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Vecabrutinib (SNS-062):

An Oral BTK Kinase Inhibitor

SNS-062 is a potent, reversible, non-covalent inhibitor of Bruton's tyrosine kinase (BTK). This target mediates B-cell receptor (BCR) signaling and is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. BTK has been well validated as a target for treatment of B-cell malignancies, with a BTK inhibitor approved for relapsed/refractory mantle cell lymphoma, relapsed/refractory chronic lymphocytic leukemia, or CLL, CLL with 17p depletion and Waldenström's macroglobulinemia among other indications. SNS-062 does not interact with the cysteine residue, C481, within the kinase domain that is required by other approved and emerging covalent BTK inhibitors. Because SNS-062 is a selective, non-covalent inhibitor with a favorable pharmacokinetic profile, SNS-062 may provide differentiated opportunities for treatment of B-cell malignancies and other cancers.

SNS-062 has been evaluated in nonclinical safety pharmacology studies and in GLP toxicology studies in rats and dogs. Oral administration of SNS-062 was tested across dose levels of 25, 50, 100, 200, and 300 mg in healthy subjects in a Phase 1a, single-dose, double-blind, placebo-controlled, dose-ranging, food-effect, and drug-drug interaction clinical trial (EudraCT 2016-000180-16). The drug was well tolerated at all dose levels. Pharmacokinetic and pharmacodynamic (inhibition of phosphorylated BTK) data indicated that SNS-062 achieved plasma levels that would support twice-daily dosing in patients.

Collectively, these nonclinical and clinical data provided a foundation for initiation of Phase 1b/2 clinical development of SNS-062 in patients with B-lymphoid malignancies. The ongoing Phase 1b/2 trial is an open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of SNS-062 (NCT03037645).

The rights to develop and commercialize SNS-062 for oncology indications were in- licensed from Biogen Idec in December 2013.

Clinical Trials

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Presentations

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Vecabrutinib (SNS-062) Presentations

Publications

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Vecabrutinib (SNS-062) Publications