Sunesis Pharmaceuticals has started dosing patients in a Phase Ib/II clinical trial of SNS-062 to treat patients with B-cell malignancies such as chronic lymphocytic leukaemia (CLL), small lymphocytic leukaemia, Waldenstrom’s macroglobulinemia and mantle cell lymphoma.

SNS-062 is an oral, selective, reversible, non-covalent inhibitor of Bruton's tyrosine kinase (BTK) being developed to retain activity in the presence of a C481S mutation occurring in BTK’s kinase domain.

The open-label, sequential-group Phase Ib/II trial will assess SNS-062 in 124 adults who have relapsed or progressed advanced B-cell malignancies following prior therapy.

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To be performed at five US centres, the trial will include a dose escalation part and a cohort expansion part.

Sunesis CEO Daniel Swisher said: “This study is designed to provide initial proof-of-concept that SNS-062 can become a new treatment option for patients with relapsed CLL.

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"This study is designed to provide initial proof-of-concept that SNS-062 can become a new treatment option for patients with relapsed CLL."

“We look forward to progress this trial to identify a recommended dose and to characterise the profile of SNS-062 across a range of B-cell malignancies.”

The Phase Ib dose escalation part will investigate the safety, pharmacokinetics, pharmacodynamics and anti-tumour activity of various SNS-062 dose levels to establish a maximum tolerated and / or recommended dose. 

SNS-062’s clinical activity and safety as a monotherapy will be further evaluated in the Phase II cohort expansion part of the trial within specific disease cohorts.

The drug is reported to have improved pharmacokinetics and sustained BTK inhibition during a randomised, double-blind, placebo-controlled, single ascending dose Phase Ia trial when compared to ibrutinib.