Phase Ib completed and the recommended phase II dose is set in the ongoing KANDOVA study


Kancera AB (publ) today reports that the first part, phase Ib, has been successfully completed in the ongoing KANDOVA study, a combined phase Ib/IIa study of Kancera’s candidate drug KAND567 in ovarian cancer in combination with carboplatin. The objective of part one, to define the recommended phase II dose, was met and phase IIa is now starting.

The increased enrollment pace in the KANDOVA study has been maintained and I am very glad that we now have an established phase II dose with a favorable safety profile for KAND567 in ovarian cancer and that we now are moving forward to phase IIa,” says Peter Selin, CEO at Kancera.

The phase Ib study has had an intra-patient dose escalation design aiming to define the recommended phaser II dose. Based on the results, the company has set the recommended dose to 375 mg*. The primary rationale for the selected dose is that the targeted exposure, i.e. the concentration of KAND567 in the plasma, is obtained at this dose, in combination with a favourable safety profile. Higher doses are associated with an increased risk of side effects without an expected improved efficacy.

The company further reports that 11 patients in total have now been enrolled in the KANDOVA study and that part two of the study, phase IIa, is now starting.

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 had an intra-patient dose escalation design, which has included 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 has been 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.

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