Healx Doses First Patient in Phase 1/2 Trial of HLX-4310 for Relapsed and Refractory Sarcomas
Thursday, July 23, 2026
Healx has announced that the first patient has been dosed in a Phase 1/2 clinical trial evaluating HLX-4310, an investigational oral combination therapy for adolescents and adults with relapsed or refractory sarcoma, with a particular focus on osteosarcoma.
The dose-escalation and dose-confirmation study is designed to assess the safety, tolerability and efficacy of HLX-4310, which combines a class I selective histone deacetylase (HDAC) inhibitor with an mTOR inhibitor. The therapy is being investigated as a potential approach to reducing metastatic recurrence and disease progression.
Osteosarcoma is a rare and aggressive bone cancer that primarily affects children, adolescents and young adults. Patients who develop metastatic disease have poor long-term outcomes, and survival rates have shown limited improvement over the past four decades, highlighting the need for new treatment options.
HLX-4310 is the first programme in Healx's rare oncology strategy aimed at preventing metastatic recurrence, which is responsible for most cancer-related deaths. The company is using its artificial intelligence-driven drug discovery platform alongside laboratory and translational research to develop new combination therapies for rare cancers.
The clinical trial is being conducted in collaboration with the National Pediatric Cancer Foundation (NPCF) through its Sunshine Project™ research programme.
HLX-4310 is based on a strategy of targeting biological mechanisms that enable microscopic metastatic tumour cells to survive and later develop into recurrent metastatic disease. The investigational combination includes a class I selective HDAC inhibitor, designed to influence gene expression linked to tumour cell survival and immune interactions, together with an mTOR inhibitor that targets a key signalling pathway involved in cell growth, metabolism and stress responses.
The study will evaluate whether this combination approach can help reduce the risk of metastatic recurrence while establishing the therapy's safety profile in patients with relapsed or refractory sarcomas.
Source: globenewswire.com
