ImmuneOnco started Phase Ib/II Clinical Study of IMM01: An IMM01 combined with azacitidine clinical trial completed the first patient enrollment and dosing
On June 21, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" and the company) announced that SIRPaFc recombinant protein targeting human CD47 ，IMM01， combined with azacitidine (AZA) in the treatment of relapsed and refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) Phase Ib/II clinical study (clinical research project number: IMM01-02), completed the first patient enrollment for first dosing. The infusion process went smoothly. The subject is a 25-year-old female AML patient with disease progression after prior chemotherapy.
The IMM01-02 clinical trial project was launched simultaneously in more than 20 hospitals across the country to evaluate the safety and efficacy of IMM01 in combination with AZA for AML and MDS indications.
Dr. Tian Wenzhi , Founder, Chairman and CEO of ImmuneOnco, feels confident in clinical trial research of IMM01.
"I am very pleased to know that our IMM01 combined with azacitidine for relapsed and refractory AML and MDS indications has completed the first patient enrollment and dosing. Due to the unique design of the molecular structure, IMM01 does not bind to erythrocytes and prevent it from causing RBC clogs and severe anemia. what is more, due to the glycosylation of Fc modification, the immunogenicity of the drug is greatly reduced, so that the PK and the bioavailability of the drug is significantly improved. So far, based on preliminary data, 1 complete remission (CR), 2 partial remissions (PR), and 8 stable disease (SD) occurred in different dose groups in open-labeled IMM01 mono-drug therapy trials.”
"We will work closely with clinical experts and subjects to accelerate the clinical trial research of IMM01 and step the pace faster to launch IMM01 market available to benefit relapsed and refractory cancer."