Interim report for the third quarter 2019, 1 January – 30 September 2019
Significant events during the third quarter
Significant events after the end of the third quarter
"Funding for the trial of KAND567 with life-saving potential following myocardial infarction and patent strategic decisions to strengthen the HDAC project in the fight against nerve pain"
The recently announced, fully guaranteed issue enables Kancera to conduct planned clinical trials of the drug candidate KAND567 which could normalize and extend the lives of patients affected by a major heart attack. The financing consists of a bridge financing of approximately SEK 14.0 million for the completion of the Phase Ib study and a new issue of Units of approximately SEK 61.4 million during the first quarter of 2020, including the opportunity to redeem an attractive priced option during Q2 2020. Together, this is estimated to add up sufficient funds to carry out the Phase IIa study.
According to our overall schedule, the development program continues for KAND567, which protects both the heart and blood vessels from injuries in connection with acute and chronic heart disease, although there have been some delays in certain interim goals during the quarter.
Early in the summer, the first interim results from the Phase 1b study showed that we had achieved the goal of reaching the heart with the estimated effective concentration of KAND567 already within five minutes and that the safety profile was satisfactory during a short period of intravenous infusion. However, a local irritation occurred at the infusion site when the infusion was given for an extended period of time. The concentration and infusion rate correction tested during the summer produced better results, but the tolerance was not good enough for an intravenous infusion over three days. Together with our clinical advisors, we have therefore made the decision to further develop the dosing strategy by switching to a combination of shorter intravenous infusion and up to three days of oral treatment.
With a retained plan to apply for a Phase IIa study on myocardial infarction in the second quarter of 2020, we are now going to Finland to complete the Phase Ib study in February 2020. The reason for this is that Finland offers attractive timeframes for conducting a high-quality study with a maintained budgetary framework.
Kancera already has good Phase 1 data for orally administered KAND567, and the new proposed dosage is consistent with clinical practice for care following myocardial infarction. Our overall assessment, based on all available data, is that there is strong support that the new dosing strategy will provide the desired effect and safety.
The interest in the role of inflammation in myocardial infarction in general, and the importance of the fractalkine receptor in particular, remains high. In early September, we gave the first scientific presentation of our data from preclinical studies of KAND567 at the world's largest cardiac congress, ESC Congress 2019 in Paris. The congress attracted over 33,000 participants and Kancera's research was presented during the main session for scientific progress in the next generation of treatments for acute heart disease. The reception was very good among the researchers, companies and key opinion leaders who attended and the dialogue with key people continued during the American Heart congress (AHA) earlier this week. In connection with the meeting, Kancera's presentation was also highlighted in the international trade press, where BioCentury, BioSpace and Labiotech all referred to our research results. You may find a link to a video recording of the presentation at ECS here.
When this year's Nobel Prize in Medicine was presented at the beginning of October, we received yet another proof that our research is linked to major scientific breakthroughs. This year, the discovery of how cells sense and adapt to oxygen supply was rewarded, and in particular, focus the interest on proteins regulated by the oxygen-sensitive factor HIF-1α. Among them are the Fractalkine receptor CX3CR1 and the enzyme PFKFB3. In our ongoing work to pursue KAND567, it is beneficial that more and more people see the importance of inflammation and the Fractalkine system in the oxygen deficiency that occurs after a heart attack.
In parallel to the development of KAND567, our collaboration with Grünenthal continues on our HDAC inhibitors for the treatment of pain and inflammation. After the end of the quarter, the decision was made to strengthen the patent strategy within the collaboration, and, as part of this, we withdrew a patent application for a series of HDAC inhibitors in order to be able to submit a new supplementary application at a later stage. Existing collaboration agreements have been supplemented to allow both parties to reap the benefits of this revised patent strategy. Constantly reviewing and strengthening the patent strategy is a natural part of the work in this type of drug development project. Together with Grünenthal we look forward to achieve a breakthrough in the fight against nerve pain.
Solna, November 22, 2019
Thomas Olin, CEO