The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion, in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and potential immunogenicity of MEN1112 will be evaluated as well.

Start Date01 Dec 2014

Sponsor / Collaborator

A. Menarini Industrie Farmaceutiche Riunite SRL

100 Clinical Results associated with OBT-357

100 Translational Medicine associated with OBT-357

100 Patents (Medical) associated with OBT-357

Literatures (Medical) associated with OBT-357

30 May 2017·Oncotarget

Targeting CD157 in AML using a novel, Fc-engineered antibody construct

Article

Author: Lichtenegger, Felix S. ; Bisht, Arnima ; Hiddemann, Wolfgang ; Altmann, Torben ; Aud, Dee ; Pombo-Villar, Esteban ; Köhnke, Thomas ; Bögeholz, Jan ; Rohlff, Christian ; Bücklein, Veit ; Wilson, Keith ; Krupka, Christina ; Dusek, Rachel ; Subklewe, Marion ; Roiss, Michael ; Do, To Uyen ; Terrett, Jon

Antibody-based immunotherapy represents a promising strategy to eliminate chemorefractory leukemic cells in acute myeloid leukemia (AML). In this study, we evaluated a novel Fc-engineered antibody against CD157 (MEN1112) for its suitability as immunotherapy in AML. CD157 was expressed in 97% of primary AML patient samples. A significant, albeit lower expression level of CD157 was observed within the compartment of leukemia-initiating cells, which are supposed to be the major source of relapse. In healthy donor bone marrow, CD157 was expressed on CD34+ cells. In ex vivo assays, MEN1112 triggered natural killer (NK) cell-mediated cytotoxicity against AML cell lines and primary AML cells. Compared to its parental analogue, the Fc-engineered antibody exhibited higher antibody dependent cellular cytotoxicity responses. Using NK cells from AML patients, we observed heterogeneous MEN1112-mediated cytotoxicity against AML cells, most likely due to well-documented defects in AML-NK cells and corresponding inter-patient variations in NK cell function. Cytotoxicity could not be correlated to the time after completion of chemotherapy. In summary, we could demonstrate that CD157 is strongly expressed in AML. MEN1112 is a promising antibody construct that showed high cytotoxicity against AML cells and warrants further clinical testing. Due to variability in NK-cell function of AML patients, the time of application during the course of the disease as well as combinatorial strategies might influence treatment results.

100 Deals associated with OBT-357

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory acute myeloid leukemia	Phase 1	FR	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Refractory acute myeloid leukemia	Phase 1	BE	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Refractory acute myeloid leukemia	Phase 1	ES	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Refractory acute myeloid leukemia	Phase 1	DE	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Refractory acute myeloid leukemia	Phase 1	IT	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Relapsing acute myeloid leukemia	Phase 1	DE	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Relapsing acute myeloid leukemia	Phase 1	ES	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Relapsing acute myeloid leukemia	Phase 1	FR	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Relapsing acute myeloid leukemia	Phase 1	BE	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014
Relapsing acute myeloid leukemia	Phase 1	IT	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Dec 2014

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