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ImmuneOnco Successfully Convenes Phase II Investigator Meeting for IMC-002 (IMM0306) in Active Systemic Lupus Erythematosus (SLE)
2026-07-27
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Luoyang, Henan, China – July 26, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" or the "Company"; HKEX Stock Code: 01541.HK) announced today that the investigator meeting for the Phase II clinical study (IMC-002-S-01) of IMC-002 (IMM0306) for active systemic lupus erythematosus (SLE) was successfully held in Luoyang, Henan. The meeting brought together principal investigators (PIs) and clinical experts from over 40 core clinical research centers nationwide, including Peking University People's Hospital and Qilu Hospital of Shandong University. The event aimed to provide a comprehensive overview of the study protocol and unify trial execution standards, laying a solid foundation for the clinical study that is now fully underway.


The investigator meeting was chaired by Professor Li Zhanguo from Peking University People's Hospital. Dr. Tian Wenzhi, Chairman, CEO, and CSO of ImmuneOnco, and Professor Li delivered the opening remarks together. Subsequently, Dr. Wu Zhuli, Chief Medical Officer; Dr. Zhang Jinchao, Medical Director; and Dr. Xu Zhenzhi, Medical Manager, presented detailed reports on the Company's R&D pipeline, disease area research progress, and the Phase II study protocol. Professor Shu Qiang from Qilu Hospital of Shandong University and Professor Meng Tianli from Jilin Provincial People's Hospital also shared valuable insights on patient enrollment strategies.


As the lead PI of the coordinating center for this study, Professor Li Zhanguo welcomed the attending experts in his address, noting: "Systemic lupus erythematosus is a complex autoimmune disease with significant unmet clinical needs. As an innovative dual-target therapy, the early clinical data for IMC-002 have shown encouraging potential. The scientific rigor of this Phase II study design provides a solid foundation for validating its efficacy and safety. I look forward to working with investigators across all centers to execute this study to the highest standards and bring new treatment hope to SLE patients as soon as possible."


Following this, Dr. Tian Wenzhi elaborated on the strategic significance of IMC-002's development from a corporate perspective. He stated: "The autoimmune disease field is a core strategic priority for ImmuneOnco. As a proprietary bispecific fusion protein, IMC-002 embodies our aspiration to transform the current treatment landscape. Seeing experts from over 40 core clinical research centers gathered here today to discuss this clinical study is truly inspiring. The Company is fully committed to providing comprehensive support to ensure the high-quality advancement of this research, and we aim to deliver a more breakthrough therapeutic option for patients with active SLE in the near future."


Building upon the identified clinical needs and strategic direction, Dr. Wu Zhuli provided an in-depth explanation of IMC-002's scientific mechanism and clinical development pathway: "The unique molecular design of IMC-002 enables the synergistic activation of both ADCC and ADCP effector functions, thereby achieving highly efficient and profound depletion of pathogenic B cells. Based on robust preliminary data, we have initiated this Phase II study. The intravenous (IV) cohort will primarily evaluate two dose levels of 1.2 mg/kg and 1.6 mg/kg to further validate efficacy and determine the recommended Phase III dose (RP3D). Concurrently, we will explore the safety and pharmacokinetic (PK) profile of the subcutaneous (SC) formulation, IMM0306S, to provide patients with more diverse dosing options."


About the IMC-002-S-01 Study

The Phase II study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of IMC-002 in patients with active systemic lupus erythematosus. The primary endpoints for the Phase II portion include assessing the percentage of participants achieving SRI-4 at Week 24 and determining the RP3D.


About ImmuneOnco’s Broad Clinical Development Strategy

Beyond its focus on active SLE, ImmuneOnco is actively advancing the broad clinical development of IMC-002 (IMM0306) across multiple autoimmune indications. According to the latest clinical development plan, a Phase II/III clinical study for IgG4-related disease (IgG4-RD) is steadily progressing. Additionally, Investigational New Drug (IND) applications for membranous nephropathy (MN) and primary Sjögren's syndrome (pSS) have been approved in China, with Phase II trials set to commence shortly. Meanwhile, the clinical development of the subcutaneous formulation of IMM0306 is advancing, which is expected to further enhance long-term medication adherence and improve the treatment experience for patients. On the international front, the Company's IND application for a Phase I clinical trial of IMC-002 in SLE is currently under review by the U.S. Food and Drug Administration (FDA), demonstrating the Company's commitment to a global development strategy.