In July 2021, Kancera completed a phase II trial that evaluated 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 was initiated in July 2020 and enrolled 40 patients in Denmark. The trial prematurely ended 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. As at April 2021, two third patients were dosed in the trial. In February 2022, Kancera announced that the results obtained from the trial indicated favourable safety and "proof of principle" for the desired pharmacological effect on inflammatory cells [3] [4] [5] [6] [7] . In June 2021, company completed patient recruitment for the COVID-19 study after just over 80%of the originally planned number of COVID-19 patients have received their dose. The decision was made in light of the fact that the number of cases in need of hospital care has decreased significantly and the current patient base was considered sufficient to provide important and relevant results [8] .
In February 2022, Kancera announced that the trial reached the primary objective of the study. In November 2021, Kancera had initiated a phase IIa FRACTAL trial to evaluate the safety, tolerability, anti-inflammatory and cardio-protective effects after intravenous and oral administration of KAND 567 in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (EudraCT 2021-001354-53; ISRCTN 18402242; 21NW0178; IRAS1003810Sponsor-ID09603). The double-blind, parallel, randomized trial intends to enrol 60 patients in the UK and England. In February 2022, the company reported that the results obtained from the trial indicated the chosen dosage resulted in a desired concentration of KAND 567 in the blood and that this dose was well tolerated. A pharmacological effect on the immune system was reported [3] [9] .
A capsule formulation of KAND 567 has been evaluated in a phase I study in Finland [10] .
In February 2021. Kancera completed a phase Ib trial that evaluated the safety, tolerance and exposure of KAND 567 administered intravenously in 27 healthy volunteers in Sweden and Finland. The double blind trial tria was initiated in June 2019. 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 [11] . 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 [12] [13] [14] . 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 [15] [16] [12] [17] . 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 [18] . 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 [19] [20] [12] [15] .
In February 2022, Kancera announced its plans to initiate a phase Ib trial that will evaluate the tolerability of KAND 567 in combination with chemotherapy and the effect on markers that reflect the treatment's effect on the cancer disease [3] .
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 [21] [22] . 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 [23] [24] [25] .
In April 2021, Kancera released preclinical results which showed that KAND 567 was effective in ovarian cancer which were refractory to chemotherapy, through inhibition of DNA repair [4] .
In June 2020, Kancera released preclinical data showing nerve-protective effect of KAND 567 in disease model of spinal cord injury [5] .
In January 2019, Kancera released safety data for the preclinical toxicological study of intravenous KAND 567 [17] .
In preclinical studies, KAND 567 exhibited an anti-inflammatory effect and protected blood vessels in atherosclerosis [26]
KAND 567 showed cardiovascular protection properties in preclinical disease models [25] . 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 [27] .
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 [2] .
Financing information
In February 2021, Kancera announced that the conversion of TO4 during 2020 provided Kancera with a total of approximately SEK 38.6 million, which may be utilised for an accelerated development of the company's drug projects aimed at COVID-19 and myocardial infarction, including the drug candidates KAND 567 and KAND 145 [see AdisInsight drug profile800052463] [1] .
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 [20]
