By Fineline Cube Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its epidermal growth factor receptor (EGFR)-targeted monoclonal antibody (mAb), HLX07, in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). This marks a significant step forward in the development of HLX07 for the treatment of advanced solid tumors.
Clinical Development of HLX07
HLX07 has already concluded a Phase Ia clinical study in Taiwan and is currently undergoing Phase Ib or Phase II clinical trials in mainland China. Additionally, Phase II clinical studies for the programmed-death 1 (PD-1) mAb serplulimab in combination with HLX07 are ongoing in China for head and neck squamous cell carcinoma (HNSCC), squamous non-small cell lung cancer (sq. NSCLC), and other solid tumors. A Phase II study for serplulimab combined with HLX07 plus bevacizumab in first-line unresectable or metastatic hepatocellular carcinoma (HCC) has also been approved.
Global Market Context
Globally, available EGFR inhibitors include Merck’s Erbitux (cetuximab), Amgen’s Vectibix (panitumumab), and Bio-Thera Solutions’ nimotuzumab. These drugs generated a combined global sales of $2.51 billion in 2021. The approval for HLX07’s clinical study by the FDA positions Henlius Biotech to potentially contribute to this growing market segment.-Fineline Info & Tech