IMMUNEONCO-B (01541) Completes Enrollment of 133 Patients for Interim Analysis in Phase III Trial of IMM01 (Tidapaxic) as First-Line Treatment for Chronic Myelomonocytic Leukemia

Stock News
03/23

IMMUNEONCO-B (01541) announced the successful completion of patient recruitment for the interim analysis of its Phase III clinical trial evaluating IMM01 (Tidapaxic) as a first-line treatment for chronic myelomonocytic leukemia (CMML), with 133 participants enrolled. The group's core product, IMM01 (Tidapaxic), is an innovative molecule targeting CD47. It is the first SIRPα-Fc fusion protein in China to enter the clinical stage. IMM01 (Tidapaxic), which features an immunoglobulin G1 (IgG1) Fc, activates macrophages through a dual mechanism of action—simultaneously blocking the "don't eat me" signal by interfering with CD47/SIRPα interactions and transmitting an "eat me" signal by activating the macrophage's Fcgamma (Fcγ) receptor. Additionally, the CD47-binding domain of IMM01 (Tidapaxic) has been specifically engineered to avoid binding with human red blood cells (RBCs). Due to its differentiated molecular design, IMM01 (Tidapaxic) demonstrates a favorable safety profile and has proven effective in activating macrophages. In November 2023, the combination of IMM01 (Tidapaxic) with azacitidine for first-line CMML treatment received orphan drug designation from the U.S. Food and Drug Administration. The group holds global intellectual property and commercialization rights for IMM01 (Tidapaxic). As of the date of this announcement, the group possesses one patent family for IMM01 (Tidapaxic), including granted patents in China, the United States, Japan, and the European Union.

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