The phase II clinical study of ImmuneOnco’s IMM01 combined with azacitidine for first line treatment of high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) completed the enrollment of patients

    On December 26, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") announced completion of patient enrollment for a phase II clinical trial. The study is IMM01, the first SIRPα-Fc fusion protein drug targeting human CD47 in China, combined with azacitidine (AZA) as first line treatment of high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

Dr. Tian, Wenzhi, founder and chairman of ImmuneOnco, is fully confident in the clinical trial of IMM01:

    "I am very pleased to know that IMM01 combined with azacitidine complete the enrollment of patients in Phase II clinical trials for first line treatment of high-risk MDS and AML. Due to the differentiated design of the molecule, IMM01 does not bind to red blood cells at all in the in vitro experiments so to overcome major obstacle of severe anemia events.  Glycosylation modification of IMM01 molecules greatly reduces the immunogenicity, the bioavailability demonstrated by the PK is also significantly improved. Therefore, it showed excellent safety profiles and efficacy in the phase I dose escalation study. In the mono treatment of IMM01, 2 complete remission (CR) and 1 partial remission (PR) occurred in patients with lymphoma who had undergone multiple line treatments. One of the patients has been in long-term remission for more than 26 months. It is also encouraging that, in Phase II study, complete remission was observed in the newly diagnosed AML and MDS patients, which is expected to bring the opportunity of long-term survival to patients."

    "We will work closely with clinical experts and patient as well to accelerate the clinical research of IMM01 and benefit cancer patients as soon as possible."

Dr. Lu, Qiying, Chief Medical Officer/Senior Vice President of ImmueOnco, commented:

    "This is an important milestone. IMM01, as company's key product, is highly expected and prioritized by our team. IMM01-02 study is one of phase 2 clinical studies of IMM01 which combined with AZA for newly diagnosed AML and MDS. The enrollment started on June 29 and completed today in just a few months. As one of the important cornerstones of the company's IO treatment, IMM01 has entered phase II clinical development for multiple indications, covering hematological tumors and solid tumors, by involving different drug combinations (including AZA, PD1 antibody and other drugs). Our clinical development in multiple indications fully reflects our differentiated layout. Exciting efficacy as well as safety profiles were observed in both single and combined AZA agents. The company will accelerate the clinical development of this product and look forward to bringing new options for oncology treatment and addressing unmet clinical needs."