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AAN-53x is an investigational RNA-based therapeutic developed by Aanastra for the *in vivo* restoration of tumor suppressor p53 (TP53) function in cancer cells with p53 mutations. Utilizing Aanastra’s proprietary PEP-NP peptide-targeted RNA delivery platform, AAN-53x delivers mRNA that rescues or restores wild-type p53 activity directly within p53-mutant tumors, aiming to address the broad spectrum of p53 mutations found in more than 50% of human cancers. Preclinical data presented in 2025 demonstrate remarkable tumor regressions across a wide range of p53-mutated tumor models, showing the therapeutic’s potential to impact aggressive and treatment-resistant cancer subtypes for which no currently approved p53-restoring therapy exists. The PEP-NP platform is distinct in that it avoids lipid, viral, or protein components, and can achieve effective repeat dosing without immunogenicity or hepatic toxicity, bypassing the limitations of traditional RNA delivery systems. The drug is currently in preclinical development.
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