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www.enesipharma.com
Summary Presentation
October 2019
Non-Confidential
• 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 such products have potential to transform the performance
and delivery of vaccines, facilitating increased uptake, coverage and make a
material impact on global health and healthcare economics.
• Significant potential benefits for all population groups, health-care professionals,
and payers across the global vaccine ecosystem.
• Proven Management Team and International Scientific Advisory Board.
• Based Oxfordshire, UK.
Enesi Overview‘Vaccination Saves Lives’
Enesi are building a UK-based world leading company of exceptional potential value
and will make a material positive impact on global health
2
ImplaVax® Solid Dose Vaccine TechnologyMaking a Material Impact on Global Health
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 Vaccine3
ImplaVax® Solid Dose Vaccine TechnologyCombination of unique formulation and device technology
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 and wastage
• Saves time
Robust IP position and significant know-how with protection through 2039
2
Multi-Use Actuator
• Spring loaded
• Activated by downward pressure on skin
• Audible click confirms delivery
• Re-useable up to 1,000 times, if required
3
1
Universal Vaccine Implant (UVI)
• Unit solid dose
• Enhances immune response and immunogenicity
• Dosing and regimen sparing demonstrated
• Made using proprietary formulation technology
• Eliminates need for point-of care reconstitution with diluent
• Eliminates needle-stick-injury and sharps disposal challenge
• Unit dose delivery assured each time, and every time
• Enhanced thermal stability with reduced / negated cold chain
1
4
1
5
Enesi Business Strategy3 reinforcing complimentary activities driving serial value
Licensing
Select partnerships,and co-developments1
e.g. Bigger Pharma, Specialty Players, Niche Opportunities,
Government LaboratoriesUniversities
Global Public Interest Projects
Grants & Philanthropic Funds
e.g. BARDA, CEPI, CARB-X,PATH, BMGF, Innovate UK
WHO, Gavi
1 Licensing• Near term Revenues
• Target and Term 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 non-dilutive Government and
philanthropic capital and NGOs
• Commercial rights retained in developed
world markets
Supported by Key Clients, Collaborators and 3rd Party Manufacturing Partners
Future ProductSales
Targeting Unmet Need
e.g. AMR, Allergy,Emergent Threats,Priority Pathogens
Enesi Pipeline and ReachRobust IP protection through 2039
Traditional
Products
DNA/RNA
Lower
Higher
Re
lati
ve
va
lue
ad
d
Relative Complexity
Allergy
‘Disease X’
Lower Higher
Cancer
Emerging
Pathogens Biodefence
Breadth of Enesi client pipeline1
6
7
Selected ImplaVax® PartnershipsNon-exhaustive list of collaborators; many more not disclosed
8
Comparison to Other PlatformsImplaVax® enabled products can be market leading
Va
ccin
e D
eli
ve
ry S
yst
em
Sta
tus
Ne
ed
le F
ree
Dil
ue
nt
Fre
e
Co
ld C
ha
in N
ee
d
Un
it D
ose
Ass
ure
d
Ad
juv
an
t F
ree
Cro
ss C
on
tam
ina
tio
n R
isk
Wa
sta
ge
Ra
te
Do
se /
Re
gim
en
Sp
ari
ng
Sh
ow
n
Ad
min
istr
ati
on
Ch
all
en
ge
To
tal
Tim
e t
o A
dm
inis
ter
Inje
ct S
ite
Iss
ue
s
To
tal
Co
st p
er
De
liv
ere
d
Do
se
Needle & Syringe Commercial No Sometimes High Yes Sometimes High High No Med-High 30 sec Frequent Low-Med
Microneedle Add on Development No Sometimes High Yes Sometimes High High Yes Med-High 45 sec Frequent Low-Med
Hydrodynamic Injectors Semi-Commercial Yes Sometimes High Yes Sometimes Low Medium Possibly Med-High 60 sec Frequent Med
Microneedle Patch Development No Yes Med No Unknown High Low Possibly Med-HighUp to 30
minsFrequent Med
Laser Poration Semi-Commercial Yes Sometimes High Unknown Unknown Low Medium Possibly High Minutes Unknown High
ImplaVax® Development Yes Yes Low Yes Yes Zero Zero Yes Low< 20
SecsNone
Potentially
Least
• ImplaVax® has potential to be the world’s leading and default vaccine platform
• All vaccines delivered subcutaneously
• Solid implant (#2) better than standard vaccine delivered by needle and syringe (#1) achieving
comparable performance after only 1 boost
• Reconstituted solid dose formulation control (#3) is comparable to standard vaccine
• Suggests solid dose implant may have its own beneficial effect
(#1)
(#2)
(#3)
Solid Implants Improve Immune Response #1Diphtheria - Guinea Pig Immunogenicity Study
9
10
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
11
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 (FXX-10-SC Blue Lines) tested at various antigen1 loadings; SC2 delivery,
no adjuvant. 2 Dose Regimen with dosing at Day 0 and Day 28
• Significantly higher antibody levels observed for all Enesi formulations (#1), compared to
commercially available standard delivered intramuscularly (IM) used as active control
• Suggests antibody levels with a single dose of Enesi formulations are sufficient to
rapidly achieve target response level at day 12 (#2), evidencing regimen sparing and
potentially transforming protocol
Solid Implants Improve Immune Response #4Rabbit Immunogenicity Studies
1 rPA targeting specific Biothreat2 Subcutaneous
(#2)
(#1)
12
• 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
13
Solid Implants Enhance StabilityPotency and mechanical performance maintained
Re
cove
ry
14
• No significant effects or SAE’s were observed during the trial
• No oedema, bleeding, ‘blebbing’, or serum leakage using the solid dose
• After the trial, only 10% of patients mentioned the red mark at all
Pre Dose Post Dose
1hr Post Dose 12hr Post Dose
Administration Site ObservationsStudy utilising therapeutic peptide delivered in solid dose form
Final Product Assembly OverviewManufacturing Process
• Lyophilization /
Spray drying
• Extrusion /Micro tableting
• Drying
• Cutting
Assembly
Cassette
IPC
Pouching
LabellingIPC
Foil Pouch
Release Testing
4m
m
0.85 mm
Unit Solid Dose
Implant
Implant Manufacture
+
FinalProduct
IPC
NB: Not to scale
Parenteral Excipients
Bulk Vaccine(Liquid or Powder)
15
Device ManufacturingLeveraging leading medical device manufacturing partner
• Long term relationship
• World scale capable
• All IP and design rights owned by Enesi
• Working to relevant industrial standards and guidance from appropriate
international regulatory bodies
• Independent industry leading analysis confirms ImplaVax® competitiveness
16
17
Human Factor StudiesResults from recent Formative Study
Would you prefer an injection with ImplaVax® or needle and syringe (N&S)?
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
HCP was retiring 1 week post study
HCP would prefer ImplaVax® to N&S if ImplaVax® device was approved
HCP provided suggestions for improvement which have now been implemented
• How do you feel about this
device being used to give
your child a vaccination?
Positively
Negatively
Parents of Infants
< 18 months
Parents of Children
2 -12 years
• Would you prefer your
child to have an injection
with ImplaVax or needle
and syringe?
ImplaVax
Needle
• How acceptable would
you find it to have your
child vaccinated with
this device?
Very acceptable
Very unacceptable
Acceptable
Unacceptable
Neither
Human Factor StudiesStrong Subject Preference Evident January 2018
18
19
Strong Subject Preference EvidentHuman Factor Study Feedback
“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”Nurses
“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”
Aid Workers
Parents of
Infants & Children
“Less daunting than a needle”“Whole lot cleaner” “No risk of infection” “Really good!”“My 3 year old daughter has sensory issues; She probably won't even realise she is having an injection.”
Adults
“Less threatening, less trepidation, less scary”“Really quick and easy and I didn't feel a thing”“I would probably seek this out, when booking, if there was an option”
20
ImplaVax® Summary
Better Products
Target AgnosticEnhanced Immunogenicity
Prophylactic and Therapeutic
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 subject and HCP preference
High Value Adding
Dose and Regimen SparingCost Effective
ImplaVax®
www.enesipharma.com