Kancera reports in-depth analysis of the Phase Ib program with KAND567, showing the desired effect on the human immune system

Kancera AB (Nasdaq First North Growth Market: KAN) reports results from an in-depth immunological analysis of blood samples from healthy subjects in the ongoing Phase Ib program. The analysis shows that KAND567 effectively blocks certain specific immune cells that are known to cause acute and chronic inflammatory diseases. This is the first time this effect has been shown on clinically relevant biomarkers and the results provide further support for the potential cardiovascular protective effect of KAND567.

In the case of an acute myocardial infarction, only about 50 percent of the damage to the heart occurs during the first acute oxygen deficiency, the remainder occurs after the patient is treated with life-saving balloon dilation of the vessels. The reason is that the initial heart injury attracts activated inflammatory cells as the blood flows returns to the vessel. The result is an exaggerated immunological reaction that further affects the heart. The damage caused by the immune activation increases the risk of complications or additional heart attacks.

The immunological reaction that occurs in myocardial infarction is due to a powerful activation of the Fractalkine system, which in turn is linked to a higher risk of death within three years after the infarction. Kancera’s candidate drug KAND567 blocks the Fractalkine system and is expected to protect the heart. The ongoing Phase Ib program is investigating tolerability and dosing of intravenously administered KAND567 in preparation for a planned Phase IIa study in patients suffering from acute myocardial infarction.

An in-depth immunological analysis of blood samples from healthy subjects included in the Phase Ib program now shows for the first time that KAND567 has the desired effect on the human immune system. The fact that KAND567 blocks the Fractalkine system in humans has been shown in previous studies, but data have so far been lacking to prove that blocking causes the immunological processes that damage the heart. The analysis carried out now shows that the subjects who have received KAND567 have lowered levels of an established and clinically relevant immune marker. The effect on the immune marker proves that the blockage of the Fractalkine system leads to a significant decrease in activity of two types of immune cells, both of which are known to cause inflammatory diseases; monocytes/ macrophages and NK cells (natural killer cells). Full effect was seen at the first measurement point two hours after infusion.

In addition to proving that KAND567 has the desired effect on the immune system, the results mean that KAND567 and KAND145 (which act by the same mechanism as KAND567) have the potential to achieve significant protective effects in both cardiovascular and other acute and chronic diseases, including inflammatory niche diseases and cancer.

Kancera is now preparing the final stage of the Phase Ib program in healthy subjects conducted to study the safety and tolerability of intravenous infusion of KAND567, as well as to generate information on the optimal infusion rate required to rapidly reach the active blood concentration in the planned Phase IIa study in cardiac patients.

” The new results provide convincing support that KAND567 and KAND145 have the potential to help patients with severe inflammatory conditions. We already know that the calculated effective dose of KAND567 reaches the heart within five minutes of infusion. All in all, the conditions for a successful phase IIa study in heart patients have been further strengthened, and thus also the conditions for our drug candidate to become a unique and effective treatment that saves lives,” says Thomas Olin, CEO of Kancera.

About Kancera
Kancera develops drugs that counteract damage during acute and chronic inflammation. The Fractalkine blocker KAND567 is primarily developed to effectively and selectively reduce the inflammation of the heart and vessels following a heart attack and is expected to enter the clinical phase II study during the first half of 2020. Since scientific studies have shown elevated levels of fractalkine not only in heart attacks but also in inflammatory diseases and certain forms of cancer, there are several possible development opportunities for the fractalkine blockers KAND567 and KAND145. Kancera also develops preclinical drug projects against cancer aimed at stopping survival signals in the cancer cell and preventing the cancer cell's ability to be repaired. Kancera operates at Karolinska Institutet Science Park in Stockholm. The share is traded on Nasdaq First North. FNCA Sweden AB (tel. 08-528 00 399, info@fnca.se) is the company's Certified Adviser. MD PhD Charlotte Edenius, MD PhD Anders Gabrielsen, Professor Carl-Henrik Heldin and Professor Håkan Mellstedt are all scientific advisors and board members of Kancera AB.