On June 13, 2022 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for unmet needs in cancer, reported the initiation of patient dosing in TWT-203, its Phase 1b/2 study to evaluate CFI-402257, an oral, best-in-class inhibitor of Threonine Tyrosine Kinase (TTK, also known as MPS1) in patients with advanced solid tumors and ER+/Her2- breast cancer (Press release, Treadwell Therapeutics, JUN 13, 2022, View Source [SID1234615933]). Dosing of the first patient in the trial commenced June 8th at START Mountain Region in Salt Lake City, Utah.
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"Inhibition of TTK, a key mitotic checkpoint, with CFI-402257 represents a novel treatment approach for ER+/Her2-breast cancer, particularly in the context of CDK4/6 inhibitor failure" said Principal Investigator, Dr. Justin A. Call, MD, Director of Clinical Research at START Mountain Region in Salt Lake City, Utah.
"We are excited about the initiation of TWT-203 with our potent and selective TTK inhibitor," said Dr. Michael Tusche, Treadwell co-CEO. "Previous clinical studies have demonstrated that CFI-402257 has a tolerable safety profile and confirmed responses in ER+/Her2- breast cancer after progression on CDK4/6 inhibitors. We look forward to the continued development of this molecule in breast cancer."
The Phase 1b/2 clinical trial of CFI-402257 is an open-label, multi-center, dose optimization study designed to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CFI-402257 as a single agent in advanced solid tumors or in combination with fulvestrant in ER+/Her2- Breast Cancer patients after disease progression on prior CDK4/6 inhibitor and endocrine therapy. The trial will enroll approximately 40 patients at up to 10 sites in the United States. It will include a dose confirming portion in advanced solid tumors and expansions at the Recommended Phase 2 dose as a monotherapy in solid tumors and in combination with fulvestrant in breast cancer patients.