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DI-B4 is the fourth anti-cancer drug to enter Cancer Research UK’s Clinical Development Partnerships (CDP) programme** - an initiative which allows companies to retain the rights to a treatment whilst enabling the charity to take on its early development work. DI-B4 is the first monoclonal antibody to join the scheme.
DI-B4 binds to the CD19 protein, found on B-cells, and is thought to recruit cells from the immune system to attack the tumour. It is hoped that it may one day help patients with leukaemia and lymphoma who do not respond to existing therapies. Currently, the standard treatment for B-cell lymphoma targets the CD20 protein.
DI-B4 will be one of the first drugs to be manufactured at Cancer Research UK’s new state-of-the-art, £20 million Biotherapeutic Development Unit***. After pre-clinical work on it has been completed, it will be taken into a phase I trial in around 20-40 patients with advanced B-cell lymphoma - a cancer of the white blood cell.
The trial will be managed by Cancer Research UK’s Drug Development Office and will take place at up to five**** hospitals across the UK. Under the terms of the partnership, Cancer Research UK will fund the study through early clinical development. Merck KGaA will then have an option to take forward and commercialise the drug in exchange for future payments to the charity. If Merck KGaA elects not to progress the programme, the rights to the molecule will be given to CRT to secure an alternative development partner.
Dr Nigel Blackburn, director of Cancer Research UK’s Drug Development Office, said: “We’re very excited to be entering this venture with Merck KGaA. Equipped with the knowledge they have gained from creating the antibody, we will use our brand new manufacturing facility to develop it into a potential new treatment for cancer patients.”
Dr Keith Blundy, chief executive of CRT said: “In an increasingly competitive market place, pharmaceutical and biotechnology companies have to focus strategically on certain areas of research and hold back on others. This deal demonstrates how we can work together to progress cancer drugs.”
Dr Andrew Davies, Cancer Research UK senior lecturer in medical oncology at University of Southampton, who will run the phase I trial at Southampton General Hospital, added: “Existing treatments which target cancerous cells and draw in the body’s immune system can be extremely helpful. But we still need to search for alternative approaches for patients with B-cell cancers which have not responded to existing treatments. We hope that DI-B4 will have the same effects in patients as it has shown in the lab.”
Notes to Editors
*Similar approaches which use monoclonal antibodies to trigger the immune system to target cancer cells include rituximab for non Hodgkin's lymphoma (NHL) and some types of leukaemia and alemtuzumab for chronic lymphocytic leukaemia (CLL).You can find out more about these cancers on Cancer Research UK’s patient information website CancerHelp UK here: www.cancerhelp.org.uk
**About the CDP programme The Clinical Development Partnerships programme was launched in 2006 to increase the number of new treatments for cancer patients by taking reprioritised agents from industry and putting them into clinical trials. Following the first deal in 2008, one of these drugs is soon to enter a clinical trial and a further one is at late stage of pre-clinical development.
***Cancer Research UK’s biotherapeutic development unit (BDU)The BDU is Cancer Research UK’s new state-of-the-art, biotherapeutic development unit built on the charity’s London Research Institute Clare Hall site. The unit has been designed for the development and GMP manufacture of investigative biotherapeutic drugs, including viruses for use in clinical trials.
****The phase I trial will take place at Southampton Cancer Research UK Centre, the Christie Hospital NHS Foundation Trust Hospital in Manchester, Barts and the London NHS trust, and The Royal Liverpool University Hospital. More information about the trial will be available on Cancer Research UK’s patient information page CancerHelp UK when the trial is ready to proceed. You can visit this page here: www.cancerhelp.org.ukAbout Leukaemia and lymphoma Leukaemia and lymphoma are haematological malignancies. These are cancers of the bone marrow or lymphatic system, where blood cells are made. Normally, blood cells are produced in a controlled way. In these cancers, too many blood cells are made and the cells don't work properly. You can find out more about these cancers on Cancer Research UK’s patient information website CancerHelp: www.cancerhelp.org.uk
About Cancer Research UK’s Drug Development Office
Cancer Research UK’s Drug Development Office has an impressive record of developing novel treatments for cancer. It currently has a portfolio of approximately 40 new anti-cancer agents in preclinical development, phase I or early phase II clinical trials. Since 1982, the Cancer Research UK Drug Development Office has taken over 100 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 new treatment for brain cancer. Six other drugs are in late development phase III trials. This rate of success is comparable to that of any pharmaceutical company. Further information about the drug development office can be found here.
About the University of Southampton's School of Medicine
Established in 1971, the University of Southampton's School of Medicine is at the forefront of medical and basic science research. It is one of the top ten UK medical schools for research income and high quality outputs, and its innovative educational programme has been rated excellent (the highest possible rating) by the government-backed Quality Assurance Agency.
The School is committed to academic excellence in all aspects of research and medical education. It operates a highly focused research strategy with large interdisciplinary Research Divisions that bridge traditional subject boundaries. These divisions provide a critical mass of research resources and explore areas of common intellectual interests around important clinical problems. There are six Research Divisions and an Education Division reflecting the School's major strengths: Human Genetics; Community Clinical Sciences; Infection, Inflammation and Immunity; Cancer Sciences; Developmental Origins of Health and Disease; and Clinical Neurosciences.
