”The second quarter was yet another eventful quarter when Kancera made significant progress in our ongoing clinical studies with our candidate drugs KAND567 and KAND145:

• In May, we reported positive top line results from the KAND145 phase I-study in healthy subjects. A very important milestone as this is the first clinical study with KAND145, our next generation fractalkine blocker that is of great strategic importance for the company. The study results verify that KAND145 has a similar mode of action as KAND567 and demonstrate that KAND145 is safe and tolerable at the dose levels that are expected to be therapeutically effective against the disease conditions Kancera is focusing on.
• In the beginning of July, we reported that the first part of the KANDOVA study was successfully completed. KANDOVA is a combined clinical phase Ib/IIa study with KAND567 in ovarian cancer. The completion of phase Ib means that the recommended dose for part two of the study, phase IIa, has been set. Also, this is a very important milestone as KANDOVA is our first clinical study in cancer and we have now demonstrated that KAND567 has a favorable safety profile at the dose levels expected to be effective against ovarian cancer. With the primary objective for phase Ib achieved we are now proceeding to phase IIa. The study protocol allows for up to 30 patients to be enrolled in the two study phases. The definite number of patients to be enrolled during phase IIa are continuously being assessed and will be decided during the second half of 2024.

Put together, these important results mean Kancera has taken a major step forward with our fractalkine program. The results validate our strategy, which is to lead the clinical development with KAND567 and use this candidate drug to evaluate the treatment concept of fractalkine blockers, in parallel with the first clinical studies of KAND145. We are now continuing in line with this strategy and are preparing to switch over to KAND145 in upcoming clinical studies. 

Our development activities in the cardiovascular field are also progressing according to plan. At the end of 2023, we reported positive topline results from the FRACTAL study, a clinical phase IIa study with KAND567 in myocardial infarction patients undergoing primary PCI. The topline results showed that our fractalkine blockers have the potential to significantly reduce the risk of left ventricular thrombosis in ST-elevation myocardial patients that undergo primary PCI, without an increased risk of bleedings.

After the publication of these results we have continued our analysis, e.g. through detailed analyses of pathways controlling inflammation and coagulation. Our detailed analysis supports our reported results and in addition enables us to explain the mode of action and unique characteristics of our drug candidates. This will help us in our product positioning and design of upcoming clinical studies. After the reporting period we also announced that the study results from the FRACTAL study will be presented at the European Society of Cardiology’s conference in London in September, the largest conference in the world within the field of cardiovascular medicine. 

With the progress made during the first half of 2024, we have significantly advanced our clinical development program and demonstrated that KAND567 and KAND145 are two qualitative candidate drugs representing a new class of drugs. Having a unique mode of action and favorable safety profile, we see good opportunities for a clear positioning within both the cardiovascular field and cancer. Our efforts to advance our development program through partnerships in these therapeutic fields will now continue at full speed!”

Solna August 23, 2024