On July 3, 2024, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as "ImmuneOnco"“the company’, Hong Kong Stock Exchange stock code: 01541.HK) announced that Timdarpacept (IMM01) combined with Tislelizumab for refractory cHL Phase III clinical trial successfully completed the first patient enrollment on July 1, 2024.

IMM01 is the first SIRP-α-FC fusion protein to enter the clinical stage in China and is developed to use in combination with other drugs to treat a variety of blood and solid tumors. The results of two Phase II clinical trials of IMM01 were released in oral presentations at the American Society of Clinical Oncology (ASCO) 2024 annual meeting.  One is the new updated data of Phase II trial for IMM01 combined with Tislelizumab in cHL patients who have failed prior PD-(L)1 antibody therapy, after 6.87 months of follow-up, ORR reached 66.7%, CR 24.2%, DCR 93.9%, median PFS and median DOR were not reached. In addition, IMM01 combined with Tislelizumab was well tolerated. Another is the phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). After 12.8 months follow-up, ORR reached 64.7%, including 29.4% CR), 15.7% mCR with hematologic improvement (HI): 5.9% HI and 13.7% mCR alone. 12-month PFS reached 54.4%. The updated data show that MM01 combined with AZA were well tolerated and effective in patients with treatment-naive higher-risk MDS.

 Founder and chairman of ImmuneOnco

Dr. Tian, Wenzhi said:

"We are very pleased to see the completion of the first patient enrollment in our Phase III registration clinical trial of Timdarpacept (IMM01) combined with Tislelizumab for cHL refractory to PD-(L)1 monoclonal antibody. This therapy tries to meet ’unmet clinical need’ since there is very limit treatment options for those young-age onset patients. Timdarpacept activates macrophages to turn "cold tumors" into "hot tumors", and macrophages will present more tumor antigens to T lymphocytes to induce tumor-specific T cell responses, thereby restoring and expanding the sensitivity and therapeutic response to Tislelizumab This is well supported by our 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 Tislelizumab for refractory cHL will have great market competitiveness. We will quickly advance the phase III registered clinical trial and strive to bring benefits to cHL cancer patients as soon as possible."

Chief Medical Officer/Senior Vice President of ImmuneOnco, Dr. Lu, Qiying, said:

"the project of IMM01, the company's key product, combined with Tislelizumab successfully completed the enrollment of the first patient in phase III clinical trial for the cHL patients refractory to PD1/PD-L1 therapy. this is another important milestone indicating that the clinical development of IMM01 has fully entered the registered clinical trial stage. This is globally first registration of trial large molecule drug against CD47 for cHL. From approval of CDE on May 16 to First Patient in on July 1, our team took one and half month to get the work done , indicating that the team had strong execution ability and worked efficiently. We are confident that we can quickly promote the clinical development of IMM01 products to bring new treatment options for cancer patients to solve the unmet clinical needs."