10181467A Peptide-miRNA Loaded Biomaterial for Wound RepairActiveCollaborative R&DInnovate UKRNA therapies have the potential to transform healthcare interventions, as evidenced by over 30 approvals by the FDA, hundreds of clinical trials using RNA, and the first patient given mRNA therapy in the UK in 2024\. RNA therapies encompass short interfering RNA, microRNA, double-stranded RNA, oligonucleotides, messenger RNA, and self-amplifying RNA. Irrespective of the type, RNA needs to be delivered inside the cell, within the cytoplasm, where it can either express a therapeutic protein or repress a disease-causing protein. For the products approved thus far, Lipid Nanoparticles (LNPs) have been the delivery vehicle of choice. However, cells recognise the LNPs as foreign, which provokes an immune response that is unrelated to the RNA cargo. Additionally, LNPs require cold-chain storage, are solvent based, are restricted by the size and number of RNA they can deliver, and have suboptimal endosomal escape. XapHe, a new Belfast-based SME, has developed a solution for RNA delivery that is safe, does not exacerbate the immune system, enables full escape of the RNA to the cytoplasm of the cell, and allows for multiple administrations. The innovation centres on use of XapHe's peptide to condense RNA into nanoparticles (NPs), enabling cell entry via two mechanisms and resulting in higher bioavailability of the RNA in the cytoplasm. The peptide-RNA NPs can also be stored at room temperature post-lyophilisation. In this project, XapHe's technology will be applied for efficacious treatment of chronic wounds, with therapeutic peptide-microRNAs being released from a biocompatible nanogel (known as Heal-X). that is topically applied. Given that ~£10B of the NHS budget per annum is spent on wound care, with 67% of this managing unhealed wounds, there is a need for innovative solutions. Having demonstrated proof of principle, the key objectives of this project are to gather the data required to give confidence to proceed to clinical trial. Specifically, we aim to: i) streamline the manufacturing process of Heal-X; ii) validate the functionality of Heal-X post-manufacture; iii) optimise dose in a clinically relevant model compared to best-in-class; and iv) file IP, understand techno-economics and develop a business plan to ensure Heal-X becomes a revenue-generating product. The decision to develop Heal-X using XapHe's platform technology is business-driven, in that it represents the shortest route to revenue generation. This funding will accelerate our business, provide necessary data, and enable us to partner with investors, the pharma industry and healthcare providers, thereby supporting the only RNA company in NI.