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ficerafusp alfa
- Development stage
- Phase 3
- Lead developer
- Bicara Therapeutics
- Modality
- Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Nucleic Acid-Directed Small Molecules → Small Molecules, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Vaccines & Immunotherapeutics
- Administration
- Intravenous
01
Overview
Ficerafusp alfa is a first-in-class, bifunctional recombinant fusion protein developed by Bicara Therapeutics. It is designed to target two clinically validated pathways in cancer—epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β). The molecule consists of an EGFR-directed monoclonal antibody fused with a domain that binds TGF-β, enabling it to simultaneously block EGFR-mediated tumor cell survival/proliferation and neutralize immunosuppressive TGF-β signaling within the tumor microenvironment. This dual mechanism aims to enhance anti-tumor immune responses and improve clinical outcomes in solid tumors, particularly head and neck squamous cell carcinoma (HNSCC). Ficerafusp alfa is administered intravenously and has shown promising efficacy in early-phase clinical trials when combined with pembrolizumab[1][2][4][6].
- Other names
- EGFR/TGFβ fusion monoclonal antibody
02
Targets
EGFR T790M (Epidermal growth factor receptor T790M mutant)TGFB1 (Transforming growth factor Beta-1 proprotein)
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