Scientific Technology and R&D

IMM01 + Azacitidine

ImmuneOnco is evaluating the combination of IMM01 and azacitidine for the first-line treatment of HR MDS, unfit AML, and CMML. Upon completion of the Phase Ib trial, we initiated a Phase II cohort expansion trial of IMM01 and azacitidine mainly for the first-line treatment of HR MDS, unfit AML and CMML in China in June 2022. Particularly, we plan to seek an accelerated marketing approval through relatively small sample size studies targeting the first-line treatment of CMML, a rare type of disease with highly unmet medical needs.

As validated by multiple publicly reported clinical trials, the combination of CD47-targeted therapies and azacitidine can generate synergistic tumor-killing effects. However, since azacytidine also induces blood toxicity, its combination with CD47 antibodies (which also cause blood toxicity) may lead to exacerbated blood toxicity and serious safety issues. In contrast, based on the initial data from our ongoing Phase Ib/II clinical trial, IMM01 presents strong potential to be a combination partner with azacitidine because of its dual mechanisms and favorable safety profile.