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Drug intelligence / Profile preview
HLX-4310
- Development stage
- Phase 2
- Lead developer
- Healx
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
HLX-4310 is an investigational small molecule combination therapy consisting of the histone deacetylase (HDAC) inhibitor domatinostat and the mTOR inhibitor sirolimus. Developed by Healx, the therapy is designed to target the prevention of metastatic recurrence in osteosarcoma, a rare and aggressive pediatric bone cancer. By simultaneously inhibiting HDAC and mTOR pathways, HLX-4310 aims to disrupt the survival mechanisms of cancer cells that lead to relapse. The program was acquired from Vuja De Sciences in September 2025 and has received FDA Investigational New Drug (IND) clearance to proceed into Phase 1/2 clinical trials in collaboration with the National Pediatric Cancer Foundation's Sunshine Project, focusing on adolescent and adult patients with relapsed or refractory sarcoma.
- Other names
- domatinostat + sirolimus
02
Targets
HDAC (HDAC family)Mechanistic target of rapamycin complex 1
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