Kancera reports that the Swedish Medical Products Agency has approved the application to conduct the KANDOVA-study and that Dr. Hanjing Xie has been appointed to Chief Medical Officer

Kancera today reports that the Swedish Medical Products Agency has approved the application to conduct a clinical study of Kancera’s Fractalkine blocker KAND567 in ovarian cancer patients, the so called KANDOVA-study. The aim of the study is to evaluate KAND567’s ability to restore sensitivity for platinum-based chemotherapy in ovarian cancer patients with relapse. Kancera is currently making the final preparations to start the study in Sweden, where the study is planned to be conducted at two University hospitals. Kancera has previously reported that applications to the Danish and Norwegian regulatory agencies have been submitted and expects to receive final decisions during March.

Kancera further announces that Dr. Hanjing Xie has been appointed as new Chief Medical Officer, CMO. Dr. Xie has more than 25 years of combined experience from research and clinical development and as physician. Dr. Xie has experience from both the pharmaceutical industry, at companies such as Idogen, Oncopeptides and Bayer, and from university hospitals and institutes, such as the Karolinska University Hospital, the Karolinska Institute and St. Göran’s hospital. Dr. Xie is associate professor and senior consultant in oncology, holds a Ph.D. in clinical pharmacology and board certifications in clinical oncology, internal medicine and hematology. As CMO, Dr. Hanjing Xie will be overall medically responsible at Kancera. Near term, she will focus on the KANDOVA-study and the continued development of Kancera’s Fractalkine blocking drug candidates for treatment of solid tumors.

Dr. Hanjing Xie will initially take on a part time assignment and Kancera’s previous CMO, Dr. Torbjörn Lundström, will remain as advisor, primarily focusing on the completion of the FRACTAL-study. All together, this will strengthen Kancera’s medical expertise.

In addition, Kancera is making other changes to adapt the organization to the new scope of business and clinical pipeline priorities. As a consequence of these changes, some employees will transition to work as subject matter experts on consulting basis, in order to meet the fluctuating needs in a more cost efficient way.

Kancera also reports that the patient enrollment to the ongoing FRACTAL-study, a phase IIa study of KAND567 in myocardial infarction patients undergoing percutaneous coronary intervention, is progressing well and 66 patients in total have been recruited as of today. This exceeds the initial objective of 60 patients in total. As has been previously announced, an amendment to the study protocol was filed to allow for recruitment of up to 70 patients in total, in order to increase the number of evaluable subjects in the study. Patient enrollment will continue to end of February at the latest and the objective is to report top line results during the third quarter this year.

”We are very happy about the recruitment of Hanjing Xie. Her deep and broad expertise within both oncology and immunology will contribute to strengthening our ability to develop new drugs for treatment of cancer and severe inflammatory diseases. I also would like to express our gratitude to Torbjörn Lundström for his valuable contributions in making Kancera a leading company in the field of developing drug candidates based on the Fractalkine system.”, says Thomas Olin, CEO at Kancera.

About the KANDOVA-study
The KANDOVA-study is a combined phase Ib/IIa study of KAND567 in combination with carboplatin therapy in ovarian cancer patients with relapsed disease. The study is conducted in collaboration with the clinical trials unit of Nordic Society of Gynaecological Oncology (NSGO-CTU) and is planned to be conducted at five university hospitals in Sweden, Denmark and Norway. The primary objective is to evaluate safety and tolerability. The secondary objective is to evaluate evidence of KAND567’s treatment efficacy. The long-term objective is to restore sensitivity to platinum treatment and thereby prolong survival. Top line results are expected to be reported during H2 2024.

About the FRACTAL-study
The FRACTAL-study is a phase IIa clinical study of KAND567 in myocardial infarction patients undergoing percutaneous coronary intervention. The primary objective is to evaluate safety and tolerability. The secondary objective is to evaluate evidence of KAND567’s treatment efficacy. Top line results are planned to be reported during Q3 2023.

About Kancera AB (publ)
Kancera is developing a new class of drugs for treatment of cancer and severe inflammatory diseases. Kancera’s main focus is to develop small molecule drug candidates based on the Fractalkine system. Fractalkine is a natural master regulator that with precision controls immune cells and cancer cells. During 2023 Kancera will finalize the FRACTAL-study, aiming to prolong survival for patients undergoing percutaneous coronary intervention, and initiate the KANDOVA-study, aiming to restore sensitivity to platinum treatment and thereby prolong survival. The stock is traded on the Nasdaq First North Premier Growth Market.

For further information:
Thomas Olin
Chief Executive Officer, Kancera AB
Tel: +46-73-620 40 01

Visit Kancera’s web page: https://www.kancera.com/en