The Future of Allergy Treatment: Ultra-Fast Desensitization (SIT) Swiss Biotech Day

The Future of Allergy Treatment:
Ultra-Fast Desensitization (SIT)
Swiss Biotech Day
9 April 2013
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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a new player in the field of Allergy
 Clinical-stage biopharmaceutical company based at the Epalinges
Biopôle (Lausanne) founded by Prof F Spertini, MD
 Proprietary technology for allergy vaccines based on long peptides,
initially developed at UNIL/EPFL and CHUV
 Internal R&D laboratory for allergy vaccines and immunology,
collaborating with local research centers
 Raised CHF 22 million to date from biotech funds and other investors
(+ private investors)
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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Experienced Management Team
Vincent Charlon PhD
CEO
Christophe Reymond PhD
CSO
Gilles Della Corte MD
Clinical Development
François Spertini MD
Allergy Expert, Founder
Eva Castagnetti PhD
Product Development
Jean-Paul Rohmer PhD
Business Development
Zoltan Czigler MBA
Finance & Admin
Gerard Farmer PhD
Regulatory
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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Allergy is a Global Public Health Issue
 Considerable Medical Need and Market Opportunity
> 500 million patients
A global pharmaceutical market over € 10 billion/year
Fastest growing chronic condition affecting up to 30-40% of the population
Specific Immunotherapy (SIT) is the only long-term cure for allergies
SIT sales: € 1 billion (+8%/year)
SIT use limited by
- treatment duration - 3 years
- poor compliance - 50% dropouts at 1 year
- use of crude extracts - poor product quality
SIT: specific immunotherapy
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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Allergy SIT: A Rapidly Changing Market
 Allergen SIT companies become pharmaceutical companies
 Pharmaceutical companies become interested by allergen SIT
SIT efficacy now proven in
multiple clinical trials
New SIT European
regulations issued in 2009
ALK Abello invests in DBV (2009)
ALK buys Nelco and Fornix (2010)
Stallergenes is acquired by Ares
Life Sciences (2011)
Ares LS to acquire US Greer Labs
(2013)
Torii acquires Japanese rights
from ALK with 30 M€ upfront
(2011)
Shionogi acquires Japanese
rights from Stallergenes with
24 M€ upfront (2011)
Early stage DBV Technologies
IPO valued 120 M€ (2012)
Merck AG integrates
Allergopharma in Merck-Serono
Allergy Business Unit (2012)
Ongoing US FDA reviews of
several SIT NDAs
Merck Inc develops allergen
immunotherapy products in US,
Grazax NDA filed (2013)
Sanofi enters allergen
immunotherapy through R&D
collaboration with Selecta
Biosciences (2012)
SIT: specific immunotherapy
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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SIT with Contiguous Overlapping Peptides
“COP Allergy Vaccines”
Allergen
COP-1
ANERGIS IP
COP-2
COP-3
--------------------------
 Long synthetic peptides (40-80 aa)
 Complete allergen sequence with terminal overlaps
 No detectable binding to IgEs from allergic patients
 SIT with COPs in lieu of conventional extracts or allergens
SIT: specific immunotherapy ; COP: Contiguous Overlapping Peptides ; aa: amino acid
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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Advantages of COP Allergy Vaccines
No conformational
epitopes (no IgE binding)
All T-cell epitopes
(full allergen sequence)
Pathway of long peptides
similar to allergens
Safe at high dose
Synthetic GMP peptides
Two-level patent
protection
High Safety
Strong Immunogenicity
SIT Efficacy
Much Shorter Treatment
Pharmaceutical Quality Products
Strong IP Position
SIT: specific immunotherapy ; IgE: Immunoglobulin type E ; GMP: Good Manufacturing Practices ; IP: Intellectual Property
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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Reducing SIT treatment to 2 Months
COP Allergy Vaccines
Treatment
1st year
2nd year
3rd year
Anergis
5 injections
SCIT
50 injections
SLIT
Up to 1000 doses
SIT: specific immunotherapy ; SCIT: subcutaneous SIT ; SLIT: sublingual SIT
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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Significant Market Opportunities
COP Allergy Vaccines
Target Population:
15-20 % moderate to severe patients who consult an allergy specialist
Indication
birch
Patients
32 000 000
Treated
1-2 %
Potential
800 M €
AllerDM dust mites
110 000 000
1-2 %
2 billion €
27 000 000
0.5-1 %
AllerT
AllerR
ragweed
300 M €
AllerT: candidate allergy vaccine against birch pollen allergies, AllerDM against dust mites allergies , AllerR against ragweed allergies
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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COP Discovery Engine  Product Pipeline
COP Selection
No IgE binding
Immunogenicity
Pre-IND
Clinical
Phase I/IIa
AllerT (birch)
Clinical
Phase III
2014
AllerR (ragweed)
2014
AllerDM (dust mites)
2014
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
Clinical
Phase IIb
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Clinical Proof-of-Concept
AllerT Phase I/IIa in Patients Allergic to Birch Pollen
 Double-blind, randomized, placebo-controlled
 AllerT (N=15) or placebo (N=5) – subcutaneous injections on days 1, 7, 14, 21 and 51
 Cumulative dose of 440 µg equivalent to ~3 years of conventional SCIT
 Safety proof of concept
 No immediate allergic reactions
 Well tolerated
 Immediate efficacy trend during the first post-treatment season
 Quality of life and symptom scores improve by 31-35% with AllerT
 Immunology proof of concept
 Strong increases in IL-10 and allergen-specific IgG4 in all patients
 Persistent increase in IgG4 after 2 and 4 seasons
SIT: specific immunotherapy ; SCIT: subcutaneous SIT ; IL-10: interleukin-10 ; IgG4: Immunoglobulin type G4
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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Long Term Immune Memory: Vaccine Effect
Allergen-Specific IgG4 after 2nd and 4th Seasons
p < 0.001
p < 0.001
Baseline = 100
600
400
Placebo
AllerT
200
0
Baseline
Fall 2008 before treatment
2010
2 months after 2nd season
2012
2 months after 4th season
Data (median) from blood samples collected in July 2012 from subjects allergic to birch pollen who had received 5 SC injections over 2 months of placebo or AllerT in trial AN003.
All within group changes from baseline for placebo are NS. Placebo N=5, AllerT N=15.
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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AllerT Ongoing Phase IIb Trial
 Placebo-controlled, double-blind, randomized multicenter trial
 25 European trial centers, up to 300 patients
 Switzerland, France, Poland, Latvia, Lithuania, Sweden and Denmark
Subject screening
Pre-seasonal treatment
5 injections / 2 months
Oct 2012 – Jan 2013
Nov 2012 – Mar 2013
birch pollen season
Mar-Jun 2013
AllerT 50-100 µg
moderate to severe
allergy to birch pollen
AllerT 25-50 µg
Results
Q3
2013
Placebo
Safety & Tolerability
Symptom & Medication Scores
Quality of Life
Immunology Markers
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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Anergis Milestones
Founded by
F Spertini
UNIL patent
acquisitions
2002
CTI grant
for AllerT
2005
Bee
venom COP
Round A
CHF 18 M
2008
Birch
pollen COP
Bee
venom
Phase I/IIa
Round B
+/- Partner
2011
Ragweed
pollen COP
Birch
Pollen
Phase I/IIa
2014
House dust
mites COP
Birch
Pollen
Phase IIb
Birch
Phase III
Ragweed
Phase I
Dust mites
Phase I
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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The Future of Allergy Treatment:
COP Allergy Vaccines
Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013
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