On April 7, 2024, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco"“the company’, Hong Kong Stock Exchange stock code: 01541.HK) , announced that five innovative drug studies were accepted by the American Society of Clinical Oncology (ASCO) Annual Meeting in 2024, in which, they will be reported to global attendees in the form of oral presentations, posters and online publications. It covers the latest clinical progress of IMM01(SIRP-IGG1 Fc), IMM0306 (CD47xCD20 mAb-Trap) and IMM2510 (VEGFxPD-L1 mAb-Trap).

Two innovative clinical phase II studies of IMM01 were included in the oral reports (IMM01 combined with Tirelizumab for cHL indications after previous PD1 antibody treatment failure, and IMM01 combined with azacitide for high-risk MDS indications for initial treatment). A preliminary phase I clinical study of IMM0306 in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL) is presented in the form of poster. The results of the other two studies were presented in the form of online publication (the clinical phase Ib study of IMM0306 combined with lenalidomide in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL), and the clinical phase I dose-climbing study of lMM2510 monotherapy in the treatment of advanced solid tumors).

Founder and chairman of ImmuneOnco

Dr. Tian, Wenzhi said:

"The findings we will present at ASCO 2024 will help inform the industry about the latest clinical development data for IMM01, IMM0306, and IMM2510." IMM01 is the first SIRP-α-FC fusion protein to enter the clinical stage in China being developed to use in combination with other drugs to treat a variety of blood tumors and solid tumors. Based on the initial effectiveness and good safety in clinical trials of monotherapy, as well as the clinical research data of IMM01 in clinical phase II treatment of cHL and MDS patients presented at the ASCO annual meeting, it will again prove that the differentiated molecular design of IMM01 perfectly solves the clinical safety problems commonly faced by CD47 antibody drug candidates. Our IMM01 has great potential to become the world's first approved CD47-targeting drug. IMM0306 is another CD47-targeted macromolecule that has shown encouraging efficacy and a good safety profile in Phase I clinical studies in relapsed or refractory B-cell lymphomas. The Phase II clinical study of IMM0306 combined with lenalidomide is rapidly progressing, and the initial clinical performance is quite exciting. We believe that the differentiated molecular design of CD47-targeted drugs will be a key determinant of success in clinical development. IMM2510 is a bispecific molecule targeting VEGF and PD-L1, and has shown positive therapeutic signals against advanced non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma) and thymic carcinoma. We are pleased to have the opportunity to share these data with our oncology colleagues and look forward to further releases of clinical data from IMM01, IMM0306, and IMM2510."

Chief Medical Officer/Senior Vice President of ImmuneOnco

Dr. Lu, Qiying said:

"Following the preliminary clinical phase II data disclosed in ASH last year, the results of two clinical phase II studies on IMM01 products were recognized and affirmed by the academic community at ASCO this year, and were accepted as oral reports by ASCO 2024; In addition, one research result of IMM0306 was displayed as a poster, and two research results were published online (clinical phase Ib results of IMM0306 combined with LEN and clinical phase I results of IMM2510). IMM01 is the company's key product and one of the important cornerstones of our company in the field of  tumor immunotherapy. In terms of clinical development layout of IMM01 products, we have carried out a differentiated tactics. For newly treated CMML patients, IMM01-02 is currently a prospective clinical study with the largest sample size for this rare tumor to meet the unmet medical needs. In view of the unmet medical needs of cHL after previous PD-1 failure, our combined treatment model can overcome the drug resistance of previous PD1 antibody therapy, and reflects the advantages of chemotherapy therapy, avoiding the long-term toxicity brought by chemotherapy drugs and bringing long-term quality of life to patients. Encouraging efficacy and good tolerability have been observed in initially treated high-risk MDS patients, initially treated CMML patients, and cHL patients after previous PD-1 antibody therapy failure. As one of the company's key products, IMM0306 monotherapy was observed in a number of indications, outstanding initial efficacy (including FL and MZL mainly inert lymphoma and the most common clinical aggressive lymphoma DLBCL), indicating that this product has broad clinical development prospects. IMM2510 showed initial positive therapeutic signals in relapsed and refractory non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma) and thymus cancer in the climbing study. In particular, one patient with lung squamous cell carcinoma obtained significant tumor shrinkage (PR) after the failure of PD-1 antibody therapy and combination chemotherapy, and the PR lasted more than 11 months. It has been receiving the investigational drug for more than 20 months and the treatment is still undergoing. In light of unmet clinical needs, we plan to further develop a single agent and a combination of different treatment modalities for multiple indications to explore efficacy in multiple solid tumors, including non-small cell lung cancer, triple negative breast cancer, and liver cancer in addition to soft tissue sarcomas. We look forward to rapidly advancing the clinical development of IMM01, IMM0306 and IMM2510 products, bringing new treatment options for the treatment of cancer patients and addressing unmet clinical needs."