WILEX has focused on oncology since its formation, pursuing the development of new cancer therapies to enable efficacious well-tolerated treatments. A high priority is placed on patients’ quality of life. Over the years, the business model has been expanded to include new technologies intended to raise WILEX’s profile in oncology and improve its competitive position. WILEX offers a combined portfolio of both therapeutics and diagnostics. Its aim is to help oncologists and other specialists administer targeted treatments to carefully diagnosed patients and offer therapy options tailored to different types and stages of cancer.
Antibodies are large macromolecules and play a key role in the body’s immune system. The immune system produces these protein molecules (known as “immunoglobulins”) to identify and destroy foreign organisms such as viruses or bacteria which can cause disease. Antibodies are able to identify and bind to specific molecular structures called “antigens”. This binding triggers certain physiological processes which render the pathogen harmless and therefore protect the organism from contracting respective particular disease. Antibodies are very specific and can detect even small molecular differences.
For cancer diagnosis and therapy, specialised “monoclonal” antibodies are manufactured artificially in the laboratory. Monoclonal antibodies are produced by cells created when an antibody producing cell (such as a B lymphocyte) fuses with an immortalised cancer cell. This procedure is carried out in the laboratory and produces a hybrid cell (hybridoma) possessing the properties of both cells. Since these cells originate from the same cell, they are all identical and are therefore described as “monoclonal”. Monoclonal antibodies can be developed to target a specific antigen on the surface of cancer cells.
There are different types of monoclonal antibodies. Originally, monoclonal antibodies were generated from non-human sources such as mice (and termed “murine” antibodies). However, the human immune system identifies murine antibodies as foreign and initiates an immune response against them. Efforts have therefore focused on developing more human-like antibodies. One possibility is for instance chimeric antibodies. They possess a murine variable part and a human constant part. Chimeric means “composed of genetically different tissue or genes”.
Insights into the properties of antibodies together with the possibility of artificially creating human antibodies provided the theoretical foundation for a new kind of antibody-based immunotherapy. This new approach led to the search for tumour-specific antigens to provide targets for the specific deployment of monoclonal antibodies. If successful, the production of antibodies that target antigens expressed only on tumour cells and not on healthy cells enables the development of new, highly-specific cancer therapies. These can combat tumour cells with maximum efficacy while also possessing a low side-effect potential. Therapies based on antibodies are currently considered one of the most promising areas of treatment in medicine.
WILEX licensed the chimeric antibody Girentuximab from Centocor, Inc. (USA) and Leiden University (the Netherlands) in 2001. This highly-specific antibody binds to the protein carbonic anhydrase IX (CA IX) on the cell surface of tumour cells. This antigen is expressed on the cell surface in over 90% of all clear cell renal cell carcinomas (RCCs), but is not expressed in normal kidney tissue. CA IX is also expressed on a variety of other solid tumours, including cervical, bladder, colon and non-small cell lung cancer.
WILEX radiolabelled the antibody Girentuximab with iodine-124 and developed under the product name REDECTANE® a diagnostic agent for the identification of clear cell RCC. 124I-Girentuximab binds to the antigen CA IX. Accumulation in the diseased kidney can be visualised by means of a position-emission tomography (PET) scan and localised using computer tomography (CT). REDECTANE® successfully completed a Phase III registration trial.