Preparation for a clinical study with KAND567 in COVID-19 patients now under way
Kancera AB (Nasdaq First North Premier Growth Market: KAN) today announces that independent researchers have published results showing that the fraktalkine system is activated in Covid-19 patients and that increased levels of fractalkine are accompanying more severe disease. A placebo-controlled, clinical study investigating the company's drug candidate KAND567 in COVID-19 patients has now been approved by the Swedish Medical Products Agency and is scheduled to commence soon after approval from the Ethical Review Board.

Kancera's drug candidate KAND567 works by blocking the Fractalkine receptor which plays a key role when the body's immune system initiates the inflammatory process. Blocking the fractalkine receptor prevents certain types of immune cells from accumulating in various tissues which can reduce the damage caused by hyperinflammation.

In the ongoing COVID-19 pandemic, hyperinflammation is a condition that can affect severely ill patients in situations when the immune system has failed to fight the virus initially. The immune system is then at risk of being out of balance and overreacting through a second wave of inflammation – hyperinflammation – which can lead to serious damage to the lung, heart and other vital organs1.

An independant research team has now published results showing that COVID-19 patients show an elevated concentration of fractalkine in blood compared to healthy controls and that a high concentration of fractalkine in the blood is observed in patients suffering from a more severe disease condition2.. By monitoring the flow of immune cells in the blood of COVID-19 patients, researchers have shown that fraktalkine carry activated immune cells into vital organs such as the lungs, heart and vessels. In-depth analysis have confirmed infiltration of immune cells  known to be controlled by the fraktalkine system in the lungs of COVID-19 patients3. The studies have been conducted in COVID-19 patients starting when they were admitted to hospital with mild breathing problems, in intensive care and through rehabilitation3,4.

Overall, the results support a treatment strategy whereby the immune cells driving the disease are blocked in an early phase of COVID-19 thereby reducing the risk of hyperinflammation, intensive care treatment and a lengthy rehabilitation.

Kancera's planned double-blinded and placebo-controlled Phase II study in COVID-19 patients   takes note of these new results. KAND567 or placebo will be combined with the best standard treatment already in the early phase of the disease when early breathing difficulties are  observed. During the study, strictly objective analyses of the treatment effect will be performed, including analysing oxygen saturation and respiratory capacity. In addition, a detailed mapping of immunologic regulation at the cellular and gene levels will be carried out.

The study is planned to comprise 40 patients, half of whom will be treated with KAND567 and the other half being the placebo group. Treatment with KAND567 will be done orally in the form of capsules twice a day for seven days. A follow-up health check and sampling will take  place after completion of treatment and after 90 days in order to follow the rehabilitation.

References

1     The Lung, the Heart, the Novel Coronavirus, and the Renin-Angiotensin System; The Need for Clinical Trials. https://doi.org/10.3389/fmed.2020.00248

2     Elevated Serum Endothelial Cell Adhesion Molecules Expression in COVID-19 Patients.

The Journal of Infectious Diseases, jiaa349.  https://doi.org/10.1093/infdis/jiaa349

3  Single-cell landscape of bronchoalveolar immune cells in patients with COVID-19.  https://doi.org/10.1038/s41591-020-0901-9

4    Systems-level immunomonitoring from acute to recovery phase of severe COVID-19.  https://doi.org/10.1101/2020.06.03.20121582

About Kancera AB (publ)

Kancera develops drugs that counteract damage from acute and chronic inflammation. Fraktalkine blocker KAND567 is developed primarily to effectively counteract hyperinflammation in various medical conditions and thus protect vital organs, e.g. in connection with heart attacks and severe viral infections. In the second quarter of 2020, Kancera applied for a permit for a phase II clinical study in covid-19 patients. In the second half of 2020, a second application for authorisation is planned for a phase II clinical study in patients with myocardial infarction. Since scientific studies have shown increased activity for the fractalkine system not only in connection with myocardial infarction but also in several other inflammatory conditions and certain forms of cancer, there are several possible development routes for Kancera’s fraktalkine blockers KAND567 and KAND145. Kancera AB conducts research and development within Karolinska Institutet Science Park in Stockholm. The share is traded on NASDAQ First North Premier. FNCA Sweden AB is the company's Certified Adviser. FNCA can be reached on info@fnca.se and on 08-528 00 399. 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.

For further information, please contact,

Thomas Olin, CEO: +46-735-20 40 41
Kancera AB (publ)
Karolinska Institutet Science Park Banvaktsvägen 22
SE 171 48 Solna

Please visit the company's website; https://www.kancera.com