enesi pharma summary presentation november 2018€¦ · summary presentation november 2018 •...
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www.enesipharma.com
Enesi Pharma
Summary Presentation
November 2018
• Enesi Pharma is an innovative pharmaceutical company developing a range
of novel injectable solid dose vaccine products, enabled by our proprietary
ImplaVax® formulation and device technologies.
• Data suggests that these products have the potential to transform the
performance and delivery of vaccines, facilitating increased uptake, coverage
and make a material impact on global health.
• Significant potential benefits for patients, health-care professionals & payers.
• Experienced Management Team and International Scientific Advisory Board.
• Privately Held, Based Oxfordshire, UK.
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Enesi Overview’Vaccines don’t save lives, Vaccination does’
Enesi represents a unique opportunity to build a world leading company
of exceptional value and make a material impact on global healthcare
ImplaVax® Solid Dose Vaccine TechnologyCombination of unique formulation and device technology
Distribute
With Ease
Administer
To All
Thermally
Stable
Easy & Rapid
Administration
Enhanced
Immune Response
Highly
Cost Effective
Strong Subject
Preference
Design
For Purpose
Produce
On Demand
Needle Free
By Design
Reduced
Cold Chain
Eliminates
‘Mix & Shoot’Error Free
Unit Dosing
Stockpile
Optimisation
3
2
1
3 Reusable Actuator (1,000x)2 Single Use Disposable Cassette1 Unit Solid Dose Vaccine Implant
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ImplaVax® PlatformCombination of unique formulation and device technology
1. Universal Vaccine Implant (UVI)
• Unit solid dose
• Enhances immune response and immunogenicity
• Dosing and regimen sparing demonstrated
• Made using proprietary formulation technology
• Adjuvant free
• Eliminates need for point-of care reconstitution with diluent
• Eliminates needle-stick-injury and sharps disposal challenge
• Unit dose delivery assured – each time, every time
• Enhanced thermal stability with reduced / negated cold chain
3. Multi-Use Actuator
• Spring loaded
• Activated by downward pressure on skin
• Audible click confirms delivery
• Re-useable up to 1,000 times, if required
2. Single-Use, Unit Dose Cassette
• Contains solid vaccine implant (UVI)
• Needle free by design
• Viewing window confirms delivery
• Lock-out mechanism prevents re-use
• Eliminates cross-contamination
• Reduces error
• Reduces wastage
• Saves time
Robust IP position and significant know-how with protection through 2036
2 m
m4
mm
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Vaccine EvolutionEnabled by ImplaVax® as potential platform of choice
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Solid Implants Improve Immune Response #1Diphtheria - Guinea Pig Immunogenicity Study
• Enesi implant better than standard vaccine delivered by needle and syringe
• Reconstituted solid dose formulation control is comparable to standard vaccine
• Suggests solid dose implant may have its own beneficial effect
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Solid Implants Improve Immune Response #2(i) Haemophilus Influenzae Type B (Hib) - Immunogenicity Studies
(ii) Follow Up Pooled Serum Rat Challenge
• Enesi implant better than standard vaccine delivered by needle and syringe
• Immune response from 1st boost dose better than standard post 2nd boost
• 100% protection rate achieved in follow on rat challenge study
(i) HIB - Guinea Pig (ii) HIB – Rat Challenge
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Solid Implants Improve Immune Response #3Influenza H3N2 Immunogenicity Studies1 – Ferret Model
• Seroprotection achieved with single dose delivered by SC2 solid implant
• Viral shedding significantly reduced with SC solid implant as compared to either
IM deliveries and control group
• Peak viral shedding delayed by 1 day
Control Implant
IM
Implant Recon
IM
Implant
SC
Me
an
Ma
xim
um
Vir
us
Tit
re
1 Primed intranasally Day -49 with Influenza A/New Caledonia/20/99 (H1N1), immunised with test vaccines or control at Day -28 and Day -7,challenge at Day 0 with Influenza A/Wisconsin/67/2005 (H3N2)
2 Subcutaneous
• Enesi formulations tested at various antigen1 loadings; SC2 delivery, no adjuvant
• Significantly higher antibody levels observed for Enesi formulations, compared to
placebo and commercially available standard used as active control
• Suggests antibody levels with a single dose of Enesi formulations are sufficient to
rapidly achieve target response level, transforming dosing regimen and protocol
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Solid Implants Improve Immune Response #4Rabbit Immunogenicity Studies
1 rPA targeting specific Biothreat2 Subcutaneous
• Antigen formulated into solid dose implants
• 3 different test methods confirm retained potential potency of antigen
• Exemplar stability with potency retained after 15 months storage at 40˚C,75% RH
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Solid Implants Enhance StabilityPotency and mechanical performance maintained
Re
cove
ry
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Latest Human Factor StudyResults from Formative Study, January 2018
ImplaVax® Don’t mind
N&S
High Income Country Nurses
Parents of Infants < 18m
Parents of Children 2 -12 yr
Recently Vaccinated Adults
Aid Workers
Would you prefer an injection with ImplaVax® or needle and syringe (N&S)?
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Strong Patient Preference #1Human Factor Study – January 2018
Aid Workers
“The storage conditions - I love it”
“Ideal for developing countries”
“It's easy - less exposure to needle”
“Doesn't need specialist training - we have a lot of trainee and junior doctors”
Nurses:
“When the child sees a needle that's when they freak out …… This doesn't even look like you're giving a vaccination”
“It would save a lot of trouble for us regarding refrigeration”
“ Standardises everything”
“ After half an hour of using it, you'd be using it in seconds”
“It's all in one; no mixing, no drawing up ... Just quick clean and easy”
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Strong Patient Preference #2Human Factor Study – January 2018
Adult Volunteers
“Less threatening, less trepidation, less scary”
“Really quick and I didn't feel a thing”
“Really quick and easy
“I would probably seek this out, when booking, if there was an option”
Parents of Infants and Children
“Less daunting than a needle”
“Whole lot cleaner”
“No risk of infection”
“My 3 year old daughter has sensory issues and is sensitive to touch ….... She probably won't even realise she is having an injection.”
“Really good!”
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Enesi Business Strategy3 reinforcing activities driving value
Licensing
Select partnerships,and co-developments
e.g. Bigger Pharma, Specialty Players, Niche Opportunities,
Government Laboratories
Future ProductSales
Targeting Unmet Need
e.g. AMR, Emergent Threat Pathogens
Global Public Interest Projects
Grants & Philanthropic Funds
e.g. BARDA, CEPI, CARB-X,PATH, Gates Foundation
1 Licensing• Near term Fee-for-Service revenues
• Target specific collaborations
• Staged Access Fee & Milestones
• Product Sales & Royalties
3 Future Product Sales• Own-funded new product development
targeting areas of unmet need
• Commercial rights retained in full
2 Global Public Interest Projects• Co-funded targeted product development
leveraging philanthropic and non-dilutive
capital and NGOs
• Commercial rights retained in developed
world markets
Supported by Key Clients, Collaborators and 3rd Party Manufacturing Partners
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ImplaVax® Summary
Better Products
Enhanced ImmunogenicityProphylactic and Therapeutic
Adjuvant Free
Enhanced Stability
Reduces Cold Chain ChallengeExtends Shelf Life
Reduces stockpiling
Ultimate Convenience
Quick, Easy, Intuitive to UseNeedle free by design
No diluent or ‘mix and shoot’Clear patient and HCP preference
Value Adding
Dose and Regimen SparingPotential least cost per
delivered unit dose
ImplaVax® Platform
Enesi represents a unique opportunity to build a world leading company
of exceptional value and make a material impact on global healthcare