On December 8, 2021 Treadwell Therapeutics, reported a presentation for the Company’s CFI-402257 program, an oral, best-in-class TTK inhibitor, at the 2021 San Antonio Breast Cancer Symposium (SABCS) being held from December 7-10, 2021 (Press release, Treadwell Therapeutics, DEC 8, 2021, View Source [SID1234596605]). This presentation will describe dose escalation and expansion data from CFI-402257-CL-001, an investigator-initiated study of CFI-402257 in advanced solid tumors.

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"The anti-tumor activity observed with CFI-402257 alone or in combination with Fulvestrant in patients with ER+/Her2- breast cancer, including patients previously treated with CDK4/6 inhibitors, is encouraging and warrants further investigation" said Dr. Phillipe Bedard, Study investigator, Associate Professor of Medicine at the University of Toronto and Staff Medical Oncologist at the Princess Margaret Cancer Centre, Toronto, Canada. "We look forward to additional data from this study, as well as the initiation of our company sponsored TWT-203 trial in ER+/Her2- breast cancer," added Dr. Michael Tusche, Treadwell co-CEO.

2021 SABCS Poster Presentations and Details:
CFI-402257-CL-001: An Open-Label, Dose Escalation, Safety, and Pharmacokinetic Study of CFI-402257
Administered Orally to Patients with Advanced Solid Tumors
Poster Number: P1-18-17
Date: December 8th, 7:00 am – 8:30 pm

In this presentation, CFI-402257 demonstrated a tolerable safety profile at doses up to 168 mg QD and linear pharmacokinetics, with 168 mg as the RP2D. In this heavily pre-treated, all-comer patient population (N=67), 25 patients (53.2%) showed disease control (SD+PR+CR) and 5 patients showed confirmed PRs (10.6%), 4 patients with ER+/Her2- breast cancer and 1 with hepatocellular carcinoma. Two of the breast cancer patients were treated with monotherapy and two were treated in combination with fulvestrant. The median duration of response for the breast cancer patients was 256 days with PRs coming after only 2 cycles. The most common drug related toxicities of any grade, which occurred in greater than 10% of patients, were nausea (29.9%), fatigue (22.4%), decreased appetite (20.9%), diarrhea (16.4%), vomiting (13.4%), neutrophil count decrease (11.9%), alopecia (10.4%), neutropenia (10.4%), and white blood cell count decrease (10.4%)