IMM01 (SIRPα-Fc Fusion Protein)

IMM01, our Core Product, is an innovative CD47-targeted molecule. It is the first SIRPα-Fc fusion protein to enter into clinical stage in China. IMM01 designed with IgG1 Fc can fully activate macrophages via a dual mechanism — simultaneously blocking the “don’t eat me” signal by disrupting CD47/ SIRPα interaction and delivering the “eat me” signal through the engagement of activating Fcγ receptors on macrophages. Furthermore, the CD47-binding

domain of IMM01 was specifically engineered to avoid human red blood cell (RBC) binding. With the differentiated molecule design, IMM01 has achieved a favorable safety profile and demonstrated its ability to activate macrophages. Moving forward, we may actively explore IMM01’s therapeutic potential in other indications and seek collaboration opportunities.

Combination Therapy with Tislelizumab

◆ We had dosed the first patient for the Phase II clinical trial of IMM01 in combination with tislelizumab on January 19, 2023, targeting R/R cHL patients who relapsed or progressed after the treatment of PD-1 inhibitors, and completed the Phase II enrollment in December 2023. As of June 30, 2024, 33 cHL R/R patients were enrolled. Among 33 efficacy evaluable patients, 8 achieved CR, 14 achieved PR, resulting in an ORR of 66.7% and CRR of 24.2%, respectively. There was no reported hemolytic anemia or hemolysis in any of the patients. No patients experienced TRAEs leading to the study drug discontinuation or death. These results demonstrate encouraging antitumor efficacy, along with favorable tolerability and safety profiles.

◆ We expect to complete the Phase II clinical trial in 2024. We received approval from the NMPA for the protocol of the Phase III clinical trial of IMM01 in combination with tislelizumab versus physician’s choice chemotherapy in prior PD-(L) 1-refractory cHL in April 2024. The first patient in reached on July 1, 2024 in this phase III study.