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Treadwell Therapeutics Begins Trial of CFI-402257 in Patients With Solid Tumors, Breast Cancer

NEW YORK – Treadwell Therapeutics this week said it has started a Phase Ib/II trial evaluating its threonine tyrosine kinase inhibitor CFI-402257 in patients with solid tumors and advanced estrogen receptor-positive HER2-negative breast cancer.

The open-label dose optimization trial will gauge the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of CFI-402257 in around 40 patients across 10 sites in the US. The first patient received the drug at START Mountain Region in Salt Lake City earlier this month.

"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" Justin Call, director of clinical research at START Mountain Region and the study's principal investigator, said in a statement. 

The study will establish the dose of the drug as a single agent in patients with advanced solid tumors and then test the recommended Phase II dose in patients with solid tumors and in combination with fulvestrant in breast cancer patients. In the study, researchers will also track changes in variant allele function after treatment in ctDNA compared to baseline.

"Previous clinical studies have demonstrated that CFI-402257 has a tolerable safety profile and confirmed responses in ER-positive/HER2-negative breast cancer after progression on CDK4/6 inhibitors," Treadwell co-CEO Michael Tusche said in a statement. "We look forward to the continued development of this molecule in breast cancer."

New York City-based Treadwell has a number of drugs in development, including the PLK4 inhibitor, CFI-400945. This agent is being studied within an ongoing Phase II umbrella trial, which is exploring the activity of a range of biomarker-matched treatments for metastatic castration-resistant prostate cancer (mCRPC) patients. The company last year acquired TCRyption in order to bring T-cell receptor-based autologous therapies into its pipeline.