In July 2020, Kancera initiated a phase II trial to evaluate efficacy, safety, tolerability and pharmacokinetics of KAND 567 in patients with SARS-COV-2 acute respiratory disease (KAN0006; EudraCT2020-002322-85). The open label trial intends to enroll 40 patients in Sweden. Patients will be administered with either oral KAND 567 as capsule in combination with the best standard treatment or only the best standard treatment. Earlier the Swedish Medical Products Agency had approved the clinical trial application (CTA) to conduct the phase II trial. Kancera had submitted an application to the Swedish Medicines Agency in May 2020 [2] [3] [4] .
In March 2020, Kancera released positive data from the final part of phase Ib trial and evaluated safety, tolerability in 17 healthy volunteers with 6 volunteers in placebo. A total of 92 healthy volunteers have been tested in phase I study [5] . In June 2019, Kancera initiated a phase Ib trial to evaluate the safety, tolerance and exposure of KAND 567 administered intravenously in 27 healthy volunteers in Sweden and Finald. The start of the trial triggered the third and final payment in the form of two million shares to Acturum, in mid-July, in accordance with the ongoing agreement between the two companies [6] [7] [8] . Earlier in May 2019, Medical Products Agency and the Ethics Committee had approved the application for the study. In August 2019, first exploratory part of the trial was completed and company announced positive interim results in healthy participants. The company also announced that a supplemental application would be filed to the Medical Products Agency, for the approval of an adjusted ratio of infusion rate to concentration of KAND 567. The protocol was amended to avoid local irritation at the infusion site, observed in the interim analysis [9] [10] [6] [11] . The company applied for permission by submitting a supplemental dosing strategy to Swedish Medical Products Agency to adjust ratio of infusion rate to concentration of KAND 567. The Swedish Medical Products Agency advised the company to submit supplementary information and a new application permit in order to continue the study. In February 2020, Kancera received approval from the Finnish Medicines Agency Fimea and the Ethics Committee to start the final part of the phase Ib program for KAND 567 [12] . Earlier in November 2019, Kancera reported that it had compiled the requested information and prepared a new application, but in order to maintain the timeline for a phase IIa trial the company had elected to apply for the final part of the study in Finland instead of as previously planned in Sweden. In December 2019, company released analysis of blood samples from healthy participants [13] [14] [6] [9] .
In February 2019, Kancera completed a phase Ia trial that evaluated the safety, tolerability and pharmacokinetic properties of KAND 567 in healthy volunteers. The randomised, double-blind, placebo-controlled trial was initiated in May 2017 and enrolled 82 healthy participants, in the Netherlands. First part of the study is single dose part of the study in which increasing single doses (8-2500 mg) of KAND 567 was given to groups of 62 healthy volunteers with and without food on different occasions. In the second part which is multiple dose part of the study, KAND 567 was given in increasing doses up to 7 days (300 - 800 mg twice a day). The second part of the study was commenced in September 2017 [15] [16] . In February 2018, Kancera announced positive results from this study. Results showed that KAND 567 blocks the fractalkine system by reducing the number of fractalkine receptors on the surface of immune cells. In February 2019, results from the 66 evaluable patients were released by the company [17] [18] [19] .
In June 2020, Kancera released preclinical data showing nerve-protective effect of KAND 567 in disease model of spinal cord injury [2] .
In January 2019, Kancera released safety data for the preclinical toxicological study of intravenous KAND 567 [11] .
In preclinical studies, KAND 567 exhibited an anti-inflammatory effect and protected blood vessels in atherosclerosis [20]
KAND 567 showed cardiovascular protection properties in preclinical disease models [19] . KAND 567 was evaluated for efficacy and safety in a disease model of myocardial infarction and in a toxicological GLP study, respectively. The efficacy study showed that lower doses than expected provided a significant cardio-protective effect. Preliminary results from the toxicology study provided evidence pointing towards the safety of the calculated effective dose of KAND 567 [21] .
Earlier, in April 2017, Kancera applied to the relevant authorities in the Netherlands for authorization for clinical trials. The Medical Ethics Committee (METC) at the University Medical Center in Groningen, the Netherlands, has given approval for the initiation of the phase I study (Kancera pipeline, December 2017).
According to the Kancera company website, as of August 2016, the company intends to apply for orphan drug designation for KAND 567.
In preclinical studies, KAND 567 counteracted the onset of autoimmune disorders, as well as neuritis and pain in connection with chemotherapy against cancer [1] .
Financing information
Kancera, in November 2019, received a bridge financing of approximately SEK 14.0 million. The company intends to use the proceeds from this financing for completing the phase Ib trial of KAND 567. The company expects to receive new issue units of approximately SEK 61.4 million during first quarter of 2020.The funds from this financing will be used to carry phase IIa trial [14]
