Degron Therapeutics' DEG6498 Receives FDA Clearance for Clinical Trials

Degron Therapeutics’ DEG6498 Receives FDA Clearance for Clinical Trials

China-based Degron Therapeutics, a developer of molecular glue-based drugs, announced that the U.S. Food and Drug Administration (FDA) has granted clinical clearance for DEG6498, its molecular glue degrader (MGD) targeting human antigen R (HuR). The drug will enter early-stage trials to assess its safety and efficacy in solid tumors.

Drug Profile
DEG6498 induces interaction between E3 ubiquitin ligase Cereblon (CRBN) and RNA-binding protein HuR, promoting targeted degradation of HuR. The protein plays a critical role in cancer, inflammation, and metabolic diseases. The MGD mechanism aims to disrupt disease pathways by degrading key regulatory proteins.

Clinical Trial Details
The Phase I/II trial will evaluate DEG6498’s safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity in patients with multiple solid tumors. The study marks Degron’s first clinical program in the U.S., leveraging its molecular glue platform to address unmet oncology needs.

Strategic Outlook
The FDA approval positions DEG6498 as a potential first-in-class therapy for solid tumors. Degron plans to expand its pipeline of molecular glue degraders, targeting proteins previously considered “undruggable.”-Fineline Info & Tech

Insight, China's Pharmaceutical Industry