“Ceramic skin patches for a silent pandemic”
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Mike G.W. de Leeuw - CEO
MyLife Technologies BV
Leiden, The Netherlands
A Silent Pandemic(s):
Predictable - Preventable – Manageable - Curable
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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
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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
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Deliver inside the skin…
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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
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• 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
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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
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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
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Mike G.W. de Leeuw
CEO
mike@mylifetechnologies.nl
www.mylifetechnologies.nl