Shandong Boan Biotechnology Co., Ltd. (BOAN BIOTECH) has received acceptance from China’s Center for Drug Evaluation of the National Medical Products Administration for a Phase II clinical trial assessing its anti-CD25 antibody BA1106 in combination with the company’s PD-1 inhibitor BA1104 (nivolumab injection) as first- or second-line therapy in non-small cell lung cancer (NSCLC).

The multicenter, single-arm, open-label study will evaluate efficacy, safety and pharmacokinetics in patients with driver gene-negative NSCLC—a segment that represents roughly 40%–50% of all NSCLC cases and currently faces limited post-progression treatment options.

BA1106 is positioned as China’s first investigational non-IL-2-blocking anti-CD25 (IL-2Rα) antibody entering clinical development for solid tumors. Engineered with “moderate” antibody-dependent cellular cytotoxicity and a unique epitope design, the molecule aims to selectively deplete regulatory T cells (Tregs) while preserving IL-2 signaling, thereby enhancing effector T-cell activity against tumors.

Phase I data for BA1106, both as monotherapy and in combination with BA1104, showed: • Encouraging antitumor activity in lung adenocarcinoma, squamous cell lung cancer and gastric cancer, including patients previously progressed on immune checkpoint inhibitors. • A favorable safety profile, with treatment-related adverse events primarily Grade 1–2. • No dose-limiting toxicities observed and no maximum tolerated dose reached up to 1.20 mg/kg during dose escalation.

Building on these findings, BOAN BIOTECH intends to expedite the Phase II program targeting treatment-naïve and post-immunotherapy NSCLC patients, while also planning to investigate the combination in other high-incidence solid tumors such as gastric cancer.