Rugocrixan is a small-molecule antagonist of the Fractalkine receptor CX3CR1, being developed by Kancera, under an agreement with Acturum Life Science and in collaboration with Uppsala University, for the treatment of myocardial infarction, SARS-COV-2 acute respiratory disease, cardiovascular inflammation, peritoneal cancer., fallopian tube cancer, ovarian cancer and spinal cord injuries. Fractalkine is an immune-modulating factor, which transmits signals via the CX3CR1 receptor, thereby controlling the function of immune cells and cancer cells. Clinical development is underway in several countries. Preclinical development is underway in Sweden, for spinal cord injuries.

No recent reports of development have been identified for cancer pain, breast cancer, and autoimmune disorders. Development for the treatment of multiple myeloma has been discontinued.

AstraZeneca originally developed KAND 567 against multiple sclerosis. Acturum Life Science later acquired the rights to the project from AstraZeneca.

As at March 2021, no recent reports of development had been identified for preclinical development in Ovarian-cancer in Sweden (PO). As at April 2023, no recent reports of development had been identified for phase-I development in Myocardial-infarction (In volunteers) in Sweden (IV, Infusion), Finland (IV, Infusion), preclinical development in Cardiovascular-disorders in Sweden (PO), preclinical development in Ovarian-cancer in Sweden (PO). As at February 2024, no recent reports of development had been identified for phase-I development in Myocardial-infarction in Finland (PO, Capsule).

As at July 2024, no recent reports of development had been identified for preclinical development in Spinal-cord-injuries in Sweden.

In February 2021, Kancera entered into a collaboration with SciLifeLab, which gives Kancera the opportunity to identify new starting points for drug development as needed. Kancera announced that the company is collaborating with SciLifeLab in a research study of patients with COVID-19 who have suffered from long-term symptoms. The purpose of the study is to map how the immune system affects these patients, which is expected to contribute to the development of new treatments. ^[1]

In September 2017, Kancera entered into a development and manufacturing agreement with Recipharm, for the manufacture of KAND 567. As part of the collaboration, Recipharm will develop the preparation that is required for effective release of KAND 567 from the capsules, as well as manufacturing the pharmaceutical product. The work is intended to be performed at Recipharm’s development facility in Solna ^[2]

According to the Kancera first quarter of 2016 report, Kancera entered into an agreement with Acturum Life Science AB to evaluate and further develop KAND 567, in 2015. Under the agreement, Kancera has the right to evaluate KAND 567 in preclinical studies and then to acquire the project. The agreement entails no expenses for Kancera apart from investments in the patent portfolio and in the scientific evaluation. Kancera announced that it has chosen to acquire the project. If the acquisition goes through, following preclinical studies phase, the total payment to Acturum will consist of 6 million Kancera shares divided into three tranches, which are due at pre-defined success-milestones. Both companies will share the risk in product development through the first study in man.

Acturum Life Science acquired the rights to the KAND 567 project from AstraZeneca as part of Acturum’s acquisition of the research facility in Södertälje. However, AstraZeneca has retained the rights to develop Fractalkine inhibitors against respiratory diseases.

In June 2025, Kancera completed a successful pre-IND meeting with the US FDA and received positive feedback on the planned clinical development program for KAND567 in ST-elevation myocardial infarction. The FDA states that it agrees the proposed clinical development plan could support a marketing application and be eligible for Fast Track Designation. The proposed clinical development plan includes a phase IIb FRACTIVE trial to evaluate the cardio protective effects after intravenous and oral administration of KAND567 in patients with anterior STEMI undergoing primary percutaneous coronary intervention. Other preclinical and clinical development activities required prior to conducting pivotal studies and a pivotal phase III study to further evaluate the safety of KAND 567 as well as effect on major cardiovascular outcomes ^[3] .

As of May 2025, Kancera has submitted a pre-IND application with the US FDA with the objective to receive formal feedback on the planned phase IIb study design and the overall clinical development plan up until market approval. The company expects to present the FDA feedback before the end of the second quarter 2025 ^[4] .

In March 2025, Kancera announced its intention to initiate a phase IIb trial of KAND 567 for the treatment of Myocardial infarction in 2026 ^[5] .

In February 2024, Kancera announced it's intention to initiate a phase IIb/III registrational trial in cardiovascular diseases ^[6] .

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 ^{[7] [8] [9] [10] [11]} . 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 ^[12] .

In July 2023, Kancera announced that the trial met primary and secondary endpoints and completed the phase IIa FRACTAL trial that evaluated 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 (EudraCT2021-001354-53; ISRCTN18402242; 21NW0178; IRAS1003810; Sponsor-ID09603). The double-blind, parallel, randomised trial was initiated in January 2021 and enrolled 60 patients in the UK. In February 2022, Kancera announced that the trial reached the primary objective of the study ^[13] . In December 2022, Kancera announced that a decision has been made to enable the recruitment of an additional 10 patients to the FRACTAL study ^{[14] [15] [7] [16]} . In March 2023, company completed the enrollment of 71 patients in the trial ^[17] . In December 2023, Kancera released topline data from the FRACTAL study ^{[6] [18]} . In August 2024, company presented efficacy and adverse event data from the trial at Annual Congress of the European Society of Cardiology 2024 (ESC-Card-2024) ^[19] .

In June 2025, Kancera reported that the primary study objective to determined the recommended dose and evaluate safety and tolerability was met. Additionally, the secondary study objective was also met ^[20] . In April 2025, Kancera completed the phase Ib/IIa KANDOVA-study in patients with ovarian cancer (EudraCT2022-002792-11; NCT06087289; KAN0007). This open-label, multicenter dose escalation study that evaluated the safety and tolerability of KAND 567, in combination with carboplatin therapy, and determined the Recommended Phase II Dose (RPIID) of KAND 567 with an expansion cohort in women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and enroled 18 patients in Norway and Sweden and Denmark and the last patient has conducted the last visit ^{[21] [4]} . In February 2023, the Swedish Medical Products Agency approved a clinical trial application for the phase Ib/IIa KANDOVA-study in patients with ovarian cancer. Earlier, in December 2022, Kancera submitted a regulatory application for clinical trial of KAND 567 to the Swedish Medical Products Agency in ovarian cancer. Previously, Kancera reported that clinical trial applications to the Danish and Norwegian regulatory agencies had been submitted and expects to receive clearance by March 2023 ^{[15] [22]} . In June 2023, Kancera reported that the first patient has been dosed in the trial ^[23] . In July 2024, the phase Ib portion of the trial was completed and the phase II portion was initiated ^[24] . In April 2025, Kancera announced that the last patient completed the last visit in the trial ^[25] . In June 2025, the company released efficacy and adverse events data from the trial ^[20] .

A capsule formulation of KAND 567 has been evaluated in a phase I study in Finland ^[26] .

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 ^[27] . 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 ^{[28] [29] [30]} . 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 ^{[31] [32] [28] [33]} . 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 ^[34] . 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 ^{[35] [36] [28] [31]} .

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 ^[7] .

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 ^{[37] [38]} . 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 ^{[39] [40] [41]} .

In December 2022, Kancera in collaboration with Nordic Society of Gynaecological Oncology plans a phase Ib/IIa trial of KAND 567 in combination with platinum therapy in ovarian cancer patients with relapsed disease. The trial is intended in Sweden, Denmark and Norway ^[22] .

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 ^[8] .

In June 2020, Kancera released preclinical data showing nerve-protective effect of KAND 567 in disease model of spinal cord injury ^[9] .

In January 2019, Kancera released safety data for the preclinical toxicological study of intravenous KAND 567 ^[33] .

In preclinical studies, KAND 567 exhibited an anti-inflammatory effect and protected blood vessels in atherosclerosis ^[42]

KAND 567 showed cardiovascular protection properties in preclinical disease models ^[41] . 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 ^[43] .

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

As of December 2022, Kancera completed rights issue ensures financing of the KANDOVA study - clinical development against ovarian cancer ^[14] .

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 ^[36]

In August 2023, Kancera reported that the US patent office (USPTO) has issued a patent that protects the manufacturing processes for KAND567. This patent (US 116 919 88) enables Kancera to apply for data exclusivity and market protection for up to 7.5 years for the first indication approved in the United States ^[44] .

In March 2023, the Japan patent office granted a patent to Kancera, that protects the manufacturing processes for KAND 567 and KAND 145 [See AdisInsight drug profile 800052463]. The patent, JP7 225 379, is owned by Kancera and is valid until 2039 ^[45] .

In January 2023, Kancera reported that the US patent office (USPTO) has issued a patent that protects the manufacturing processes for KAND567. The patent, 11,542,281, is owned by Kancera and is valid until 2039 ^[46] .

In August 2019, Kancera reported that two patent applications related to KAND 567, entered the international phase, at the conclusion of the second quarter of 2019. The patent applications were filed earlier in July 2018, as reported by Kancera ^{[28] [47]} . Patents contains use of KAND 567 for the treatment and prevention of hyperinflammation in viral infections ^[10] .