Enesi Pharma Summary Presentation November 2018€¦ · Summary Presentation November 2018 •...

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www.enesipharma.com Enesi Pharma Summary Presentation November 2018

Transcript of Enesi Pharma Summary Presentation November 2018€¦ · Summary Presentation November 2018 •...

Page 1: Enesi Pharma Summary Presentation November 2018€¦ · Summary Presentation November 2018 • Enesi Pharma is an innovative pharmaceutical company developing a range of novel injectable

www.enesipharma.com

Enesi Pharma

Summary Presentation

November 2018

Page 2: Enesi Pharma Summary Presentation November 2018€¦ · Summary Presentation November 2018 • Enesi Pharma is an innovative pharmaceutical company developing a range of novel injectable

• 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

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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

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• 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

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• 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