Posters – Infectious diseases and Vaccines NAME OF THE PROJECT NAME OF THE MAIN CONTACT ORGANISATION NAME Smart microneedle patches for dermal delivery Pieter Jan Vos MyLife Technologies BV MyLife Technologies are developing a platform technology based on nanoporous MicroNeedle Arrays (npMNA’s), which are integrated into a patch for drug delivery through the skin. Technology The 2 main distinguishing features of our technology are widely recognized by the industry : we offer ceramic and nanoporous microneedles arrays. The nanopores alloc for dtorage of active compounds, such as vaccines, inside the device consisting of microneedles connected to a blackplate. Once brought into proper contact with the skin, the vaccine diffuses from the nanopores into the outer skin layers targeting the dendritic cells. The microneedles pierce the stratum coreum and reach into the epidemia / dermis. Customers / Target market We are focusing on the following drug delivery market segments : prophylactic vaccines (infectious diseases), therapeutic vaccines (immunotherapy) as well as specific small molecules. Intradermal deliver of vaccines substantially enhances the efficacy of vaccines and implies a dose sparing potential of a factor 5 to 100 compared to intramuscular injection of vaccines. Our collaboration partners include big pharma, small biotech and academia. Together with our partners we are running co-development projects or jointed grant applications. The markets of prophylactic and therapeutic vaccines show high growth rates. Industry and competitors The large majority of the microneedle technology developers focus on either solid microneedles or hollow microneedles. Solid microneedles can be used in various ways: poke & patch (microneedles perforate the skin and consequently a drug containing patch is applied onto the skin), coat & poke (drug coated microneedles are applied on the skin for release of the coating), poke & dissolve (drug containing polymer microneedles dissolve in the skin) MyLife Technologies holds unique position by offering a poke & diffuse technology: Drugs entrapped in the nanopores of the microneedles arrays diffuse into the skin after administration. Competitors include among others 3M, Corium and Vaxxas. Financing need / Commercial opportunity IP – Patent situation We are currently looking for 1 million € funding. The funding will be used for the following purposes: accelerate & intensifu development program (preclinical proof-of-concept studies are ongoing for various applications) expand our lab facilities at BioScience Park, Leiden, The Netherlands Scale-up and automation of the microneedles array production Our technology is patented under the following patent reference : Invention “WO 1008113856 (A1) – Integrated microneedle array and a method for manufacturing thereof”. Based on this application, patents have been granted in United States (8903384), Japan (5517956), China (200980117052.4) and Europe (2262722). Three more patent applications are still pending at present. Milestones achieved: Feasibility studies for drug delivery of various compounds in ex-vivo skin models have been completed. Future steps / Milestones We are currently conducting Proof-of-Concept studies in relevant animal models in various therapeutic areas : prophylactic vaccines, therapeutic vaccines (peptide) and small molecules. Most of the Proof-of-Concept studies are done in collaboration with partners. First POC studies should be completed by Q1 2016. 1. 2. Further reading 3. 4. Contact person K. Van der Maaden et al., Microneedle-based drug and vaccinces delivery via nanoporous microneedle arrays, Drug Deliv Trans Res (2015), doi :10.1007/s13346-015-0238-y Z. Ding et al.; Microneedle arrays for the transcutaneous immunization of diphtheria and influenza in BALB/c mice, J Control Release (2009), doi:10.1016/j.jconrel.2099.01.025 A. Boks et al.; Cotrolled release of a model vaccines by nanoporous ceramic microneedle arrays, Internation Journal of Pharmaceutics (2015), doi: 10.1016/j.ijpharm.2015.06.025 M. Verhoeven et al., Applying ceramic nanoporous microneedle arrays as a transport interface in egg plants and an ex-vivo human skin model, M., Microelectronic Engineering (2012), doi:10.1016/j.mee.2012.07.022 Mr. P J (Pieter Jan) Vos, CEO, MyLife Technologies BV, pjvos@mylifetechnologies.nl 1/2