Drug intelligence / Profile preview

FPI-2068

Development stage
Phase 1
Lead developer
AstraZeneca
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules, Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

FPI-2068 is a novel targeted alpha therapy (TAT) radioimmunoconjugate designed to treat various solid tumors that co-express epidermal growth factor receptor (EGFR) and mesenchymal–epithelial transition factor (cMET). It consists of a bispecific antibody targeting both EGFR and cMET conjugated to the alpha-emitting radioisotope actinium-225 via a fast-clear linker. The drug delivers potent ionizing alpha radiation directly into tumor cells expressing these targets, causing double-strand DNA breaks and subsequent activation of DNA damage response pathways leading to apoptosis. This approach aims to maximize anti-tumor efficacy while minimizing off-target toxicity. FPI-2068 is being developed by Fusion Pharmaceuticals (a subsidiary of AstraZeneca) and AstraZeneca for the treatment of advanced solid tumors including metastatic colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, and pancreatic ductal adenocarcinoma[1][3][4][5][6].

Other names
Ac-FPI-2068Ac-FPI2068Ac-FPI 2068225Ac-FPI-2068
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)MET (Mesenchymal-epithelial transition factor receptor)

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