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Biotheryx Secures FDA Approval for Investigational New Drug Application of BTX-9341, a Novel Dual CDK4/6 Degrader

Wednesday, May 08, 2024

Biotheryx, Inc., a biopharmaceutical company focused on developing a range of first-in-class protein degraders targeting validated cancer and inflammatory disease pathways, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BTX-9341. This novel cyclin-dependent kinase 4/6 (CDK4/6) bifunctional degrader is intended for use in patients with HR+/HER2- breast cancer resistant to CDK4/6 inhibitor therapies. The company plans to initiate a Phase 1 clinical trial in the latter half of 2024 to evaluate the safety, biological activity, and preliminary efficacy of BTX-9341.

Biotheryx, expressed enthusiasm for the FDA clearance, stating, "Securing FDA clearance for our BTX-9341 IND application marks a significant milestone for Biotheryx, affirming our commitment to advancing innovative, orally bioavailable targeted protein degraders. As we transition from promising preclinical data to clinical trials, we are poised to explore the potential of BTX-9341 in offering tangible clinical benefits to patients battling breast cancer."

The Phase 1 clinical trial will include dose escalation for monotherapy administration of BTX-9341 and combination dose expansion with fulvestrant.

BTX-9341 is described as a first-in-class oral degrader of cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6), both significant targets in cancer, particularly in certain breast cancer subtypes. Preclinical studies have shown BTX-9341's superiority over CDK4/6 inhibitors, with potent and highly selective degradation of CDK4 and CDK6, robust inhibition of Cyclin E and CDK2 transcription, cell cycle arrest, and superior efficacy in breast cancer xenograft models. Additionally, BTX-9341 is differentiated from CDK4/6 inhibitors by its potential to overcome resistance mechanisms and enhanced blood-brain barrier penetration.



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