On December 9, 2022 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers, reported data presented on the ongoing CFI-402257-CL-001 clinical study of the Company’s CFI-402257 program in advanced solid tumors, continued to show a tolerable safety profile and demonstrated clinical benefit both as a monotherapy as well in combination with fulvestrant. Data were presented at the 2022 San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Treadwell Therapeutics, DEC 9, 2022, View Source [SID1234626020]).

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"CFI-402257 is well-tolerated and showed signs of anti-tumor activity either as a monotherapy or in combination with Fulvestrant, including some patients who were with durable disease control after progression on prior CDK4/6 inhibitor therapy" said Dr. Philippe Bedard, Study investigator and Associate Professor of Medicine at the University of Toronto and Staff Medical Oncologist at the Princess Margaret Cancer Centre, Toronto, Canada.

"CFI-402257 continues to demonstrate an encouraging clinical profile, and we look forward to further developing the molecule for the treatment of ER+ breast cancer," added Dr. Michael Tusche, Treadwell co-CEO.

2022 SABCS Poster Presentations and Details:

An Update to a Phase I Trial of CFI-402257, an oral TTK Inhibitor, in Patients with Advanced Solid Tumors with HER2-Negative Breast Cancer Expansion Cohorts

Poster Number: P6-10-13

Date: December 9th, 7:00 am CT

Data presented on CFI-402257, an oral, best-in-class TTK inhibitor, continue to show a tolerable safety profile at the recommended Phase 2 dose of 168 mg once daily with manageable, dose-dependent neutropenia being the primary toxicity. In this heavily pre-treated population (N=86), the overall response rate was 6% for monotherapy patients (4/66) and 10% for ER+/HER2- breast cancer patients treated in combination with fulvestrant (2/20). The clinical benefit rate (CR+PR+SD>6 months) for monotherapy and combination were 12% and 25%, respectively. Patients achieving stable disease or better stayed on treatment for a median of 242 days (range: 112 to 673). Significantly, several ER+ breast cancer patients who previously failed CDK4/6 inhibitors in the combination cohort remained on therapy for a year or more. The most common drug related toxicities of any grade, which occurred in greater than 10% of all patients, included fatigue (48%), nausea (48%), decreased appetite (34%), diarrhea (34%), vomiting (24%), constipation (21%) and headache (21%).