NK Cytokine Therapy
Ceplene® (HDC) is a NOX2 inhibitor which functions in AML by reducing the immunosuppressive effects of reactive oxygen species on T-cells and NK cells, permitting their effective activation by aldesleukin or interleukin-2 (“IL-2”) to eliminate residual leukemic cells in patients who are in clinical complete remission.
In a recent 320-patient international phase III clinical trial, Ceplene has demonstrated an improvement of over 50% in Leukemia Free Survival at 3 years. New clinical data has confirmed anti-leukemic activity through Minimal Residual Disease (MRD) monitoring, as well as the relevance of a precision medicine approach including genetic patient selection (Normal Karyotype/ NPM1) and monitoring of immune bio-markers - such as NK cell activation - to predict survival in patients treated with Ceplene.
Ceplene was approved in 2018 by the European Medicine Agency for the prevention of relapse in AML patients in first complete remission. A prospective confirmatory AML clinical trial is expected to be initiated in 2020 to support approval in the United States.
New indications being explored through Investigator Sponsored Studies include Chronic Myelogenous Leukemia (CML), Chronic Myelo-Monocytic Leukemia (CMML), combination with check point inhibitors in solid tumors, and metastasis prevention in pancreatic cancer.