BOAN BIOTECH (06955) has announced that the application for a Phase II clinical trial of its self-developed innovative antibody BA1106 (an anti-CD25 monoclonal antibody) in combination with its proprietary PD-1 inhibitor BA1104 (Nivolumab) for the first-line and second-line treatment of non-small cell lung cancer (NSCLC) has recently been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This Phase II trial will adopt a multi-center, single-arm, open-label design. It is planned to systematically evaluate the efficacy, safety, and pharmacokinetic (PK) profile of the BA1106 and BA1104 combination in subjects with driver gene-negative NSCLC.

Lung cancer is one of the most common malignant tumors worldwide, with NSCLC accounting for approximately 85%-90% of all lung cancer cases. Among NSCLC patients, those with driver gene-negative disease represent about 40%-50%, and the incidence has shown an increasing trend in recent years. Although the use of immune checkpoint inhibitors has provided significant benefits for driver gene-negative NSCLC patients, many still face issues of drug resistance. Furthermore, treatment options are limited after disease progression, indicating a broad and unmet clinical need.

Regulatory T cells (Tregs) are key immunosuppressive cells within the tumor microenvironment, widely present in various solid tumors. A high level of Treg infiltration is often closely associated with poor patient prognosis. Targeting Tregs has become an important research direction in cancer immunotherapy. BA1106 is the first non-IL-2 blocking anti-CD25 (Interleukin-2 receptor alpha subunit, IL-2Rα) innovative antibody in China to enter the clinical stage for the treatment of solid tumors. Leveraging a "moderate" ADCC effect and a unique binding site design, BA1106 selectively targets Tregs with high CD25 expression. It works by clearing Tregs while increasing the number of Teff cells and avoiding interference with the IL-2 signaling pathway, thereby enhancing the anti-tumor immune response and demonstrating potential for treating a variety of solid tumors.

In Phase I clinical trials, the BA1106 and BA1104 combination showed positive efficacy signals in subjects with various solid tumors, including lung adenocarcinoma, lung squamous cell carcinoma, and gastric cancer. These subjects had previously been treated with immune checkpoint inhibitors and experienced disease progression. Safety results indicated that BA1106, whether used as a monotherapy or in combination with BA1104, demonstrated a favorable safety profile and tolerability. The vast majority of treatment-related adverse events were Grade 1 or 2. During the dose escalation phase, no dose-limiting toxicities were observed, and the maximum tolerated dose was not reached even at the 1.2 mg/kg dose level, providing support for the advancement of subsequent clinical studies.

Through its precise regulation of Tregs, BA1106 achieves a favorable balance between efficacy and safety while enhancing the anti-tumor immune response. Phase I clinical research has already demonstrated the synergistic potential of BA1106 combined with a PD-1 inhibitor, with positive efficacy signals observed across multiple tumor types. The company will actively advance the Phase II clinical development of this combination regimen in NSCLC patients who are immunotherapy-naïve or have progressed after immunotherapy. It will also continue to explore its therapeutic potential in other high-incidence solid tumors, such as gastric cancer, striving to deliver better clinical benefits for patients in related disease areas.