Company News

ImmuneOnco Announces Phase III Study of timdarpacept (IMM01) in CMML Reaches Interim Analysis Milestone with 133 Subjects Enrolled
2026-03-23
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Shanghai, China, March 23, 2026 — ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (“ImmuneOnco,” HKEX Stock Code: 01541.HK) today announced a major milestone in its pivotal Phase III clinical study of its core proprietary product, timdarpacept (IMM01), for the treatment of Chronic Myelomonocytic Leukemia (CMML). As of late March 2026, the study has cumulatively enrolled 133 subjects, successfully reaching the prespecified milestone of 132 subjects required for interim analysis.


According to the statistical hypothesis, once the data mature, the Independent Data Monitoring Committee (IDMC) will conduct a blinded interim analysis of the accumulated data, with a focus on evaluating the Complete Response (CR) rate and key secondary endpoints. If the interim analysis results meet the prespecified statistical superiority boundary, the Company plans to formally submit a pre-Biological License Application (pre-BLA) by the end of 2026.


The Company will maintain close communication with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), strictly adhere to relevant regulatory requirements to advance the registration process, and is committed to accelerating the availability of this therapy to CMML patients.


Dr. Tian Wenzhi, Founder, Chairman, CEO, and CSO of ImmuneOnco, stated:

“The successful enrollment of 132 patients required for interim data analysis in the Phase III study of timdarpacept (IMM01) for CMML marks a critical step in the product’s commercialization journey. We look forward to the upcoming interim analysis data further confirming the breakthrough efficacy of timdarpacept. Should the data be positive, we will go all out to strive for the submission of the pre-BLA by the end of 2026, aiming to bring the first specific targeted therapy to CMML patients in China and globally at the earliest possible time.”


Ms. Wu Zhuli, Chief Medical Officer of ImmuneOnco, stated:

“The unique dual mechanism of action of timdarpacept (IMM01) enables potent clearance of tumor cells while maintaining a favorable safety profile, which is crucial for CMML patients requiring long-term treatment. With the early completion of the enrollment target, our clinical team across all functions will work closely together to ensure high-quality data collection and analysis. We will continue to advance towards the second key milestone of enrolling 170 subjects by July 2026, while preparing for the subsequent interim analysis and pre-BLA submission, to provide an efficient and safe treatment option for patients as soon as possible.”