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Phase III clinical study of Timdarpacept combined with Tirellizumab for refractory cHL approved by CDE

On April 17, 2024, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as " ImmuneOnco "), HKEX stock code: 01541.HK) announced that the Phase III clinical study protocol of Timdarpacept (R&D number: IMM01) combined with Tirellizumab for PD-1/PD-L1 inhibitor failed Classic Hodgkin lymphoma (cHL) was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.


IMM01 is the first SIRP-α-FC fusion protein to enter the clinical stage in China and is being developed to use in combination with other drugs to treat a variety of blood and solid tumors. Recently, the results of two Phase II clinical innovation studies in IMM01 were included in the oral report of the American Society of Clinical Oncology (ASCO) Annual meeting in 2024 (respectively, IMM01 combined with Tirellizumab in the treatment of cHL indications after previous PD-1 antibody treatment failed, and IMM01 combined with azacitide in the treatment of high-risk MDS indications for initial treatment).


In December 2023, the results of three Phase II clinical innovation studies on IMM01 were selected for oral presentation and poster presentation at the 2023 annual meeting of the American Society of Hematology (ASH), among which two studies were selected for oral presentation in 2023 ASH (cHL indication and 1-line MDS indication after PD-(L)1 antibody treatment failure). The results of another 1-line CMML indication study were presented in poster form. This is the clinical research progress of IMM01 project selected for ASH annual meeting for two consecutive years.

Updated data were reported at the ASH meeting in 2023: The ORR, CR, and DCR of cHL patients treated with IMM01 combined with Tirelizumab after previous PD-(L)1 antibody treatment failure reached 65.2%, 17.4%, and 100%, which shown to benefit from the combination therapy in each subgroup analysis. In addition, IMM01 combined with tirellizumab was well tolerated, and no patients had permanent discontinuation due to drug-related adverse reactions. The Phase II update results received an oral presentation at ASCO 2024 and will be presented in Chicago on June 2.


Founder and chairman of ImmuneOnco

Dr. Tian, Wenzhi said:

"We are very pleased to have received CDE approval for our Phase III registered clinical study protocol for Timdarpacept (IMM01) in combination with Tirellizumab for PD-1/PD-L1 inhibitor failed Classical Hodgkin lymphoma (cHL). Clinical treatment for PD-1/PD-L1 inhibitor treatment failed cHL is an unmet clinical need especially for those patients whose onset age is relatively young. We believe that Timdarpacept through activating macrophages can turn "cold tumors" into "hot tumors", and can induce more tumor-specific T cell responses by presenting tumor antigens to T lymphocytes, thereby restoring and expanding the sensitivity and therapeutic response of patients to tirellizumab. Our scientific judgment is well supported by the obtained clinical data. In contrast, PD-1 antibody combined with another T cell-associated immune checkpoint antibody is difficult to achieve such clinical manifestations. We firmly believe that the development of Timdarpacept  in combination with Tirellizumab against PD-1/PD-L1 monoclonal antibody refractory cHL will have great market competitiveness. We will quickly advance the Phase III registered clinical trial study, and strive to bring benefits to cHL patients as soon as possible."


Chief Medical Officer/Senior Vice President, ImmuneOnco

Dr. Lu, Qiying said:

"Today's CDE approval of IMM01 in combination with Tirellizumab for a refractory cHL indication is an extremely important milestone for our company. The results of two clinical phase II studies on IMM01 products were all recognized and affirmed by ASCO in 2024, and two were accepted as oral reports. In terms of clinical development layout of IMM01 products, we have carried out a differentiated layout. Aiming at the unmet medical demand of cHL after the failure of previous PD-1/PD-L1 antibody treatment, our combined treatment mode can overcome the drug resistance of previous PD-1/PD-L1 antibody treatment, and reflects the advantages of chemotherapy treatment. It can avoid the long-term toxicity caused by chemotherapy drugs and bring long-term quality of life advantages to patients. In addition, the current efficacy data has been further improved compared to the ASH abstract submitted in July last year, with better efficacy response (ORR/CR) for the cHL indication. Today, the phase III clinical registration study was approved by CDE indicating that the clinical development of IMM01 has fully entered the registration study stage, and this is the world's first macromolecule drug to develop cHL registration indications against CD47 targets. At present, our team is well prepared to start the trial. We look forward to rapidly advancing the clinical development of IMM01 products, bringing new therapeutic options to the treatment of cancer patients and addressing unmet clinical needs."