IMMUNEONCO-B (01541) announced the successful completion of patient recruitment for the Phase III clinical trial of IMM01 (Tedaparicep) as a first-line treatment for chronic myelomonocytic leukemia (CMML), enrolling 104 patients as of December 31, 2025. The company anticipates finishing the recruitment of the 132 patients required for an interim analysis by the end of March 2026. As of the date of this announcement, the Board of Directors confirms that the Group's business operations and clinical development activities are proceeding normally, with no significant adverse changes to its operational or financial condition.
The Group's core product, IMM01 (Tedaparicep), is an innovative molecule targeting CD47. This product is the first SIRPα-Fc fusion protein to enter the clinical stage in China. IMM01 (Tedaparicep), 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 delivering an "eat me" signal by activating the macrophage's Fc-gamma (Fcγ) receptor.
Furthermore, the CD47 binding domain of IMM01 (Tedaparicep) has been specifically engineered to avoid binding with human red blood cells (RBCs). Thanks to this differentiated molecular design, IMM01 (Tedaparicep) has demonstrated a favorable safety profile and confirmed its ability to activate macrophages.
The combination therapy of IMM01 (Tedaparicep) with azacitidine for first-line CMML treatment was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) in November 2023. The Group holds the global intellectual property rights and commercialization rights for IMM01 (Tedaparicep).
As of the date of this announcement, for IMM01 (Tedaparicep), the Group possesses one patent family that includes granted patents in China, the United States, Japan, and the European Union.
Comments