Drug intelligence / Profile preview

OS003

Development stage
Preclinical
Lead developer
OmniSpirant
Modality
Gene Therapies, Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Administration
Intravenous
01

Overview

**OS003** is a preclinical **TP53-based gene therapy** developed by **Omnispirant Ltd.** (also referred to as OmniSpirant Therapeutics) utilizing proprietary **OmniSomes** exosome technology for targeted, non-immunogenic delivery of tumor suppressor RNA payloads. It restores p53 function in cancer cells harboring **TP53** mutations, a key tumor suppressor frequently inactivated in cancers, thereby halting tumor growth more effectively and safely than traditional treatments by leveraging the body's natural RNA transport system. Primarily indicated for **TP53-mutated orphan cancers** with plans for expansion to other mutation-driven cancers via systemic intravenous administration; preclinical data show promising efficacy, including 80% tumor reduction in models, with funding from a €13.4M Horizon Europe grant supporting progression to clinical trials within 24 months targeting pan-cancer applications.[1][3][7][11]

02

Targets

TP53 (Cellular Tumor Antigen p53 R175H)

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