Boan Biotech Receives CDE Clearance for Phase Ⅱ Clinical Trial of BA1106 in Combination with BA1104 for NSCLC

Yantai, July 2, 2026 –- Boan Biotech announced today that China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has cleared the company’s application for a Phase Ⅱ clinical trial of its proprietary anti-CD25 antibody BA1106 in combination with its PD-1 inhibitor BA1104(a nivolumab biosimilar) as first-line or second-line regimens for non-small cell lung cancer (NSCLC). 

BA1106 is the first investigational non-IL-2-blocking anti-CD25 (IL-2Rα) antibody in China to initiate clinical trials for the treatment of solid tumors. The Phase Ⅱ clinical trial is a multicenter, single-arm, open-label study designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of BA1106 in combination with BA1104 in patients with driver gene-negative NSCLC. The study is expected to generate critical data to support the company's exploration of novel immunotherapy strategies.

Lung cancer remains one of the most prevalent malignancies in the world, and NSCLC accounts for 85% to 90% of all cases¹. Among patients with NSCLC, approximately 40% to 50% are driver gene-negative, and their incidence is steadily increasing².  Although the advent of immune checkpoint inhibitors (ICIs) has significantly improved patient outcomes, most patients will eventually develop drug resistance. For them, the lack of effective treatment options following disease progression is a critical unmet need¹.

Present across various solid tumors, regulatory T cells (Tregs) are critical immunosuppressive components of the tumor microenvironment, where high infiltration typically correlates with poor clinical outcomes. As such, targeting Tregs has become a focal point of next-generation cancer immunotherapy. With “moderate” ADCC activity and a unique binding epitope design, BA1106 selectively targets CD25-overexpressing Tregs. While depleting Tregs, it expands effector T cell (Teff) populations and preserves IL-2 signaling, thereby enhancing anti-tumor immune responses and demonstrating potential for the treatment of multiple solid tumors. 

In the Phase Ⅰ clinical trial, the combination of BA1106 and BA1104 showed encouraging efficacy signals in patients with lung adenocarcinoma, squamous cell lung cancer, and gastric cancer, and all of them had previously experienced disease progression on ICIs. Furthermore, BA1106 demonstrated a favorable safety and tolerability profile as a monotherapy or in combination with BA1104. Most treatment-related adverse events were mild (Grades 1–2). During dose escalation, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached at dose levels up to 1.2 mg/kg. These results are encouraging for subsequent clinical studies. 

With the initiation of this Phase Ⅱ clinical trial, Boan Biotech will further evaluate the efficacy and safety of this combination regimen in patients with NSCLC who are immunotherapy-naïve as well as those whose disease has progressed after prior immunotherapy. The company will also explore the therapeutic potential of this regimen in other high-incidence solid tumors, such as gastric cancer, in an effort to deliver improved clinical outcomes for patients.

References：
1.  Expert Committee on Non-small Cell Lung Cancer, the Chinese Society of Clinical Oncology: Chinese Expert Consensus on Second-line Treatment for Non-small Cell Lung Cancer with Negative Driver Gene Mutations. Chin J Lung Cancer, February 2024, Vol.27, No.2. DOI: 10.3779/j.issn.1009-3419.2024.102.10.
2.  Liu H, Lao M, Cai X, et al., Research Progress in Radiotherapy for Brain Metastases of Driver-Gene Negative Non-Small Cell Lung Cancer. Chinese Journal of
Radiation Oncology, 2024, 33(8): 766-771. DOI: 10.3760/cma.j.cn113030-20231125-00178.