Akeso, Inc. (AKESF) reported that its CD47-targeting antibody Ligufalimab achieved meaningful survival and response improvements in treatment-naïve acute myeloid leukemia (AML), based on Phase II data presented during an oral session at the 2026 European Hematology Association (EHA) Congress.
Akeso is developing Ligufalimab, a next-generation humanized IgG4 anti-CD47 monoclonal antibody, as part of a combination regimen with azacitidine (AZA) and venetoclax (VEN) for AML patients who are not eligible for intensive chemotherapy.
Survival Benefits Observed in Phase II Study
The randomized, double-blind, placebo-controlled Phase II trial (AK117-206) showed a median event-free survival of 9.1 months for Ligufalimab combination versus 6.9 months for the control arm, corresponding to hazard ratio of 0.46, indicating a favorable trend toward reduced risk of disease progression or death.
Six-month EFS rates were 67.8% for the Ligufalimab group compared with 55.5% for control, while nine-month EFS rates were 53.2% versus 14.2% respectively.Median overall survival was not reached in the Ligufalimab arm, compared with 8.3 months in the control group (HR = 0.46). Six-month OS was 83.3% versus 73.2%, and nine-month OS was 78.7% versus 43.1%.
Deep and Durable Responses
The combination produced an objective response rate (ORR) of 80%, compared with 66.7% in the control arm. Composite complete response (CRc) rates were 56.7% versus 53.3%, with a higher proportion of patients achieving minimal residual disease (MRD)-negative CRc in the Ligufalimab group (46.7% vs. 36.7%).
The median duration of CRc was 10.4 months, nearly double the 5.6 months observed in the control arm.
Safety Profile Consistent With Standard AML Therapy
Treatment-emergent adverse events (TEAEs) and serious adverse events occurred at similar rates across both study arms, with no new safety signals identified.The most common TEAEs aligned with expectations for AML patients receiving Azacitidine and Venetoclax. Amemia occurred in 46.7% of patients in the Ligufalimab arms versus 50% in the control arm.
Advancing a Broad CD47 Development Strategy
Ligufalimab has received Orphan Drug Designation (ODD) from the U.S. FDA for AML and is also the first anti-CD47 monoclonal antibody worldwide to enter a registrational Phase III clinical trial in solid tumors, reflecting Akeso's broader development ambitions across hematologic and solid malignancies.
Akeso stated it is progressing its Ligufalimab program at a "globally competitive pace," with multiple studies underway across cancer types.
AKESF has traded between $11.00 and $23.15 over the past year. The stock closed Tuesday's trading at $11.50, down 2.31%.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.