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“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
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…
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’
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
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
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…
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
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…
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
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)
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
27-3-2023 MyLife Technologies BV - Copyright 12
Mike G.W. de Leeuw
CEO
mike@mylifetechnologies.nl
www.mylifetechnologies.nl

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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