The Photochemical internalization (PCI) PCI technology can be used for enhancing the intracellular delivery of many different types of molecules with therapeutic activity or therapeutic potential. Clinical studies are on-going with the use of PCI for improving the effect of a cancer chemotherapeutic agent, as well as for evaluation of the potential of PCI for enhancing the effect of vaccination with peptide and protein antigens. The application of PCI in these areas will be discussed.
In addition to the applications already in clinical development the PCI technology also has a large potential for the use in other therapeutic areas. Thus, in preclinical studies very interesting results have been achieved using PCI for the delivery of various types of nucleic acids, with especially interesting results for mRNA delivery. mRNA are molecules with a very interesting therapeutic potential if the current delivery problems could be solved, and pre-clinical results indicate that PCI may contribute to solving these problems for several potential uses of mRNA-based therapeutics.
PCI has also shown very promising results with protein-based cytotoxic agents such as protein toxins and immunotoxins, as well as for drug delivery mediated by various types of nanoparticles. Recently, it has also been shown that PCI can enhance the intracellular delivery of certain antibiotic agents, with a potential to treat local infections with intracellular pathogens.
Key pre-clinical findings in these areas will be presented, and current and potential clinical uses of the PCI technology will be discussed.
In the fimaVacc technology photochemical internalization (PCI) is employed for enhancing cytotoxic T-cell responses to vaccination. Thus, in pre-clinical studies fimaVacc has been shown to increase MHC class I antigen presentation, leading to strongly enhanced cytotoxic- and helper T-cell responses to various types of vaccines. On the basis of promising preclinical results, a phase I clinical study with fimaVacc has been performed in healthy volunteers. FimaVacc involves formulating the vaccine with a photosensitising compound (fimaporfin) and a toll-like receptor (TLR) agonist. The vaccine is given as intradermal injections followed by illumination of the vaccination site. Results from a phase I clinical study in healthy volunteers will be presented. The subjects were vaccinated with models for peptide- and protein-based vaccines; HPV16 E7 peptide antigens and Keyhole Limpet Hemocyanin. Both antigens were formulated with the TLR3 agonist poly-ICLC (Hiltonol), and up to three vaccinations were be given. Local and systemic adverse effects will be assessed, and cellular and humoral immune responses were analysed by ELISPOT and ELISA assays, and by flow cytometry.
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