Kancera provides operational update for its Fractalkine-blocking drug candidates KAND567 and KAND145
Kancera AB (publ) today reports that the clinical studies of its Fractalkine-blocking drug candidates KAND567 and KAND145 are progressing according to plans and that the US patent office has issued a patent that protects the manufacturing processes.
Kancera AB today reports that the US patent office (USPTO) has issued a patent that protects the manufacturing processes for KAND567 and KAND145. The patent, 11,542,281, is owned by Kancera and is valid until 2039.
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.
The company further reports that applications to conduct the KANDOVA-study have now been submitted to the regulatory authorities in all countries where the study will be conducted, i.e. Sweden, Denmark and Norway. The KANDOVA-study is a combined phase Ib/IIa study of KAND567 in ovarian cancer patients that is conducted in collaboration with the Nordic Society of Gynaecological Oncology and its clinical trial unit (NSGO-CTU). NSGO-CTU is a society among the leading University hospitals and gynaecological clinicians in the Nordic countries.
Given a positive outcome of the KANDOVA-study, Kancera is planning to continue drug development within cancer based on its second-generation drug candidate KAND145. KAND145 has certain product characteristics which make it more suitable for treatment of solid tumors compared to KAND567. The advantage of starting the clinical development in ovarian cancer with KAND567 is that clinical studies can be initiated earlier. The preparations for starting clinical development of KAND145 are on track and a phase Ia study in healthy volunteers is planned to start in Q2 2023.
”We are happy that all our clinical studies are on track and that we are taking important steps towards our long term strategic objective to enter into commercially attractive partnerships. It’s also encouraging that we are delivering in line with our IP strategy and continuously strengthen the product protection of our Fractalkine program.”, says Thomas Olin, CEO at Kancera.
About the FRACTAL-study
The FRACTAL-study is a phase IIa clinical study of KAND567 in myocardial infarction patients undergoing percutaneous coronary intervention. The study is conducted in collaboration with the British NHS Foundation which is the sponsor of the study. The FRACTAL-study is conducted at the Freeman Hospital in Newcastle and James Cook Hospital in Middlesbrough. 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 reduce myocardial damage following infarction and thereby reduce risk for severe complications, heart failure and increase survival.
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 will be conducted at university hospitals in Stockholm, Lund, Copenhagen, Odense and Oslo. 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 use Kancera's fractalkine-blocking drugs to restore the effect of cytostatics and thereby increase survival.
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. The stock is traded on the Nasdaq First North Premier Growth Market.
For further information:
Chief Executive Officer, Kancera AB
Tel: +46-73-620 40 01
Visit Kancera’s web page: https://www.kancera.com/en