China-based Treadwell Therapeutics presented results of 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) annual meeting. The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemia.
Clinical Data and Safety Profile
Data presented on CFI-400945, an oral, first-in-class PLK4 inhibitor, 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. The most predominant severe AE was febrile neutropenia. No treatment-emergent adverse events led to study drug discontinuation.
Company Overview and Pipeline
Treadwell Therapeutics is a science-driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. The Company’s internally developed clinical pipeline includes CFI-400945, CFI-402257 (TTK inhibitor), and CFI-402411 (HPK1 inhibitor). The company is also advancing a pre-clinical pipeline of first-in-class antibody and TCR-based cell therapy assets.-Fineline Info & Tech
