Our Drug Development Office (DDO) works closely with academic and industry partners to bring novel and innovative research to the oncology field.
In our portfolio of 30 projects, we currently have 13 trials open to recruitment throughout the UK including two paediatric studies, two glioblastoma trials and one in pancreatic cancer. Two projects have received MHRA approval to open over the next couple of months.
In partnership with AstraZeneca, we recently opened a new study (AZD0424), which is the first of its kind in early phase oncology. It involves an adaptive study design – where the planned treatment to be given to patients is modified as the trial progresses. This means we will be able to monitor the data we receive in the first phase of the trial and feed this back into the study to adapt the types of drugs we use in the second part as the trial is happening. This should hopefully enable a more streamlined way to test drugs in the future. We are also investigating a first-in-class molecule targeting lactate metabolism as a novel therapeutic approach to cancer (AZD3965 (MCT-1)).
Recently the DI-B4, a monoclonal antibody, received regulatory approval. This is used to treat patients with indolent B-cell malignancies. B-cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukaemia are the most common types of haematological malignancies in adults in the West, yet both are considered incurable.
The DI-B4 project exemplifies our manufacturing capabilities and our ability to provide expertise in a competitive field while attracting company and academic interest into this innovative model of early phase development. This project was brought to the DDO via the Clinical Development Partnerships (CDP) initiative by Merck KGaA. CDP is a joint initiative launched in partnership with our commercial arm, Cancer Research Technology. The programme allows us to form strong links with industry to take promising drugs forward into early phase clinical trials that otherwise would not be developed by pharmaceutical companies.
Working closely with Merck KGaA, the DDO’s Biotherapeutics Development Unit (BDU) has transferred the manufacturing process for this antibody to the unit. The BDU was successful in modifying and adapting the process to ensure consistent and robust antibody supply for a Phase I clinical trial. The £18 million state-of-the-art GMP (Good Manufacturing Practice) facility is the only stand-alone facility of such size owned by a non-commercial organisation. This purpose-built unit offers operational flexibility and holds a MHRA Investigational Medicinal Product (IMP) licence.
The clinical trial is expected to open at the lead site in Southampton in June 2013 under Chief Investigator Dr. Andrew Davies. Participating centres include The Christie under Principal Investigator Professor John Radford and Liverpool under Principal Investigator Professor Andrew Pettitt.
If you would like to know more about the project, please contact the Project Manager, Tara Gipp. If you would like to know more about applying for DDO project support, please contact Kate Searle.
# DI-B4 is an anti-CD19 IgG1 monoclonal antibody de-immunised with potent antibody-dependent cell-mediated cytotoxicity (ADCC) but minimal complement dependent cytotoxicity (CDC) activity
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