Clinical TrialMay 14, 2026, 05:32 PM
GYRE Therapeutics to Present CG923308 Cancer Data; IND Filing Q1 2027
AI Summary
GYRE Therapeutics, Inc. announced it will present data on its CDK2-Cyclin E degrader, CG923308, at a scientific conference in Shanghai, China, on May 15, 2026. The presentation highlights CG923308's potential for treating solid tumors with CCNE1 amplification and CDK4/6i-resistant HR+/HER2- breast cancers, showing superior preclinical efficacy. The company, which recently acquired Cullgen, anticipates submitting an Investigational New Drug (IND) application for CG923308 in the first quarter of 2027.
Key Highlights
- GYRE Therapeutics to present data on its CDK2-Cyclin E degrader, CG923308, at a scientific conference.
- Anticipates submitting an Investigational New Drug (IND) application for CG923308 in Q1 2027.
- CG923308 targets CCNE1-amplified solid cancers, estimated at >25,000 new US cases annually.
- Also targets CDK4/6i-resistant HR+/HER2- breast cancer, affecting ~25,000 US patients annually.
- Preclinical data shows potent and selective CDK2-Cyclin E degradation in multiple cancer types.
- CG923308 demonstrated superior anti-cancer efficacy over Phase 2/3 CDK2 inhibitors in preclinical models.
- The drug candidate is orally bioavailable across preclinical species with F% >15-60%.
- GYRE Therapeutics, including Cullgen, has ~740 employees worldwide, with ~170 in R&D.
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