Drug intelligence / Profile preview

M5A-IL2

Development stage
Phase 1
Lead developer
City of Hope Comprehensive Cancer Center
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Immunomodulatory ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

M5A-IL2 is an immunocytokine, a recombinant fusion protein that combines the tumor-targeting properties of the humanized anti-carcinoembryonic antigen (CEA; CEACAM5) monoclonal antibody (M5A) with the immune-stimulating activity of human interleukin 2 (IL‑2). The fusion is achieved by attaching IL‑2 to the C-terminal end of the heavy chain of the M5A antibody. This design enables selective delivery of IL‑2 to CEA-expressing tumor cells, thereby enhancing local immune activation and potentially reducing systemic toxicity. The mechanism involves targeting CEA-positive tumors—such as colorectal and breast cancers—and stimulating an anti-tumor immune response through activation and proliferation of T cells and natural killer cells at the tumor site. Preclinical studies have shown potent antitumor effects in models expressing human CEA, including induction of immune memory when combined with radiation therapy. Clinical trials are ongoing for unresectable metastatic colorectal cancer and CEA-positive metastatic breast cancer[1][4][5].

Other names
m5a-il2m-5a-il2m 5a-il2
02

Targets

CEACAM5 (Carcinoembryonic antigen related cell adhesion molecule 5)IL-2R (Interleukin-2/interleukin-15 receptor complex)

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