Cancer Research UK and Cancer Research Technology (CRT), the charity’s development and commercialisation arm, are to undertake a phase I clinical trial of an investigational monoclonal antibody1 drug from Merck KGaA, Darmstadt, Germany, called DI-B4 – it is announced today (Monday).
DI-B4 is the fourth anti-cancer drug to enter Cancer Research UK’s Clinical Development Partnerships (CDP) programme2 – 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 Unit3. 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 five4 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.”
For media enquiries, please contact the Cancer Research UK press office on 020 7061 8309 or, out of hours, the duty press officer on 07050 264 059.
This trial is not open to recruitment. When it is open, more information will be available on Cancer Research UK’s patient information website CancerHelp UK
About monoclonal antibodies
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
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. More information about the programme can be found here.
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.
Where is the trial?
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.
About 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 UK