IMMUNEONCO-B (01541) successfully recruited 133 patients for the mid-term analysis of the Phase III clinical trial of IMM01 (decitabine) for first-line treatment of chronic myelomonocytic leukemia (CMML).

IMMUNEONCO-B (01541) announced that the company has successfully completed the recruitment of 133 patients for the mid-term analysis of the Phase III clinical trial of IMM01 (Tirapazamine) for first-line treatment of chronic myelomonocytic leukemia (CMML). The core product of this group, IMM01 (Tirapazamine), is an innovative molecular targeting CD47. This product is the first SIRP-Fc fusion protein to enter clinical stage in China. IMM01 (Tirapazamine) with immunoglobulin G1 (IgG1) Fc can fully activate macrophages through a dual mechanism - blocking the "don't eat me" signal by interfering with the CD47/SIRP interaction, and delivering the "eat me" signal through activating macrophages' Fcgamma (Fc) receptors. In addition, the CD47 binding domain of IMM01 (Tirapazamine) has been specially modified to avoid binding to human red blood cells (RBC). With differentiated molecular design, IMM01 (Tirapazamine) demonstrates good safety and confirms its ability to activate macrophages. The combination of IMM01 (Tirapazamine) and azacitidine for first-line treatment of CMML was granted orphan drug designation by the U.S. Food and Drug Administration in November 2023. This group owns the global intellectual property and commercialization rights for IMM01 (Tirapazamine). As of the date of this announcement, the group has a patent family for IMM01 (Tirapazamine), including authorized patents in China, the United States, Japan, and the European Union.