ImmuneOnco (1541) Announces Phase III Clinical Trial Enrollment Progress for Timdarpacept

Bulletin Express01-21

ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (1541) reported that 104 patients had been enrolled by December 31, 2025, in the Phase III trial of IMM01 (Timdarpacept) as a first-line treatment for chronic myelomonocytic leukemia (CMML). The trial aims to enroll 132 patients by the end of March 2026 for an interim analysis.

According to the company, business operations and clinical development remain normal, with no material adverse changes to overall operations or the financial position. Timdarpacept (IMM01), an innovative molecule targeting CD47, was designed with immunoglobulin G1 Fc to both block the “don’t eat me” signal by disrupting the CD47/SIRPα interaction and deliver an “eat me” signal through engaging Fc-gamma receptors on macrophages. It is specifically engineered to avoid red blood cell binding and has received orphan-drug designation in the United States for first-line CMML treatment.

The company owns all global intellectual property and commercial rights related to Timdarpacept, with issued patents in China, the United States, Japan, and the European Union. The company cannot guarantee that Timdarpacept will ultimately succeed in development or commercialization, but it continues to pursue clinical progress within the expected timelines.

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