The Future of Allergy Treatment: Ultra-Fast Desensitization

The Future of Allergy Treatment:
Ultra-Fast Desensitization
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
[email protected]
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is a Swiss clinical-stage biopharmaceutical company with :
 a pipeline of innovative proprietary allergy vaccines in development
 an immunology and peptide research laboratory
 a management team with strong Pharma and Biotech background
Anergis raised CHF 30 M to date from biotech funds and other investors
(+ private investors)
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
[email protected]
2
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 25-30% of the population
Allergy Immunotherapy (AIT) is the only long term cure for allergies
AIT sales: 1 billion € (+ 8% / year)
AIT use has been limited by
treatment duration :
poor compliance :
use of crude extracts :
Not for distribution without approval from Anergis | July 2014
3-5 years
50% dropouts at 1 year
poor product quality
www.anergis.ch
[email protected]
3
Ultra-Fast Desensitization in 2 Months
Proprietary COP Allergy Vaccines
Treatment
1st year
2nd year
3rd year
Anergis
5 injections
Subcutaneous AIT
50 injections
Sublingual AIT
Up to 1000 doses
AIT: Allergy Immunotherapy
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
[email protected]
4
The Future of Allergy Treatment
short-term
non-specific
symptom relief drugs
2014
2020
short-term
non-specific
symptom relief drugs
Ultra-fast AIT
2-4 billion €/year
3-year
AIT
3-year
AIT
Long term efficacy similar to 3-year AIT
Markedly improved convenience and compliance
Pharmacoeconomic benefit
Source: Business Insights May 2011 Allergic Rhinitis, Anergis external market research and Anergis sales forecasts
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
[email protected]
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AIT with Contiguous Overlapping Peptides
“COP Allergy Vaccines”
Allergen
COP-1
ANERGIS IP
COP-2
COP-3
--------------------------
 Long synthetic peptides (40-80 aa)
 Containing the complete allergen sequence with terminal overlaps
 No detectable binding to IgEs from allergic patients
 AIT with COPs in lieu of conventional extracts or allergens
AIT: Allergy immunotherapy ; COP: Contiguous Overlapping Peptides ; aa: amino acid ; IP: intellectual property ; IgE : Immunoglobulin G type E
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
[email protected]
6
Advantages of COP Allergy Vaccines
No conformational
epitopes (no IgE binding)
Safe at high dose
Safety, allowing increased dosing
Much Shorter Treatment
Full allergen sequence
Optimal B and T cell responses
COP presentation
similar to allergens
Efficacy comparable to conventional AIT
Synthetic GMP peptides
Two-level patent
protection
Pharmaceutical Quality Products
Strong IP Position
AIT: allergy immunotherapy ; IgE: Immunoglobulin type E ; GMP: Good Manufacturing Practices ; IP: Intellectual Property
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
[email protected]
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COP Allergy Vaccine Pipeline
Preclinical
Pre-IND
AllerT
Phase I
AN002T AN003T
Phase II
Phase III
AN004T AN005T …
Birch pollen
AllerDM
House dust mites
AllerR
Ragweed pollen
Next
Generation
COP selection
In vitro tests
Mice studies
Not for distribution without approval from Anergis | July 2014
Manufacturing
Toxicology
www.anergis.ch
Skin tests
Phase I/IIa
[email protected]
Phase IIb
200-300 pts
Phase III
800-1200 pts
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Clinical Proof-of-Concept Trial
AllerT (birch)
 Pre-Phase I/IIa: absence of detectable IgE binding
 in vitro with sera from allergic patients and in a sensitized mice model
 No reactions to skin prick tests in allergic patients (clinical trial AN002T)
 Clinical Phase I/IIa in allergic patients (AN003T)
 Double-blind, randomized AllerT (15) vs placebo (5)
 Subcutaneous injections on days 1, 7, 14, 21 and 51
 Cumulative dose ~3 years of conventional SCIT
Results:




Safe and well tolerated
Seasonal clinical improvement trend
Strong immunological effects
Long term vaccine effect (next slide)
Anergis results from AllerT Phase I/IIa trial AN003 - The Journal of Immunology, 2011, 186, 107.14
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
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9
Demonstrated Long Term Immune Memory
AllerT (birch)
Allergen-Specific IgG4 Antibodies after 2nd and 4th Seasons in the Phase 1 Patients
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.
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www.anergis.ch
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10
Clinical Phase IIb Trial in 240 patients
AllerT (birch)
 Trial Design
 Placebo-controlled, double-blind, randomized multicenter (AN004T)
 Primary: combined symptom and medication score during the birch pollen season
Subject screening
Pre-seasonal treatment
5 injections / 2 months
Oct 2012 – Jan 2013
Nov 2012 – Mar 2013
Birch pollen season
Mar-Jun 2013
AllerT 100 µg* (N=79)
moderate to severe
allergy to birch pollen
AllerT 50 µg* (N=79)
Results
Q3
2013
Placebo (N=82)
Safety & Tolerability
Symptom & Medication Scores
Quality of Life
Immunology Markers
Scheduled doses: half of target dose on Day 1 followed by target dose on days 7, 14, 28 and 56
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11
Demonstrated Reduction of Allergy
Symptoms During Seasonal Exposure
Rhinoconjunctivitis Symptom and Medication Score daily - AllerT Phase IIb trial (birch allergy)
Placebo
AllerT
Placebo ______
50µg ______
100µg ______
Season start: the first of 3 consecutive days with at least 10 pollen grains/mm3
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12
Analyses of Efficacy Endpoints
Placebo-corrected Least-Square Means (ANCOVA) with 95% Confidence Interval
Rhinoconjunctivitis Symptom and Medication Score (Primary)
0.015
0.180
Rhinoconjunctivitis Quality of Life Score (Mini-RQLQ, Juniper et al., Secondary)
0.008
0.011
Results of the primary efficacy analysis on the RSMS during the entire birch pollen season in the modified Intent-to-Treat Population – p values from ANCOVA primary analysis. Least
square mean values for RSMS: 0.87 / 0.64 / 0.74.
Results of the secondary efficacy analysis on the Total Score of the Mini-RQLQ during the birch pollen season in the modified Intent-to-Treat Population
Not for distribution without approval from Anergis | July 2014
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13
Clinical Phase IIb Trial Conclusions
 AllerT is efficacious
 In a seasonal trial with natural allergen exposure
 Improvements in primary and secondary endpoints are clinically meaningful
 Improvements are similar to marketed 3-year AIT products
 AllerT is safe and well tolerated
 No anaphylactic shock or grade 3 immediate (< 30 min) systemic reaction
 AllerT 50 µg is as efficacious as AllerT 100 µg
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Next Steps
Anergis plans to proceed with the following projects
 AllerT (birch) Clinical Phase III in Europe and USA
 AllerR (ragweed) pre-IND through Clinical Phase I/IIa
 AllerDM (dust mites) pre-IND through Clinical Phase I/IIa
 Discovery of new COP Allergy Vaccines
with pharmaceutical partner(s) and investors
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
[email protected]
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The Future of Allergy Treatment:
COP Allergy Vaccines
Contact: [email protected]
Not for distribution without approval from Anergis | July 2014
www.anergis.ch
[email protected]
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