Shenzhen Chipscreen Biosciences Co., Ltd. has announced that its novel drug, Chiauranib, has been approved by the National Medical Products Administration for a Phase III clinical trial. This trial will investigate Chiauranib in combination with a PD-(L)1 monoclonal antibody and standard chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
ES-SCLC presents a significant therapeutic challenge due to its aggressive nature. While chemo-immunotherapy has improved survival outcomes, there remains a need for therapies that can further enhance long-term survival. Chiauranib's multi-pathway mechanism of action, which includes anti-angiogenesis and immune modulation, suggests it could synergize with existing treatments.
Chiauranib's Novel Mechanism
Chiauranib is a selective inhibitor of Aurora B, a key mitotic regulator, and also targets VEGFR to inhibit tumor angiogenesis. Additionally, it blocks CSF1R and DDR1 pathways, reducing the infiltration and activity of immunosuppressive cells within the tumor microenvironment. This triple-pathway mechanism allows Chiauranib to exert comprehensive anti-tumor effects.
According to Chipscreen Biosciences, Chiauranib has demonstrated a superior efficacy and safety profile compared to drugs with similar mechanisms. The company believes that the addition of Chiauranib to first-line chemo-immunotherapy regimens has the potential to significantly improve long-term survival rates for patients with ES-SCLC.
Ongoing Clinical Trials
In addition to the newly approved Phase III trial, a Phase III clinical trial of Chiauranib monotherapy for later-line treatment of small cell lung cancer has been completed, and pre-NDA communication is underway. Chiauranib is also being evaluated in Phase III trials for ovarian cancer (in combination with chemotherapy) and Phase II trials for triple-negative breast cancer, soft tissue sarcoma, and pancreatic cancer (as both single agent and combination therapy). An ongoing Phase Ib/II clinical trial in the United States is investigating Chiauranib monotherapy for small cell lung cancer and other solid tumors.
About Chipscreen Biosciences
Chipscreen Biosciences is an innovative drug company focused on developing novel therapies for a range of diseases, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and viral infections. The company has a global presence with research and development centers in China and the United States.
