Statement from the CEO

Currently, there is a lack of effective drugs to minimize the acute tissue damage that occurs in the heart during a heart attack. Relatively new knowledge shows that a large part of the injury is caused by an inflammatory process in connection with the blood beginning to flow into the heart’s blood vessels again after the patient has undergone life-saving balloon expansion. This knowledge provides completely new opportunities to develop drugs that protect the heart tissue. The goal is to save lives and reduce the long-term damage that contributes to both new infarcts and chronic heart failure. 

Kancera’s Fractalkine blocker KAND567 is developed to effectively and selectively reduce the inflammation of the heart and vessels after a heart attack. In several animal studies we have also been able to show that KAND567 reduces the injury area by up to 50 percent, and during the past year we have completed a phase I study in which the drug candidate showed a good safety profile at dose levels that are considered sufficient to achieve a pharmaco-logical effect. In addition, we have achieved significant progress in the development of a large-scale production method. The international interest in our project is increasing, and in conjunction with the annual JP Morgan Congress in San Fransisco in January, we had the opportunity to meet a number of global pharmaceutical companies that wanted to know more about KAND567 and our plans for the future.

The progress of recent years in the Fractalkine project, with KAND567 at the forefront, has led to the company for some time allocating virtually all its internal resources to this area. The next step is to evaluate intravenous dosage in a supplementary phase I study, in healthy subjects, after which the project is expected to enter phase II. In the first patient study, KAND567 will be administered intravenously to myocardial infarction patients. Results are expected to be available in the second half of 2020. In the long term, we see great opportunities for also developing the drug candidate against chronic inflammatory diseases and certain types of cancer. The cancer area is considered increasingly interesting. Recently we presented results from analyses of lymphoma patients’ immune cells that show that the Fractalkine system is activated in chronic lymphocytic leukemia, diffuse large cell B cell lymphoma and Hodgkin’s lymphoma.

The development of Kancera’s other pipeline projects will depend on external collaborations. In December, we announced that Grünenthal – a leading pharmaceutical company in pain management – is taking over the responsibility for preclinical research on our HDAC inhibitors. Grünenthal is entitled to later acquire the HDAC substances, with the aim of developing one or more new and potentially disease-modified drugs for neuropathic pain. The total contract value amounts to approximately SEK 340 million. In addition, Kancera is entitled to sales-based royalties.

Our financial position was strengthened in 2018 through a new share issue and through an agreement with the American investor Global Corporate Finance (GCF) on future targeted new issues to a maximum amount of SEK 60 million. We believe that the agreement, which is free from stock loans and warrants, offers a cost-effective alternative to traditional issues. Capital contributions from GCF are intended to be used for clinical studies and for the company’s operations.

The global market for drugs in acute myocardial infarction is estimated by Zion Market Research to be approximately SEK 12 billion, with an estimated growth of 40% by 2022, but currently there are no drugs that can counteract the inflammation-related damage to the heart in the acute phase. Such a drug would have the potential to significantly further expand the market. We look forward to launching a Phase II study of KAND567 in the second half of 2019 in myocardial infarction patients and the results are expected to be available about one year later. Positive study results would be transforming for Kancera. Not only for the continued development of our most advanced drug candidate in the heart attack area, but also for development in other commercially attractive areas where the need for improved treatments is great.

Thomas Olin
CEO Kancera AB (publ)
February 2019