Appclon announced on the 11th that it has received approval for the clinical trial application (IND) from the National Medical Products Administration (NMPA) of China for a new Phase 2 clinical trial of AC101 (HENLIUS code name HLX22), which is being developed as a treatment for various solid tumor indications. AC101 is a pipeline that was licensed to HENLIUS, a subsidiary of Fusheng Pharmaceuticals.
The AC101 clinical trial will be conducted in combination with trastuzumab and chemotherapy or in combination with trastuzumab deruxtecan (T-DXd). It is being developed to target the treatment of various solid tumors expressing HER2 (human epidermal growth factor receptor 2).
The HER2 protein targeted by AC101 is found to be a major cause in various cancers including breast cancer, gastric cancer, cholangiocarcinoma, pancreatic cancer, urothelial carcinoma, lung cancer, and ovarian cancer. Based on safety and tolerability, the Phase 2 clinical trial of AC101 for HER2-positive metastatic gastric cancer showed more than a sixfold improvement in patient survival and anti-cancer response. The company explained that this also suggests potential therapeutic effects for various HER2-positive solid tumors.
An Appclon representative stated, “Based on the excellent existing clinical results, rapid expansion of indications is expected to be possible,” and added, “Innovative therapeutic effects are anticipated for patients with various solid tumors.”
Meanwhile, the company has received approval for a Phase 3 international multicenter study of HLX22 in combination with trastuzumab for HER2-positive gastric cancer patients in China, the United States, Japan, and Australia. Patient dosing is currently underway.
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