Biotheryx Receives FDA Clearance for BTX-9341 IND Application

SAN DIEGO, May 7, 2024 - BIOTHERYX INC, a company in the biopharmaceutical sector focusing on first-in-class protein degraders for cancer and inflammatory diseases, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application concerning BTX-9341. BTX-9341 is an innovative cyclin-dependent kinase 4/6 (CDK4/6) bifunctional degrader. Biotheryx plans to commence Phase 1 clinical trials in the latter half of 2024, targeting patients with HR+/HER2- breast cancer who have shown resistance to CDK4/6 inhibitor therapies.

"Receiving FDA clearance for our BTX-9341 IND application is a pivotal achievement for Biotheryx. It underscores our dedication to progressing novel, orally bioavailable targeted protein degraders. As we move from promising preclinical data to clinical trials, we're ready to investigate the potential of BTX-9341 to offer real clinical benefits to breast cancer patients," stated Leah Fung, Ph.D., CEO of Biotheryx.

The Phase 1 clinical trial of BTX-9341 will start with a dose-escalation phase for monotherapy and will later include a combination dose expansion phase, pairing BTX-9341 with fulvestrant. This initial clinical assessment will primarily focus on evaluating the safety, biological activity, and preliminary efficacy of BTX-9341.

BTX-9341 stands out as a pioneering oral degrader of cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6). These kinases are critical targets in a variety of cancers, particularly certain types of breast cancer. Preclinical models of breast cancer have shown that BTX-9341 outperforms CDK4/6 inhibitors through potent and highly selective degradation of CDK4 and CDK6. It also robustly inhibits Cyclin E and CDK2 transcription, leading to cell cycle arrest and ultimately superior in vivo efficacy in breast cancer xenografts.

BTX-9341’s potential advantages extend beyond increased efficacy. Importantly, it may overcome key resistance mechanisms that limit the effectiveness of current CDK4/6 inhibitors. Approximately 20% of patients exhibit intrinsic resistance to these inhibitors, and up to 70% develop acquired resistance. Additionally, BTX-9341 shows significantly enhanced penetration of the blood-brain barrier, which could offer further clinical benefits.

Biotheryx, Inc. is dedicated to discovering and developing first-in-class protein degraders, including bifunctional degraders and molecular glues. The company's primary focus is on validated targets in cancer and inflammatory diseases. The team's previous work includes developing the first FDA-approved modulators of Cereblon, a critical E3 ligase involved in protein degradation. Biotheryx has leveraged this expertise to create its proprietary PRODEGY platform. 

The company’s pipeline features several promising candidates, including BTX-9341 for HR+/HER2- breast cancer. BTX-9341 is the first bifunctional degrader of CDK4 and CDK6 to gain IND approval from the FDA. Other candidates in the pipeline include first-in-class degraders targeting SOS1 for pan-KRAS mutant cancers and PDE4 for inflammatory diseases.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!