Treadwell Therapeutics’ CFI-402257 Granted Fast-Track Status by FDA

China-based clinical-stage biotech Treadwell Therapeutics has announced receiving fast-track status from the US Food and Drug Administration (FDA) for its CFI-402257, a best-in-class inhibitor of threonine tyrosine kinase (TTK, also known as Mps1). The designation was granted for the drug’s potential as a treatment for adult patients with ER+/HER2- advanced breast cancer following disease progression on prior CDK4/6 inhibitors and endocrine therapy, both as a monotherapy and in combination with fulvestrant.

Clinical Profile and Development
CFI-402257 has demonstrated early signs of durable activity and a manageable safety profile, positioning it as a promising treatment option for patients with advanced breast cancer. The fast-track designation from the FDA underscores the drug’s potential to address significant unmet needs in this patient population, particularly for those who have progressed after prior therapies.

Pipeline and Future Outlook
Treadwell Therapeutics boasts a robust clinical pipeline, including CFI-400945 (PLK4 inhibitor), CFI-402257, and CFI-402411 (HPK1 inhibitor). The company also has a pre-clinical pipeline with multiple biologic and next-generation TCR-based autologous cell therapy programs. The fast-track status for CFI-402257 highlights Treadwell’s commitment to advancing innovative therapies and underscores its dedication to improving patient outcomes in oncology.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry