Drug intelligence / Profile preview

MVC-101 + nivolumab

Development stage
Preclinical
Lead developer
Takeda
Modality
T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Intravenous, Intratumoral
01

Overview

MVC-101 + nivolumab is an investigational combination therapy for cancer, particularly for advanced or metastatic solid tumors, including metastatic microsatellite stable colorectal cancer. **MVC-101** (also known as TAK-186) is a conditionally active, protease-activated T cell engager—an engineered protein designed to redirect T cells to kill tumor cells by engaging both T cells (via CD3) and tumor targets (especially EGFR) following proteolytic activation in the tumor microenvironment[2][4]. **Nivolumab** is a fully human IgG4 monoclonal antibody targeting the *programmed cell death protein 1* (PD-1) receptor, blocking immune checkpoint signaling and thereby enhancing T cell-mediated anti-tumor immunity[3]. The combination aims to augment the immune-mediated destruction of tumor cells by enhancing both T cell engagement in the tumor and checkpoint inhibition. Early trials have explored intratumoral microdosing and intravenous administration for a range of solid tumors[3][4]. Historic combination examples (HDAC inhibitor + nivolumab) cover related mechanistic rationales but are not mechanisms of MVC-101[1].

02

Targets

CD3 (T-cell surface glycoprotein CD3)EGFR (Epidermal growth factor receptor)PDCD1 (Programmed cell death protein 1 receptor)

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