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

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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

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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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