Trial for potential new drug that could help immune system fight cancer

Cancer Research UK's Centre for Drug Development (CDD), in partnership with Amgen Inc., has launched a new clinical trial to test a drug that could stop a patient's immune system from protecting tumours.

Cancer Research UK scientists are studying Amgen's experimental cancer drug , called AMG319, to find out if it removes the defence shield that hides cancer cells from the immune system. It targets a protein called PI3K delta leading to destruction of the cancer cells when tested in the laboratory.

The Phase II trial, taking place at Poole Hospital, Southampton General Hospital, and the Clatterbridge Cancer Centre/Aintree University Hospital, looks at the effects of giving this drug to patients with a type of head and neck cancer known as squamous cell carcinoma (HNSCC), to determine whether it affects their immune response.

There will be around 54 patients with HPV-negative* HNSCC of the lower and upper parts of the throat (hypopharynx and oropharynx) or mouth in the study. Patients will be randomly assigned to receive either AMG319 or a placebo, during the regular break from treatment to avoid disruption to a patient's care.

It is the 10th treatment to enter Cancer Research UK's Clinical Development Partnerships (CDP) scheme.

CDP is a joint initiative between Cancer Research UK's CDD and Cancer Research Technology, aiming to increase the number of cancer clinical trials and to progress promising anti-cancer agents by working in partnership with pharmaceutical companies.

Professor Christian Ottensmeier, trial lead from the University of Southampton and the Southampton Experimental Cancer Medicine Centre, said: "This is a really exciting trial because we're using this drug in solid tumours for the first time. It also tries a whole new concept of cancer therapy in solid cancers for the first time. We hope that after taking the drug, patients will have more cancer fighting immune cells in their tumour. We will study in detail how the immune cells behave before and after AMG319 and whether they have become more effective."

Dr Emma King, clinical lead at the Poole Hospital, said: "I am really pleased that this trial gives our head and neck cancer patients and opportunity to get this new drug."

Tony Hoos, Vice president of Medical, Europe at Amgen, said: "The intersection of immunology and oncology represents one of the most promising approaches which may have a significant impact for patients with cancer today.

"We value the work that Cancer Research UK has done to make it possible to develop this promising drug to the next stage. This new trial will give us a better understanding of how AMG319 works, helping us learn more about its potential in patients who might benefit."

Dr Nigel Blackburn, Cancer Research UK's director of drug development, said: "We're delighted that the collaboration between Amgen and our Centre for Drug Development is moving into Phase II trials. It means we're getting closer to providing a new treatment for cancer patients.

"Teaching the body's immune system to fight cancer is a promising area of cancer research and we're excited to see how this drug may help."


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Notes to editors:

*Some types of head and neck cancer are caused by a virus called human papillomavirus (HPV) but most are not. This study is including only people whose cancer has not been caused by the virus – those who are HPV negative.

About Cancer Research UK's Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. It currently has a portfolio of around 30 new anti-cancer agents in preclinical development, phase I or early phase II clinical trials. Having supported drug development since the 1980s, the Cancer Research UK Centre for Drug Development, formerly the Drug Development Office was established in 1992. It has taken over 120 potential new anti-cancer agents into clinical trials in patients, five of which have made it to market and many others are still in development. These include temozolomide, a drug discovered by Cancer Research UK scientists, that is an effective treatment for brain cancer and abiraterone, which is used to treat prostate cancer. This rate of success is comparable to that of any pharmaceutical company.

About Cancer Research Technology

Cancer Research Technology (CRT) is a specialist commercialisation and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is a wholly owned subsidiary of Cancer Research UK, the world's leading cancer charity dedicated to saving lives through research. For more information visit

About the ECMC network

The Experimental Cancer Medicine Centres (ECMC) Network is an initiative funded in partnership between Cancer Research UK and the four Health Departments of England, Scotland, Northern Ireland, and Wales. Launched in 2007, this £35 million infrastructure award supports a network of 18 adult and 9 paediatric Centres of Excellence distributed throughout the UK. The ECMC Network strives to push the boundaries of cancer care, by bringing together world-class pockets of scientific and clinical expertise in each of its adult and paediatric ECMCs whilst providing industry partners with the opportunity to obtain access to cutting-edge, early-stage innovation. In 2014-15 alone, ECMCs leveraged over £73,000,000 from commercial partnerships, with over 2,500 patients recruited onto the 389 ECMC-supported clinical trials. Find out more at or @ECMC_UK

About Cancer Research UK

  • Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research.
  • Cancer Research UK's pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
  • Cancer Research UK receives no government funding for its life-saving research. Every step it makes towards beating cancer relies on every pound donated.
  • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last forty years.
  • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK's ambition is to accelerate progress so that 3 in 4 people will survive their cancer for at least 10 years within the next 20 years.
  • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
  • Together with its partners and supporters, Cancer Research UK's vision is to bring forward the day when all cancers are cured.

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