Statement from the CEO
“Kanceras research is recognized for “outstanding quality” by the European Society of Cardiology”
Each year, 2 million people suffer from heart attacks in the United States and the EU. A quarter of these die or suffer from further serious heart disease within five years. The need for new treatments that can reduce the risk of complications and relapses is therefore great. Kancera’s drug candidate KAND567 prevents the injuries that normally occur in a heart attack in a whole new way, something that is now becoming internationally recognized.
When the European Society of Cardiology (ESC) has its annual conference in September, Kancera’s research has been selected for its “outstanding quality”. ESC is the biggest scientific meeting of the year in the cardiovascular field, and the meeting brings together both researchers and global industrial players. This recognition means that we will present our preclinical results for KAND567 during a session on future treatments for acute heart disease.
The Fractalkine project, with KAND567 at the forefront, is of interest because our approach builds on the relatively new insight that the acute inflammation that occurs in a heart attack actually causes half of the serious tissue damage in a heart attack. We have reported the overall results in the past, but our position is strengthened when we now have the opportunity to describe them in more detail and to discuss them with the world’s leading researchers in the field.
At the same time, the development of the project continues. During the second quarter we have both started the Phase Ib study of intravenously administered KAND567 and obtained the first interim results. In this study, KAND567 is given as an infusion to 27 healthy subjects to evaluate safety, tolerance and exposure. The purpose is to show that intravenously administered KAND567 has as good a safety profile as when the drug candidate is given orally.
The first interim results from the phase 1b study were positive and showed that KAND567 has a good safety profile for shorter infusions and that the calculated effective plasma concentration can be achieved according to plan. However, the follow-up part of the study showed that there was local irritation at the infusion site when the infusion was given for a prolonged period. This is likely to be avoided if you adjust the ratio of the concentration to the speed applied by KAND567. As such an adjustment requires a supplementary approval from the Swedish Medicines Agency, the final results of the phase 1b study will be completed somewhat later than we previously planned for, and we now expect to be able to report the results in November this year.
In connection with the start of the phase 1b study, the third and final payment to Acturum AB for the Fractalkine project was activated. The payment was completed after the end of the second quarter, in mid-July, through a new issue of two million shares to Acturum AB. During the second quarter, Kancera AB also completed two private placements of 5,000,000 shares each to Global Corporate Finance, supported by authorization from the Annual General Meeting on May 27, 2019.
In parallel with the development of KAND567, we recently put forward another drug candidate in the Fractalkine project, KAND145. With another drug candidate, it is possible to develop separate drugs for different uses. At the end of the second quarter, we were able to report that two patent applications linked to KAND567 and KAND145 entered the international phase, which contributes to a stable foundation for continued product development.
However, the focus now is on completing the phase 1b study with intravenously administered KAND567 and then purposefully working to demonstrate in a phase IIa clinical study the cardiac protective effect of KAND567 in patients affected by infarction.
Solna, 23 August 2019
Thomas Olin, CEO