This is a First-in-Human, single arm, open-label, multi-national study designed to determine the safety, tolerability and preliminary efficacy of MCLA 117.

Start Date01 Apr 2016

Sponsor / Collaborator

Merus NV

100 Clinical Results associated with Tepoditamab

100 Translational Medicine associated with Tepoditamab

100 Patents (Medical) associated with Tepoditamab

Literatures (Medical) associated with Tepoditamab

03 Jul 2019·Expert Opinion on Biological TherapyQ3 · MEDICINE

MCLA-117, a CLEC12AxCD3 bispecific antibody targeting a leukaemic stem cell antigen, induces T cell-mediated AML blast lysis

Q3 · MEDICINE

Article

Author: Logtenberg, Ton ; Hendriks, Linda J. A. ; de Kruif, John ; Gibbins, John D. ; Leenders, Marij ; Hangalapura, Basav N. ; Dolstra, Harry ; Thordardottir, Soley ; van Loo, Pieter Fokko ; Bakker, Alexander B. H. ; Roovers, Rob C. ; Throsby, Mark ; Veninga, Henrike ; Sirulnik, Andres ; Kramer, Arjen ; Doornbos, Robert P.

Objective: We report the characterization of MCLA-117, a novel T cell-redirecting antibody for acute myeloid leukaemia (AML) treatment targeting CD3 on T cells and CLEC12A on leukaemic cells. In AML, CLEC12A is expressed on blasts and leukaemic stem cells. Methods: The functional capacity of MCLA-117 to redirect resting T cells to eradicate CLEC12A^POS tumor cells was studied using human samples, including primary AML samples. Results: Within the normal hematopoietic compartment, MCLA-117 binds to cells expressing CD3 and CLEC12A but not to early myeloid progenitors or hematopoietic stem cells. MCLA-117 induces T cell activation (EC₅₀ = 44 ng/mL), T cell proliferation, mild pro-inflammatory cytokine release, and redirects T cells to lyse CLEC12A^POS target cells (EC₅₀ = 68 ng/mL). MCLA-117-induced targeting of normal CD34^POS cells co-cultured with T cells spares erythrocyte and megakaryocyte differentiation as well as preserves mono-myelocytic lineage development. In primary AML patient samples with autologous T cells, MCLA-117 robustly induced AML blast killing (23-98%) at low effector-to-target ratios (1:3-1:97). Conclusion: These findings demonstrate that MCLA-117 efficiently redirects T cells to kill tumour cells while sparing the potential of the bone marrow to develop the full hematological compartment and support further clinical evaluation as a potentially potent treatment option for AML.

100 Deals associated with Tepoditamab

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Promyelocytic Leukemia	Phase 1	France	Merus NV	01 Apr 2016
Acute Promyelocytic Leukemia	Phase 1	Belgium	Merus NV	01 Apr 2016
Acute Promyelocytic Leukemia	Phase 1	United States	Merus NV	01 Apr 2016
Acute Promyelocytic Leukemia	Phase 1	Italy	Merus NV	01 Apr 2016
Acute Promyelocytic Leukemia	Phase 1	Netherlands	Merus NV	01 Apr 2016
Myelodysplastic Syndromes	Phase 1	Netherlands	Merus NV	-

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