Market and medical need

Kancera’s primary market is based on business-to-business sales of drug candidates for further clinical development and marketing by an internationally established pharmaceutical company. The dynamics and payment models for this type of agreement are dealt with under “Business and revenue model” (see “About us”). The underlying demand for Kancera’s drug candidates is driven by the medical need to improve how effectively cancers are controlled.

Development is moving towards:

■ Diagnostic methods that provide genetic information concerning exactly which factors in the individual patient’s cancer are driving the disease and whether there are mutations that mean that a traditional drug is not effective.

■ Drugs that attack the cancer’s driving mechanisms, overcome the causes of resistance to therapy and act selectively on cancer in order to reduce side effects that otherwise contribute to increased sickness and high healthcare costs.

This means that more patients will be able to be offered individualized cancer treatment that results in a longer and better life.

The number of drug projects in the area of cancer has steadily increased, but many of these are working along the same lines as others (source: lifescivc.com/2012/06/cancer-drug-targets-the-march-of-the-lemmings/), which is why the pharmaceutical companies are now setting their sights on drug candidates that stand out from the mainstream and have the potential to fundamentally change the way in which life-threatening diseases are treated. Drugs targeting ROR qualify for such interest from the pharmaceutical industry and as a biotech company, Kancera is leading this development.

Kancera’s focus is on target molecules in the cancer, which opens up the possibility of interrupting the resistance of life-threatening forms of cancer and also the development of diagnostics that allow early identification of patients that will benefit from the new treatment.

Kancera is currently evaluating applications of future drugs targeting ROR and PFKFB in:

■ Solid tumors in the pancreas, lungs, bowel and breast. The first three of these cancers are among the four cancers that cause the most deaths in both women and men; after lung cancer, breast cancer is the type of cancer that causes the most deaths among women.

■ Types of leukemia such as chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML), which are the most common chronic and acute types of leukemia in adults respectively.

These cancer indications each represent a global market in the order of SEK 3.5 billion to in excess of SEK 10 billion annually (source: Global Data). A drug that can help extend life by six months at a cost of less than around SEK 1 million is currently judged by pricing authorities such as TVL to represent a significant value for the patient and for society. Kancera’s own published results and also publications by independent research teams within the areas of ROR and PFKFB support the idea that future drugs that act on ROR and PFKFB have the potential to improve the treatment of the cancers mentioned above. How well this potential can be translated into clinical practice remains to be shown in clinical studies.

The industry’s interest in rare diseases – known as orphan diseases – has also increased in recent times in view of the fact that they represent substantial medical needs, while at the same time the patient group is often clearly defined, making clinical studies easier. As a result, authorities are facilitating the development and protection of products to treat these diseases. In preclinical studies Kancera’s projects have been shown to be a possible means of treating a number of types of cancer meeting the requirements for classification as orphan diseases (in the US, fewer than 200,000 individuals affected).

Two examples of cancers where there is a need for improved treatments and which qualify as orphan diseases are given below; these are among the types of cancer being addressed by Kancera’s drug projects.

Pancreatic cancer affects more than 100,000 patients annually in Europe and the US. The survival rate among these patients five years after diagnosis is less than two percent. A combination of chemotherapy and radiotherapy is used to allow surgery to remove the tumor. The drug treatment aimed purely at preservation of life mainly consists of various types of cell toxins (gemcitabine and FOLFIRINOX containing combinations of fluorouracil, irinotecan and oxaliplatin). At present, there is no recommended target-seeking drug for the treatment of pancreatic cancer. The market for pancreatic cancer in the US amounted to USD 781 million in 2009 with expected growth of between -4 and +8% until 2017 (source: Global Data Healthcare).

Chronic lymphocytic leukemia (CLL) affects around 30,000 patients in Europe and the US annually, making CLL the most commonly occurring chronic type of leukemia. Traditional treatments for types of cancer such as CLL are currently not sufficiently effective or selective. The most common type of treatment for CLL consists of a combination of the antibody rituximab and cytostatics such as fludarabine and cyclophosphamide. This combination of drugs is used in 19 percent of treatments in the seven countries representing the largest pharmaceutical markets. After initial treatment around 50 percent of patients suffering from the disease become symptom-free, but after just four years around 80 percent have a recurrence of clear symptoms of the cancer. New, increasingly harsh treatments are required in this phase of the disease, but the treatment results become progressively worse. When fludarabine no longer has any effect on the disease the patient is seriously threatened, since no targeted drug is available for this phase of the disease. The market for CLL is estimated at USD 800 million in 2017 (source: Global Data Healthcare 2013). Kancera also believes there is good potential to expand into other cancers in view of the fact that ROR1 is found in at least eight other blood malignancies (see figure in the section on Kancera’s ROR inhibitors project).


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