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CERAMIC SKIN PATCHES FOR A SILENT PANDEMIC

iQHub
27. Mar 2023
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CERAMIC SKIN PATCHES FOR A SILENT PANDEMIC

  1. “Ceramic skin patches for a silent pandemic” 27-3-2023 MyLife Technologies BV - Copyright 1 Mike G.W. de Leeuw - CEO MyLife Technologies BV Leiden, The Netherlands
  2. A Silent Pandemic(s): Predictable - Preventable – Manageable - Curable 27-3-2023 MyLife Technologies BV - Confidential 2 Human Papilloma Virus (HPV) and cancer: • 4% of all new cancer cases annually – 700,000 cases diagnosed & reported in 2018 (CAGR= 5%). • 560.000 deaths attributed to HPV in 2018 of which 70% in LMICs (Low & Middle Income Countries). • Variants HPV-16 and HPV-18 are most common • 13 different oncogenic HPV-variants can induce 8 different tumor diseases. • Transmission via sexual activity = 80-90% of all adults had an HPV-infection at least once – 10% with one of the oncogenic variants…
  3. HPV-vaccination – The Problem 27-3-2023 MyLife Technologies BV - Confidential 3 Human Papilloma Virus (HPV) and preventive vaccination: Vaccinate prior first sexual activity – for life long protection Age 9-11 1 vaccination Age 12-15 2 vaccinations within 1 year Herd protection: needs vaccination uptake at 70% for both genders HICs 40-60% girls (…but low in most migrant populations and boys) LMICs ±10% Second dose vaccine uptake < 80% of primary vaccination 1. Shortage of supply for LMIC’s 2. National and ‘Last-Mile’ cold chain distribution (costs) 3. Needle Anxiety – 30% of all adults 4. Post Covid ‘Vaccination Fatigue’
  4. Ceramic Skin Patches for Global Vaccination 1. 5-20x less vaccine actives required, with no/less Adjuvants 2. Ambient stable – No Cold Chain Distribution 3. Simple Skin Patch applied in 30 seconds… Pain-free 27-3-2023 MyLife Technologies BV - Copyright 4
  5. Ceramic Skin Patches in close-up… 27-3-2023 MyLife Technologies BV - Copyright 5 475 µm Nano Pore Size = ±80nm 275 µm Tip diameter < 2 µm Ø = 9 mm 105 needles
  6. Deliver inside the skin… 27-3-2023 MyLife Technologies BV - Copyright 6 Minimally invasive & pain- free Micro Needle Array H y p o d e r m i c n e e d l e Invasive & pain-full High density immune cells No immune cells…
  7. Ceramic Skin Patches – Unique Selling Proposals 3rd Generation Micro-needle Array Patches: 1) Highest loading capacity of all MAP’s interconnected nano-pores = 10’s µg’s up to mg’s 2) Inert material – maximum formulation freedom Sintered at 1450℃ = no leachables, no degradation products 3) Customizable and scalable Existing manufacturing technology, decentralized and mobile Pre-clinical delivery of mRNA nano particles established Clinical trial COVID-19 mRNA safety study successfully completed Preparing Pilot Plant scale-up to millions of units per year Patents granted in US-EU-CHN-JPN Tested with VLP’s, plasmid DNA, mRNA, MAb’s, peptides, toxoids, synthetic small molecules 27-3-2023 MyLife Technologies BV - Copyright 7
  8. 27-3-2023 MyLife Technologies BV - Confidential 8 • Excellent adhesion • Fast loading and drying at ambient or cooled temperatures • Completely inert: no leachables & no degradation products. • Interconnected nano-pores, expandable volume. • Tuneable delivery: - high or low loading - fast or slow release - smaller or larger pores Surface topography & nano pores make the difference…
  9. HA + alum PBS HA PBS HA 100 % survival 100 % mortality within 8 days Schepens, B., Vaccination with influenza hemagglutinin-loaded ceramic nano-porous microneedle arrays induces protective immune responses, European Journal of Pharmaceutics and Biopharmaceutics 2019, Volume 136, Pages 259-266 [open access] 9 27-3-2023 MyLife Technologies BV - Copyright npMNA Influenza-A Challenge Study: H1N1-subunit vaccine (spike protein) Influenza mouse model study shows high immunization and complete protection against a lethal viral challenge… with a 6x lower dose delivered via ceramic skin patch compared to intra muscular jab
  10. Current projects at MyLife Technologies 1. HPV skin patch vaccination for children and adolescents 2. HPV-induced cancer vaccines 3. mRNA & DNA delivery projects for Pharma-innovators 4. Scale-up to pilot plant 27-3-2023 MyLife Technologies BV - Copyright 10 1) siRNA conjugated with near infra-red dye; 2) packaged in ambient stable nano-particles; 3) Tip-loaded onto our ceramic Micro needle Array Patches (MAPs); 4) delivered successfully in vivo in mice (December 2022)
  11. Call to Action – Partnering We develop improved vaccine delivery options: • For novel vaccines • For registered vaccines We collaborate with Vaccine innovators, NGO’s and government: 1. Feasibility studies 2. Product development projects into Clinical trial 3. Technology Licensing 4. Sourcing of Ceramic MAPs Preparing for a new investment round of €15 million 27-3-2023 MyLife Technologies BV - Copyright 11
  12. 27-3-2023 MyLife Technologies BV - Copyright 12 Mike G.W. de Leeuw CEO mike@mylifetechnologies.nl www.mylifetechnologies.nl
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