BOAN BIOTECH (06955): Application for Phase II clinical trial of BA1106 combined with BA1104 for the treatment of non-small cell lung cancer accepted by the China Drug Evaluation Center.

BOAN BIOTECH (06955) announced that the company has submitted an application for a Phase II clinical trial for the innovative antibody combination BA1106 (anti-CD25 monoclonal antibody) developed by the company itself, along with its own PD-1 inhibitor BA1104 (nivolumab monoclonal antibody) for the first-line and second-line treatment of non-small cell lung cancer (NSCLC). The application was recently accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The Phase II clinical trial will be a multicenter, single-arm, open-label study designed to systematically evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of BA1106 in combination with BA1104 in patients with driver gene-negative NSCLC. Lung cancer is one of the most common malignant tumors globally, with NSCLC accounting for 85%-90% of all lung cancer cases. Among NSCLC patients, driver gene-negative patients account for around 40%-50%, and their incidence has been increasing in recent years. Although immune checkpoint inhibitors have brought significant benefits to driver gene-negative NSCLC patients, many patients still face issues with resistance, and treatment options after disease progression are limited, highlighting the ongoing and unmet needs in the clinical setting. Regulatory T cells (Tregs) play a key role as immune suppressor cells in the tumor microenvironment and are widely present in various solid tumors. Targeting Tregs has become an important research direction in tumor immunotherapy. BA1106 is the first innovative antibody in China to enter clinical stages and be used for solid tumor treatment as a non-IL-2 blocking anti-CD25 (interleukin-2 receptor subunit, IL-2R) monoclonal antibody. With moderate ADCC effects and a unique binding site design, BA1106 selectively targets Tregs with high expression of CD25, enhancing the number of T effector cells while avoiding interference with the IL-2 signaling pathway, thereby strengthening the anti-tumor immune response and having the potential to treat various solid tumors. In Phase I clinical trials, positive efficacy signals were observed with BA1106 in combination with BA1104 in patients with lung adenocarcinoma, squamous cell lung cancer, gastric cancer, and other solid tumors who had previously received immune checkpoint inhibitor therapy and experienced disease progression. Safety results showed that both monotherapy with BA1106 and combination with BA1104 demonstrated good safety and tolerability, with the majority of treatment-related adverse events being grade 1-2. No dose-limiting toxic events were observed during dose escalation, and even at the 1.2mg/kg dose group, the maximum tolerated dose was not reached, supporting the advancement of further clinical studies. BA1106 achieves a good balance between efficacy and safety through precise regulation of Tregs to enhance the anti-tumor immune response. Phase I clinical studies have shown the synergistic potential of BA1106 in combination with PD-1 inhibitors and observed positive efficacy signals in multiple tumor types. The company will actively advance the combination therapy in Phase II clinical development in NSCLC patients with immunotherapy nave and post-progression, and will continue to explore its therapeutic potential in other high-incidence solid tumors such as gastric cancer, with the goal of bringing better clinical benefits to patients in relevant disease areas.