Boan Biologics Receives CDE Approval for Phase II Clinical Trial of BA1106 (Anti-CD25 mAb) in Combination with BA1104 (Anti-PD-1 mAb) for Non-Small Cell Lung Cancer

(Source: BoAn Biotech)

BoAn Biotech Announces That Its IND Application for a Phase II Clinical Trial of BA1106, an Innovative Anti-CD25 Monoclonal Antibody Developed In-House, 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.

Lung cancer is one of the most common malignant tumors worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 85% to 90% of all lung cancer cases.1. Among patients with non-small cell lung cancer (NSCLC), those negative for driver gene mutations account for approximately 40%–50%, and the incidence has been on the rise in recent years.2. Although the application of immune checkpoint inhibitors has brought significant benefits to patients with driver gene-negative NSCLC, most patients still face the issue of drug resistance, and treatment options after disease progression are limited; therefore, there remains a widespread and unmet clinical need.1。

Regulatory T cells (Tregs) are key immunosuppressive cells within the tumor microenvironment, widely present in various solid tumors. Their high infiltration levels are typically positively correlated with poor patient prognosis. Targeting Tregs has become a significant focus in cancer immunotherapy research. Leveraging its "moderate" antibody-dependent cellular cytotoxicity (ADCC) effect and unique binding site design, BA1106 selectively targets Tregs with high CD25 expression. This mechanism clears Tregs while increasing the number of effector T cells (Teffs) and avoiding interference with the IL-2 signaling pathway, thereby enhancing anti-tumor immune responses and demonstrating potential for the treatment of various solid tumors.

In the Phase I clinical trial, BA1106 in combination with 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 the dose-escalation phase, and the maximum tolerated dose was not reached even at the 1.2 mg/kg dose level.

With the initiation of Phase II clinical trials, BoAn Biotech will further validate the efficacy and safety of this combination regimen in patients with non-small cell lung cancer (NSCLC) who are either immunotherapy-naïve or have progressed after prior immunotherapy. The company will also continue to explore its therapeutic potential in other high-incidence solid tumors, such as gastric cancer, striving to deliver enhanced clinical benefits to patients in these disease areas at the earliest possible time.

About BoAn Biotech

BoAn Biotech (6955.HK) is a comprehensive, integrated biopharmaceutical company specializing in the development, manufacturing, and commercialization of biologics, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic disorders. The company’s new drug discovery activities are built upon multiple platforms, including a fully human antibody transgenic mouse platform, a bispecific/multispecific antibody and Probody® technology platform, an antibody-drug conjugate (ADC) technology platform, and an artificial intelligence/big data application platform. BoAn Biotech possesses a fully integrated industry chain encompassing antibody discovery, cell line development, upstream and downstream process development, analytical and bioanalytical method development, technology transfer, non-clinical studies, clinical trials, regulatory affairs and registration, and commercial-scale manufacturing.

Currently, BoAn Biotech has five products approved for market launch, along with a pipeline of innovative biologics and biosimilars under development that are protected by international intellectual property rights. The company has been recognized as a “National High-Tech Enterprise” and a national-level specialized, refined, distinctive, and innovative “Little Giant” enterprise. It also possesses provincial-level technical platforms, including the “Shandong Provincial New-type R&D Institution,” the “Shandong Engineering Research Center,” and the “Shandong Enterprise Technology Center.” Beyond China, BoAn Biotech is engaged in the development of biological drug products in overseas markets, including the United States, Europe, and Japan. Leveraging its differentiated product portfolio and increasingly mature commercialization capabilities, BoAn Biotech has established a comprehensive industrial value chain operational system covering “R&D – Manufacturing – Commercialization,” laying a solid foundation for its long-term, high-quality development.

References:

1.

Expert Committee on Non-Small Cell Lung Cancer of the Chinese Society of Clinical Oncology. Chinese Expert Consensus on Second-Line Treatment for Driver Gene-Negative Non-Small Cell Lung Cancer. Chin J Lung Cancer, February 2024, Vol.27, No.2. DOI: 10.3779/j.issn.1009-3419.2024.102.10

2.

Liu Huiling, Lao Mi, Cai Xiaoping, et al. Research Progress on Radiotherapy for Brain Metastases in Driver Gene-Negative Non-Small Cell Lung Cancer [J]. Chinese Journal of Radiation Oncology, 2024, 33(8): 766-771. DOI: 10.3760/cma.j.cn113030-20231125-00178