Drug intelligence / Profile preview

IAE0972 + methotrexate

Development stage
Phase 3
Lead developer
SUNHO BioPharmaceutical
Modality
Immunomodulatory ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Fc Fusion Proteins → Engineered Antibody Formats → Antibody-Based Therapeutics, Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
Administration
Intravenous, Oral
01

Overview

IAE0972 + methotrexate is an investigational combination therapy for cancer, currently in clinical trials. IAE0972 is a first-in-class immunocytokine developed by Sunho (China) Biopharmaceutical using their proprietary Armed ImmunoCytokine (AIC) platform. It is an antibody fusion protein that combines an anti-EGFR antibody with interleukin-10 (IL10). The anti-EGFR component targets and enriches the drug in EGFR-positive tumor microenvironments, while the IL10 moiety acts as a potent activator of antigen-specific CD8+ T cells, aiming to overcome immune cell exhaustion and restore tumor-killing activity of lymphocytes. This dual mechanism allows for both direct inhibition of tumor cell proliferation via Epidermal growth factor receptor antagonism and immune activation through Interleukin 10 receptor stimulation. Methotrexate, a well-established chemotherapy agent and antimetabolite, is used in combination to enhance antitumor efficacy. The combination has been studied primarily in head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, and other advanced solid tumors[1][3][4][5].

02

Targets

DHFR (Dihydrofolate reductase)EGFR (Epidermal growth factor receptor)IL10RA (Interleukin-10 Receptor)

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