate of immunotherapy.
Gareth Thomas, Professor of Experimental Pathology at Southampton, has been working on the research for about 10 years.
He and his team are collaborating with a Swedish pharmaceutical company to deliver a new trial in Europe and the United States.
What is immunotherapy?
Immunotherapy has been the biggest breakthrough in cancer treatment in recent years. It helps the immune system recognise and attack cancer cells. However, it is only effective in about 20 per cent of patients.
Research led by the University of Southampton, supported by Cancer Research UK, has shown that a new drug could significantly improve the success rate of immunotherapy.
Professor Thomas explained: “Our research has been focused on a type of normal cell found in cancers – cancer-associated fibroblasts (CAFs). Cancers containing lots of these normal cells tend to behave aggressively and are resistant to treatment.
“We found that CAFs shield tumours from the patient’s immune system. This prevents ‘killer’ lymphocytes from penetrating the tumour to combat malignant cells. This is significant in terms of immunotherapy, which works by boosting this immune response.
“We also identified an enzyme called NOX4, which is important in the formation of CAFs. We found that inhibiting NOX4 prevented CAF formation and improved response to immunotherapy.”
Global trial
Professor Thomas and his team, through the University of Southampton, have now signed an Intellectual Property (IP) Agreement with Calliditas Therapeutics. The Swedish pharmaceutical company has developed a NOX4 inhibitor that is currently being tested to treat kidney, liver and lung fibrosis.
The clinical trial is underway at over 30 centres in Europe and the United States. It is testing the effectiveness of this NOX4 inhibitor (setanaxib) in combination with pembrolizumab, one of the most common immunotherapy drugs.
“Even though immunotherapy has produced very exciting results, most patients fail to respond,” said Professor Thomas. “The presence of CAFs is recognised as a resistance mechanism, and lots of patients have this type of cell in their cancers. This new treatment could potentially be of great benefit to many patients. It will be really exciting to see the outcomes of the clinical trial.”
Long-term collaboration
The phase 2 clinical trial is enrolling patients with recurrent or metastatic head and neck cancer. Around 80 per cent of these patients have CAF-rich tumours.
The trial will enrol approximately 50 patients. This will include Poole Hospital, The Royal Marsden Hospital, The Royal Liverpool University Hospital and St Bartholomew’s Hospital in the UK.
Dr Richard Philipson, Chief Medical Officer of Calliditas Therapeutics, said:
“We are very excited to have initiated this phase 2 clinical trial. This marks an important step in our long-term collaboration with Professor Thomas and his team at the University of Southampton.
“We look forward to continuing the collaboration and building further on the work they continue to do in the field of cancer-associated fibroblasts.”
Image: A human head and neck cancer under the microscope. Courtesy: University of Southampton