Shanghai, September 7, 2022 - Luye Pharma Group announced today that BA1106, a human anti-CD25 monoclonal antibody developed by its subsidiary Boan Biotech, has been approved for clinical trials by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This makes BA1106 the first investigational anti-CD25 antibody to start clinical trials in China for treating solid tumors. Focusing on key therapeutic areas including oncology, Boan Biotech has been speeding up the development of novel drugs. It now has a number of investigational antibodies in its pipeline that are protected by international intellectual property rights.  

BA1106 is a broad-spectrum immuno-oncology drug with strong potential

CD25, known as interleukin-2 receptor α (IL-2Rα), is highly expressed on regulatory T cells (Treg cells) and is a potential target for Treg deletion. Treg cells inhibit various immune cells and are also an important factor contributing to poor prognosis of most solid tumors. Therefore, eliminating Treg cells in the tumor microenvironment becomes an important strategy for immuno-oncology. Anti-CD25 antibodies are broad-spectrum immuno-oncology drugs with the potential to treat cervical cancer, renal cancer, ovarian cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, gastric cancer, and breast cancer. However, developing anti-CD25 antibodies faces two major challenges today: first, the function of Fc as mediators is limited, and as a result, they only work in early-stage tumor models, not in advanced tumor models; second, the IL-2 signaling pathway is blocked, leading to poor antitumor outcomes. The main mechanism of action of BA1106 is to deplete Treg cells in the tumor microenvironment through the antibody-dependent cellular cytotoxicity (ADCC) and increase the number of effector T cells. Preclinical studies have shown that BA1106 demonstrated a good therapeutic effect on both early-stage and advanced tumors as well as a synergy when used in combination with an anti-PD-1 antibody. Moreover, BA1106 does not block the IL-2 signaling pathway, and depletes Treg cells moderately and specifically. The related research results of BA1106 have been published in Scientific Reports, a journal of the Nature Portfolio.  

Facilitating the efficient development of innovative antibodies with proprietary platforms

BA1106 was developed by Boan Biotech on its transgenic mouse and phage display platforms for human antibodies. BA-huMab® is the company’s proprietary transgenic mouse platform for human antibodies. It is a leading platform in China. This platform can directly generate human antibodies without humanization, to significantly accelerate the antibody discovery process and reduce the immunogenicity risk. In addition, it is able to elicit an immune response quickly and produce a high antibody titer after immunization. Boan Biotech has successfully identified high-affinity and high-specificity potential candidates with over 10 targets on this platform. In addition to BA1106, there are also LY-CovMab for treating COVID-19, anti-Claudin 18.2 antibody BA1105, and anti-PD-L1/TGF-β bispecific antibody BA1201. Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: "Based on our innovation and commercialization capabilities, we have built a differentiated pipeline including multiple innovative antibodies. It’s exciting to see that BA1106 becomes the first investigational anti-CD25 antibody to start clinical trials in China for treating diverse solid tumors. This drug has demonstrated broad-spectrum anti-tumor potential in preclinical studies and is expected to provide a new immunotherapy for cancer patients. We will accelerate the development of BA1106 to serve the unmet therapeutic needs of patients.”  

About Boan Biotech

As a subsidiary of Luye Pharma Group, Boan Biotech is a fully integrated biopharmaceutical company that specializes in developing, manufacturing and commercializing therapeutic antibodies with a focus on key therapeutic areas including oncology, autoimmune diseases, ophthalmology, and metabolism. The company’s antibody discovery is based on three technology platforms🐷: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform and ADC Technology Platform. The company has built a robust pipeline including multiple innovative antibodies protected internationally for intellectual property rights as well as biosimilars. Its first biologic product Boyounuo® (Bevacizumab Injection) haꦿs been launched in China.

Boan Biotech operates across the entire value chain of the industry from antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, technology transfer to pilot and commercial scale prod🍬uction. In addition to China, the company is a🍸lso developing biopharmaceutical products in the U.S. and the EU countries.