ADGN-531

ADGN-531 is an investigational mRNA-based therapeutic designed to restore wild-type p53 tumor suppressor function in cancer cells with p53 mutations or deletions. The drug consists of full-length p53 mRNA encapsulated in proprietary, tumor-targeted peptide nanoparticles (non-lipid nanoparticle formulation). By delivering functional p53 mRNA into cancer cells, ADGN-531 enables the re-expression of wild-type p53 protein, leading to significant inhibition of tumor cell growth and induction of apoptosis. Preclinical studies have demonstrated that ADGN-531 markedly inhibits the growth of a wide range of cancer cell lines harboring various types of p53 mutations (null, deletion, nonsense, and missense) and shows dose-responsive tumor growth inhibition in animal models for osteosarcoma, ovarian cancer, colorectal cancer (SW403), lung cancer (SaOs2), and others. The treatment is well tolerated with no observed clinical toxicity or inflammatory reactions in preclinical models. Developed by Aanastra Inc. and Divincell SAS., its primary indication is for neoplasms characterized by loss-of-function mutations in TP53[1][6][7][8].