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 1 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 2 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 3 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 4 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 5 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 6 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 7 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 8 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 9 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 10 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 11 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 12 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 13 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 14 The Future of Allergy Treatment: COP Allergy Vaccines Not for distribution without approval from Anergis | Swiss Biotech Day - 9 April 2013 15
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