In connection with the upcoming Interim Report for the first quarter 2024, Kancera AB (publ) provides an operational update regarding KANDOVA, a combined phase Ib/IIa study of KAND567 in ovarian cancer, and reports that:

  • The patient recruitment pace has increased and in total 9 patients have completed one or more treatment cycles with KAND567
  • All five participating hospitals are fully operational
  • Part one of the study, phase Ib, is expected to be completed by mid-year

The implementation of the amended study protocol, with updated patient inclusion and exclusion criteria which received regulatory approvals during the first quarter this year, has as expected resulted in an increased number of patients that are meeting the enrollment criteria. In total 9 patients have been recruited to the first part of the study, phase Ib, which aims to define the recommended phase II dose, based on exposure and tolerability.

Phase Ib has an intra-patient dose escalation design, which includes up to four dose levels. The preliminary results support that the two initial dose levels are safe and tolerable and new patients are therefore receiving the second highest dose level as starting dose. All recruited patients have completed at least one treatment cycle with KAND567 and no dose limiting adverse events have been reported.

All five participating hospitals in Sweden, Norway and Denmark have recruited patients, who have completed one or more treatment cycles with KAND567. Based on the current status, the company expects that the phase Ib part of the study will be completed by mid-year 2024.

Kancera further announces that no new sites will be added to the second part of the study, phase IIa, as the company believes that the remaining part of the study most effectively can be conducted at the existing sites. The study protocol allows for up to 30 patients to be enrolled in the two parts of the study. The definite number of patients to be enrolled during phase IIa are continuously being assessed and will be ultimately decided during the second half of 2024, based on the study objectives.

About the KANDOVA study
KANDOV is a one-arm, open-label, multi-centre, combined phase Ib/IIa study of Kancera’s candidate drug KAND567 in combination with carboplatin therapy in ovarian cancer patients with relapse from carboplatin therapy. The study is conducted at five university hospitals in Sweden, Norway and Denmark in collaboration with the clinical trials unit of the Nordic Society of Gynaecological Oncology (NSGO-CTU), a society of leading academic hospitals and gynaecological clinicians in the Nordic countries.

In the study, KAND567 is given during two weeks in connection with each infusion of carboplatin, which takes place every third week. The first part of the KANDOVA study, phase Ib, has an intra-patient dose escalation design, which includes up to four dose levels: 250 mg, 375 mg, 500 mg and 625 mg, given twice daily during the first week. During the second week, 250 mg is given twice daily. The objective of phase Ib is to define the recommended phase II dose.

The primary objective of the study is to evaluate safety and tolerability. The secondary objective is to evaluate signals of KAND567’s anti-tumor effect, when administered in combination with carboplatin, and in addition a wide range of exploratory endpoints are being studied.

About Kancera AB (publ)
Kancera is developing a new class of small molecule drugs targeting the fractalkine axis. Kancera’s main focus is to develop its candidate drugs for treatment of severe inflammatory diseases and cancer that currently lack effective treatments. The stock is traded on the Nasdaq First North Premier Growth Market. FNCA Sweden AB is the company's Certified Adviser.

For further information:
Visit Kancera’s website: www.kancera.com

or contact:
ir@kancera.com or phone: +46 (0)8-5012 60 80

Attachments

PR EN KANDOVA Update 240516

© Modular Finance, source Nordic Press Releases