Bio-Thera Granted FDA Approval for Phase II BAT8006 FRα ADC Trial

Bio-Thera Solutions, a biopharmaceutical firm based in Guangzhou, China, has secured approval from the US FDA to proceed with a phase II clinical trial for BAT8006, a novel Antibody Drug Conjugate (ADC) that targets the Folate Receptor α (FRα). This receptor is a protein that binds folic acid and is found on the membranes of cells, particularly overexpressed in solid tumors such as ovarian, lung, and breast cancer, while being less prevalent in healthy tissues. The unique expression pattern of FRα makes it an ideal target for developing cancer treatments.

The BAT8006 drug candidate has been engineered using Bio-Thera's proprietary anti-FRα antibody technology, coupled with a stable and cleavable ADC linker-payload system. This system includes a small molecule topoisomerase I inhibitor, which has been shown to have potent cell membrane penetration capabilities. This feature allows the drug to not only target and kill specific cancer cells but also to eliminate neighboring cancer cells, a phenomenon known as the "bystander effect." This effect is crucial as it may help to tackle the heterogeneity within tumors, which is a significant challenge in cancer treatment.

Preclinical studies have demonstrated BAT8006's stability, safety, and robust anti-tumor efficacy. Currently, a phase I clinical trial for BAT8006 is being conducted in China, where the initial dose escalation phase has been completed. The trial is now in the dose expansion and optimization phase for a range of tumor types. Early results from this trial suggest that BAT8006 has the potential to be a leading drug in its class. Further clinical data will be shared at upcoming academic conferences.

Bio-Thera Solutions is at the forefront of developing innovative therapeutics for a variety of severe medical conditions, including cancer, autoimmune diseases, cardiovascular diseases, and eye disorders. The company is also focused on creating biosimilars of existing biologic drugs to address unmet needs in treating cancer and autoimmune diseases. With a strong pipeline of over 20 candidates in clinical trials, Bio-Thera is particularly concentrating on immuno-oncology and targeted therapies post the PD-1 era.

The company has already seen success with three approved products: QLETLI® in China, and TOFIDENCE™/BAT1806 and Avzivi®/Pobevcy® in both the US and China. These achievements underscore Bio-Thera's commitment to advancing healthcare through cutting-edge research and development.