On December 13, 2022 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel, small molecule therapeutics for highly aggressive cancers, reported a presentation for the Company’s CFI-400945 program, a first in class inhibitor of Polo-like Kinase 4 (PLK4) a critical regulator of centriole duplication, at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held from December 10-13, 2022 (Press release, Treadwell Therapeutics, DEC 13, 2022, View Source [SID1234625233]). The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.

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"CFI-400945 had previously shown single agent complete remissions in refractory high risk AML. As we optimize dose for the agent in unselected leukemia patients in study TWT-202, we are encouraged by the continued signs of safety and tolerability with this oral dosing regimen," said Principal Investigator, Dr. Gautam Borthukar, MD, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center.

"We look forward to dose selection for CFI-400945, and expansion into populations of interest, including patients with TP53 mutations, where there is substantial unmet need," said Dr. Michael Tusche, Co-CEO at Treadwell Therapeutics.

2022 ASH (Free ASH Whitepaper) Poster Presentations and Details:

Preliminary Results from a Phase 2 Open-Label, Multicenter, Dose Optimization Clinical Study of the Safety, Tolerability, and Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of CFI-400945 As a Single Agent or in Combination with Azacitidine or Decitabine in Patients with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (TWT-202)

Publication Number: 4087
Session: 616; Poster III
Date and Time: December 12th, 2022, 6:00 PM-8:00 PM

Data presented on CFI-400945, an oral, first-in-class PLK4 inhbitor, showed a tolerable safety profile at the 32, 48 and 64 mg cohorts (N=12), with exposures being approximately dose linear. No dose limiting toxicities have been observed to date, suggesting further dose optimization is required. Five cases of stable disease have been observed – 3 per ELN with 1 at 48 mg, and 2 at 64 mg, as well as 2 at 48 mg per IWG. Adverse events (AEs) for CFI-400945 in this study were in line with those observed in previous studies in similar patient populations. Main AEs (any grade) were hematologic, gastrointestinal and metabolism/nutritional disorders. Most predominant severe AE was febrile neutropenia. No treatment emergent adverse events led to study drug discontinuation.