Senhwa Biosciences has announced a significant clinical milestone with its investigational drug Pidnarulex CX 5461 advancing into a Phase 1b combination study with Trastuzumab Deruxtecan Enhertu for patients with HER2 positive solid tumours and breast cancer including HER2 low and metastatic disease.
The trial will evaluate CX 5461 in combination with Enhertu the globally recognised antibody drug conjugate co developed by AstraZeneca and Daiichi Sankyo. The study is supported by the National Cancer Institute through its NExT programme which is funding multiple CX 5461 clinical studies including novel combination strategies.
CX 5461 is the world’s first and most advanced G quadruplex stabiliser in clinical development and has previously demonstrated encouraging activity in early phase trials across breast cancer and other solid tumours. By pairing this novel DNA targeting mechanism with the precision delivery platform of an ADC Senhwa aims to enhance efficacy particularly in HER2 low tumours where current HER2 targeted therapies show limited benefit.
The Phase 1b study will assess safety tolerability and optimal dosing of the CX 5461 and Enhertu combination in up to 36 patients. If successful the approach could open new therapeutic pathways expand indications and establish a differentiated position within one of oncology’s most competitive markets.
With the global ADC market projected to reach approximately USD 47 billion by 2029 Senhwa’s strategy signals a deliberate move into a high growth segment attracting increasing interest from multinational pharmaceutical companies. Analysts suggest positive clinical outcomes could unlock future licensing partnerships and strengthen Senhwa’s global oncology profile.
Building on its recent collaboration with BeOne Medicines in cold tumour immunotherapy Senhwa continues to broaden its development platform combining proprietary innovation with established global therapies reinforcing its ambition to emerge as a leading Asia based oncology innovator with international reach.
