FDA Clears Biotheryx’s IND of Btx-9341 for HR+/HER2- Breast Cancer

May 11, 2024

FDA has cleared Biotheryx’s Investigational New Drug (IND) application for BTX-9341, a first-in-class, orally bioavailable degrader targeting cyclin-dependent kinase 4/6 (CDK4/6) for treating HR+/HER2- breast cancer.

The clearance marked a significant milestone for Biotheryx, emphasizing their commitment to innovative protein degraders for HR+/HER2- breast cancer.

The upcoming phase 1 trial will assess BTX-9341’s safety and efficacy in patients with HR+/HER2- breast cancer resistant to current CDK4/6 inhibitors.

Leah Fung, CEO of Biotheryx, acknowledged the FDA for clearing the BTX-9341 IND application by highlighting how this achievement supported Biotheryx commitment to advancing innovative, orally bioavailable targeted protein degraders.

She highlighted the pivotal step of transitioning from preclinical data to clinical trials, emphasizing the potential of BTX-9341 to offer tangible clinical benefits to patients battling breast cancer.

Preclinical data has shown promising results, with BTX-9341 demonstrating the potential to overcome resistance mechanisms and achieve superior efficacy compared to existing drugs.

The IND approval highlighted Biotheryx’s expertise in protein degradation and underscored BTX-9341’s potential for HR+/HER2- breast cancer patients.

Source: Biotheryx Announces U.S. FDA Clearance of Investigational New Drug Application for BTX-9341, a First-In-Class, Dual Bifunctional Degrader of CDK4/6