Karus Therapeutics, a company into the development of orally active medicines with breakthrough potential in the treatment of cancer, has announced that the first patients have been dosed in a Phase I study for its lead candidate, KA2237.
This is the firm’s first product to enter clinical trials.
KA2237 is a dual-selective inhibitor of two PI3K isoforms, p110β and p110δ.
Inhibiting these two isoforms combines an immunotherapeutic response and a direct impact on tumour growth through selective targeting of the PI3K pathway.
Karus noted that KA2237 has wide therapeutic applicability in the treatment of hematological and solid tumours, either as a single agent or in addition to other drugs.
This trial is part of the pre-clinical and clinical collaboration between Karus and the University of Texas MD Anderson Cancer Center.
The first aspect of the trial has been intended to analyse the safety of KA2237 alone in relapsed, treatment-resistant, B-cell lymphoma patients.
An expansion cohort study will follow and is slated to begin in 2017.
Karus expects that up to 40 patients will be treated over the complete study.
Karus Therapeutics CEO Dr Simon Kerry said: “Our first clinical trial is a major milestone for the company. Karus has made exceptional progress and our collaboration with MD Anderson will help us to accelerate this clinical programme.
“We believe that as an orally active dual p110β/δ inhibitor, KA2237 has significant potential in the treatment of hematological and solid tumours in areas of high, unmet medical need.”
The agreement with MD Anderson includes several pre-clinical studies of Karus’ two cancer programmes, KA2237 and KA2507.
Its focus is on identifying optimal drug combinations and the right patient populations for further clinical development.
The second programme of KA2507 is a selective-HDAC6 inhibitor and has both a targeted therapy and immunotherapeutic action with potential to treat multiple myeloma, B-cell and T-cell lymphomas and PD-L1 expressing hematological and solid tumours.