Boan Biologics (06955.HK): Phase II Clinical Trial of BA1106 in Combination with BA1104 for Non-Small Cell Lung Cancer Receives CDE Approval

BoAn Biotech(06955) announced that the application for a Phase II clinical trial of its independently developed innovative antibody BA1106 (anti-CD25 monoclonal antibody) in combination with its proprietary PD-1 inhibitor BA1104 (nivolumab) for first-line and second-line treatment of non-small cell lung cancer (NSCLC) has been officially approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.

BA1106 is the first innovative non-IL-2-blocking anti-CD25 (interleukin-2 receptor alpha subunit, IL-2Rα) antibody to enter clinical development in China for the treatment of solid tumors. The approved Phase II clinical trial employs a multicenter, single-arm, open-label design, aiming to systematically evaluate the efficacy, safety, and pharmacokinetic (PK) profile of BA1106 in combination with BA1104 in patients with driver gene-negative non-small cell lung cancer (NSCLC). This clinical trial will provide critical data support for the company’s exploration of novel immunotherapy strategies.

In Phase I clinical trials, the combination of BA1106 and BA1104 has demonstrated positive efficacy signals in patients with various solid tumors, including lung adenocarcinoma, lung squamous cell carcinoma, and gastric cancer. All enrolled patients had previously received immune checkpoint inhibitor therapy and experienced disease progression. Safety results indicated that BA1106, whether administered as monotherapy or in combination with BA1104, exhibited a favorable safety and tolerability profile, with the vast majority of treatment-related adverse events being Grade 1–2. No dose-limiting toxicities were observed during dose escalation, and the maximum tolerated dose was not reached even at the 1.2 mg/kg dose level.