Therapeutic Approach

About Cancer
Traditional Cancer Therapies (“Seek and Destroy”)
Paradigm Shift in Cancer Therapies (“Target and Control”)
The WILEX Approach
Monoclonal Antibodies
Inhibitors of Tumour Biological Functions
Diagnostic before surgery

About Cancer

Cancer is a group of diseases characterised by the uncontrolled growth of cells with abnormal functions which have acquired invasive properties and may spread throughout the body. Cancer typically arises when the immune system fails to recognise and eliminate such abnormal cells. The mechanisms which lead to the disease are complex and vary by the type of cancer.

Individual cancer cells may detach from the primary tumour, spread to other parts of the body and grow into new, distant tumours in a process referred to as metastasis. Most deaths from solid tumours are not caused by the growth of the primary tumour, but result from its metastasis.

Cancer afflicts millions of people worldwide and is currently one of the leading causes of mortality in industrialised countries. Despite a general movement towards healthier lifestyles, improved diagnosis and noteworthy success in the treatment of certain types of cancer, the incidence of the disease is expected to remain one of the leading causes of death, primarily due to the aging of the population and environmental changes.

Traditional Cancer Therapies (“Seek and Destroy”)

Traditional treatments for solid tumours primarily include surgery, radiation therapy and chemotherapy, used either individually or in combination. This is often referred to as the “seek and destroy approach”. Although generally effective in decelerating the progression of the disease and prolonging cancer patients' lives, traditional cancer therapies have significant limitations both in terms of efficacy and safety. Surgical removal of solid tumours generally cannot ensure the eradication of all malignant cells, especially when the cancer has metastasised. Radiation therapy often results in severe side effects and has only limited utility in treating widespread metastases. Chemotherapy often provides only temporary relief from most types of solid tumours, and the disease frequently reappears or resumes its progression within months or years after therapy. Moreover, subsequent chemotherapeutic treatment can become less effective as the patients' tumour cells often develop resistance to the drug regimen over time. In addition, since chemotherapeutic drugs are not sufficiently specific to cancer cells, their administration cannot avoid affecting normal cells, which often results in side effects such as nausea, vomiting and hair loss as well as life-threatening side effects such as liver, cardiac, bone marrow and blood cell toxicities. Such side effects may necessitate dose reduction, which ultimately limits the effectiveness of treatment.

Paradigm Shift in Cancer Therapies (“Target and Control”)

In recent years there has been a paradigm shift in cancer therapy driven by scientists, oncologists and the pharmaceutical industry. The traditional "seek and destroy" approach is being replaced by or combined with new non-cytotoxic therapies designed to “target and control” the disease.

Therefore, novel cancer therapies are increasingly aimed at targeting tumour cells directly to block biological functions of cancer cells which enable them to invade surrounding tissue and metastasise. Therapeutic agents which more specifically attach to the tumour cell to block or destroy it without affecting other cells allow treatment with less severe side effects and/or chronic application in order to control the disease while providing a good quality of life. In addition, based on the scientific findings that cancer cells employ various mechanisms to grow and spread in the body, cancer therapies have been continuously moving toward a combination of several therapeutic approaches acting at multiple points of primary tumour growth and the metastatic process.

The WILEX Approach

WILEX aims at developing novel compounds for the treatment of cancer, which are designed to address individual tumour-specific targets. Thus the Company seeks to develop novel cancer therapeutics with increased efficacy and reduced side effects compared to traditional cancer therapies. WILEX searches for targets associated with the formation or progression of cancer. Based on this knowledge of targets WILEX furthermore develops a diagnostic candidate which should be able to indicate malignant tumours. The Company believes that two of the most promising emerging cancer therapies involve, (i) monoclonal antibodies that bind to tumour cells and stimulate the body's immune system to destroy the malignant cells of the tumour or (ii) inhibitors of tumour biological functions that reduce tumour growth and metastasis. WILEX’s product portfolio currently consists of five candidates – two antibody based programmes and three small molecules programmes.

Monoclonal Antibodies

Antibodies are part of the body's principal defense mechanism against disease-causing foreign organisms, such as virally infected cells and bacteria. Antibodies are able to recognise a specific molecular structure called an antigen and bind to that antigen. The binding triggers one or a number of physiological processes, which protect against disease. Antibodies are highly specialised and are capable of detecting the most subtle of molecular differences. Individual antibodies produced from a single cell-type are called monoclonal antibodies and can be generated against a specific target on cancer cells. This specificity and the fact that antibodies can be manufactured in large quantities with consistent quality make them attractive candidates for therapeutic substances. The understanding of the properties of antibodies and the possibility to produce human antibodies artificially provided the theoretical basis for the emergence of antibody-based cancer immunotherapeutics. This new approach led to a search for tumour-specific antigens to which monoclonal antibodies could be directed. A monoclonal antibody directed to an antigen expressed only by a malignant cell could form the basis of a therapy with few, if any, side effects.

Inhibitors of Tumour Biological Functions

Cancer cells use a variety of biological systems to grow and to spread throughout the body. Through abnormal function of signalling pathways the cancer cells enable themselves to proliferate and to divide faster than normal cells. To sustain their growth cancer cells trigger angiogenesis which provides the tumour with increased blood flow and therefore provides more oxygen and nutrition. Proteases are overproduced to enable the cancer cells to invade surrounding tissue and gain access to lymph and blood vessels in order to metastasise. Specific inhibitors which are linked to a multitude of biological processes such as cell division, cell differentiation and cell death, would lead to the control of tumour growth and inhibition of metastasis.

Modern imaging procedures such as CT or MRI scans have currently difficulties to provide a clear indication of whether a renal tumour is benign or malignant. Biopsy is a reliable procedure and may increase the risk that malignant cells spread from the kidney. Only histological examination following surgical removal of the kidney provides definite information on the nature of renal mass.

WILEX is developing a diagnostic agent which only binds to clear cell cancer cells and not to other tissue. This process can be visualised by means of positron emission tomography (PET) and in combination with CT the accumulation in the tumour tissue can be localised. The diagnostic candidate could therefore enable reliable pre-operative diagnosis by means of PET/CT.