China-based Akeso Biopharma (HKG: 9926) has reached a clinical milestone with the dosing of the first patient in a Phase II study for its investigational drug ligufalimab (AK117) in the United States. The study is a randomized, placebo-controlled, global multi-center trial that combines ligufalimab with azacitidine for the treatment of patients with initially diagnosed high-risk myelodysplastic syndrome (MDS).
Previously, ligufalimab, an anti-CD47 monoclonal antibody developed in-house, has demonstrated a favorable safety profile in MDS studies and has shown potential in improving hematological indicators in the majority of MDS patients. The drug’s mechanism of action targets the CD47 protein, which is known to play a role in tumor evasion of the immune system.
In addition to the MDS trial, ligufalimab is also being evaluated in a separate Phase II study for first-line acute myeloid leukemia (AML) patients who are not suitable candidates for intensive chemotherapy. This underscores Akeso Biopharma’s commitment to advancing novel therapies for blood-related cancers.- Flcube.com