Cancer Research UK and CRT to undertake phase I clinical trial of DI-B4

Deal struck for new investigational anti-cancer drug to target leukaemia and lymphoma

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."