Drug intelligence / Profile preview

FP008

Development stage
Phase 1
Lead developer
Guangdong Fapon Biopharma
Modality
Immunomodulatory ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

FP008 is a first-in-class biologic immunocytokine developed by Fapon Biopharma for the treatment of solid tumors, particularly in patients who are refractory or resistant to anti-PD-1 therapies. It is a bifunctional fusion protein that combines an engineered interleukin-10 monomer (IL-10M) with an anti-PD-1 antibody. The IL-10M component is designed to reduce the hematologic toxicity associated with wild-type IL-10, while the anti-PD-1 antibody targets and enriches the drug at PD-1 expressing sites, enabling cis activation of IL-10M. Mechanistically, FP008 counteracts CD8+ T cell exhaustion induced by prolonged PD-1 blockade, restores their functional activity, and increases their infiltration into tumor microenvironments—resulting in enhanced anti-tumor effects as demonstrated in preclinical models. The drug has shown good tolerability and pharmacokinetics in non-human primate studies[1][2][3][4][5].

Other names
FP-008FP008FP 008
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)IL10RA (Interleukin-10 Receptor)

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