China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its BA1106, an in-house developed CD25 monoclonal antibody (mAb). The study, filed by subsidiary Shandong BoAn Biotechnology Co., Ltd, is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of the drug in advanced solid tumors. This marks a significant step in the development of a new therapeutic approach for various types of cancer.
Targeting CD25 and Therapeutic Potential
CD25 targets the interleukin-2 receptor alpha subunit (IL-2Rα), which is highly expressed in regulatory T cells (Treg cells). BA1106, developed via BoAn’s fully human antibody transgenic mice and phage display technology platform, is a broad-spectrum anti-tumor immune drug. It has therapeutic potential for a range of cancers, including cervical, renal, ovarian, melanoma, pancreatic, hepatocellular, gastric, and breast cancer. The drug is designed to reduce Treg cells in the tumor microenvironment and increase the proportion of effector T cells through antibody-dependent cell-mediated cytotoxicity (ADCC) effects.
Clinical Trial Approval and Progress
The drug obtained clinical trial approval in China in September last year. The initiation of the Phase I clinical study is a crucial milestone in bringing this innovative treatment closer to patients. The study aims to evaluate the drug’s safety and efficacy in treating advanced solid tumors, providing valuable data for further development and potential market approval.-Fineline Info & Tech
