Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — 2015 American Academy of Allergy, Asthma & Immunology Meeting
26 slides from Dbv Technologies Sa's conference presentation, Feb 25, 2015
Slide 1: A Novel Immunotherapy Pathway
2015 American Academy of Allergy, Asthma & Immunology Meeting Investor Update - February 2015 A Novel Immunotherapy Pathway Exhibit 99.2
Slide 2: Become the Leader in Food Allergy Treatments; Advance Development in Immunology & Vaccines
Become the Leader in Food Allergy Treatments Advance Development in Immunology & Vaccines The Epicutaneous Immunotherapy Company Our Approach in the Next 5 Years Clinically validated in largest Phase IIb Deliver superior products with clear regulatory path Build commercial platform for multiple prod
Slide 3: Become the Leader in Food Allergy Treatments
Current Targets New Targets Become the Leader in Food Allergy Treatments Our Commitment: Launching a New Product Every Two Years Focus our Development Allergies Peanut Milk Hen’s Egg Tree Nuts Shellfish Eosinophilic Esophagitis (EoE) Eosinophilic colitis & gastritis Eczema Prophylaxis Allergic march
Slide 4: Advance Development in Immunology & Vaccines
Current Targets New Targets Advance Development in Immunology & Vaccines Our Commitment: 3 to 5 Products in the Clinic by 2020 Focus our Development Autoimmune Asthma prevention r. Hemophilia A Celiac Disease Diabetes type I Inflammatory EoE IBD Immuno-Oncology Vaccines Pertussis boost RSV Hepatitis
Slide 5: Standalone strategy, rapid advancement to PoC
Standalone strategy, rapid advancement to PoC Acceleration of Immunology & Vaccines Development Creation of Focused Therapeutic Teams Attract Senior Advisors Leverage KOL / leading experts Staff DBV Therapeutic Teams Drive in-house development Leverage Academic Centers of Excellence Benefit from exp
Slide 6: Where we are today / Upcoming Milestones
Where we are today Upcoming Milestones o OLFUS-VIPES Viaskin Peanut year 2 data o Launch of Viaskin Peanut Phase III – Peanut EPIT Efficacy & Safety (“PEPITES”) o EoE clinical trial initiation with Viaskin Milk o Pertussis enters clinic, pending regulatory greenlight o CoFAR6 1-year study completed
Slide 7: VIPES Phase IIb Data Presentation
VIPES Phase IIb Data Presentation 2015 American Academy of Allergy, Asthma & Immunology Meeting Investor Update - February 2015
Slide 8: Phase IIb VIPES & OLFUS-VIPES study design
VIPES Efficacy Endpoints VIPES Study Population Evaluation Phase IIb - VIPES & OLFUS-VIPES Design Approved by FDA Stratified study, enrolling subjects aged 6-55 Highly allergic patients o > 0.7 kUI/ L peanut-specific IgE and mm SPT wheal o Peanut reactive dose at M0 mg peanut protein (ie. approx pea
Slide 9: VIPES was Successfully Designed and Executed
Placebo N (%) 50 ug N (%) 100 ug N (%) 250 ug N (%) Total N (%) VIPES was Successfully Designed and Executed Low Drop-Outs and Only a Few Deviations Screened Set Randomized 56 (100.0) 53 (100.0) 56 (100.0) 56 (100.0) 221 (100.0) Did not complete the study o/w adverse event 2 (3.6) 2 (3.8) 7 (12.5) 2
Slide 10: Patient Characteristics
a n Placebo 56 50 µg 53 100 µg 56 250 µg 56 Total 221 Patient Characteristics Highly Peanut Allergic Subjects, Major Pediatric Focus Age (years) b Overall (6-55) Mean (SD) 12.5 (6.84) 12.3 (6.72) 13.9 (6.66) 13.6 (7.48) 13.1 (6.92) Children (6-11) n (%) 31 (55.4) 28 (52.8) 26 (46.4) 28 (50.0) 113 (5
Slide 11: Peanut Reactive Dose at Baseline in VIPES
Peanut Reactive Dose at Baseline in VIPES Highly Allergic Patients Median peanut protein ED: o o Children: 30 mg Adolescents & Adults: 100 mg Children Adolescents/Adults
Slide 12: VIPES Highlights Viaskin's Patient-Friendly and Safety Profile
Placebo 56 50 µg 53 100 µg 56 250 µg 56 Total 221 VIPES Highlights Viaskin’s Patient-Friendly and Safety Profile High Compliance Rate, Low Drop-outs Overall compliance (%) Median 97.0 96.9 97.8 98.7 97.6 Drop-out not related to Viaskin n (%) (3.6) (3.8) (10.7) (3.6) (5.4) Drop-out related to Viaskin
Slide 13: Primary Efficacy Endpoint Met in All Subjects
50.0% Primary Efficacy Endpoint Met in All Subjects Statistically Significant Study Response rate accross doses after 12 months p= 0.0108 p= 0.1074 p= 0.0292 25.0% 45.3% 41.1% 0% 10% 20% 30% 40% 50% 60% 70% Placebo n = 56 50 µg n = 53 100 µg n = 56 250 µg n = 56
Slide 14: Children: Statistically Significant in all three Doses
53.6% Children Statistically Significant in all three Doses Response rate in Children accross doses after 12 months p= 0.0076 p= 0.0453 p= 0.0035 19.4% 57.1% 46.2% 0% 10% 20% 30% 40% 50% 60% 70% 80% Placebo n = 31 50 µg n = 28 100 µg n = 26 250 µg n = 28
Slide 15: Children: 1,000 mg Criteria Magnifies Efficacy vs Placebo
32.1% Children 1,000 mg Criteria Magnifies Efficacy vs Placebo Proportion of Children who reached 1,000 mg ED after 12 months p = 0.0177 p = 0.0324 p = 0.0363 6.5% 28.6% 30.8% 0% 5% 10% 15% 20% 25% 30% 35% Placebo n = 31 50 µg n = 28 100 µg n = 26 250 µg n = 28
Slide 16: Children: Increased Criteria Stringency Supports Strong Efficacy
32.1% Children Increased Criteria Stringency Supports Strong Efficacy Proportion of strong responders in Children (both x10 and 1,000 mg increase in ED) p = 0.0005 p = 0.0025 p = 0.0196 # of Children with no objective symptoms at M12 food challenge’s highest dose 0.0% 17.9% 26.9% 0% 5% 10% 15% 20% 2
Slide 17: Children: Clear Dose Response, Clear Magnitude of Effect
Children Clear Dose Response, Clear Magnitude of Effect Increase in CRD in Children after 12 months (Mean and Median)* 1.000 mg 500 mg 0 mg 1.500 mg 2.000 mg 1,121.0 mg Median = 135.0 Median = 0.0 Median = 214.5 Median = 400.0 p < 0.001 p = 0.007 p = 0.003 617.5 mg 471.2 mg 62.8 mg * Excluding missi
Slide 18: Children: Clear Dose Response, Clear Magnitude of Effect
Children Clear Dose Response, Clear Magnitude of Effect Increase in CRD in Children after 12 months (Mean and Median) 1.000 mg 500 mg 0 mg 1.500 mg 2.000 mg 1,121.0 mg Median = 135.0 Median = 0.0 Median = 114.5 Placebo n = 31 Median = 400.0 50 µg n = 28 100 µg n = 26 250 µg n = 28 p < 0.001 p < 0.01
Slide 19: Children: Immunological Changes Confirm Treatment Effect
Children Immunological Changes Confirm Treatment Effect Peanut-specific IgG4 (mg/L) Peanut-specific IgE (kU/L)
Slide 20: Adolescents & Adults: High Placebo Response Rate Distorts Analysis
46.4% Subjects aged 12-55 response rate across doses Adolescents & Adults High Placebo Response Rate Distorts Analysis p= 0.3998 p= 0.7812 p= 1.0000 32.0% 32.0% 36.7% 0% 10% 20% 30% 40% 50% 60% 70% Placebo n = 25 50 µg n = 25 100 µg n = 30 250 µg n = 28
Slide 21: Adolescents & Adults: Changes from Baseline CRD Indicate Dose Response Trend
Adolescents & Adults Changes from Baseline CRD Indicate Dose Response Trend 500 mg 1.000 mg 0 mg 1.500 mg 837.4 mg Median = 0.0 Median = 10.0 Median = 30.0 Median = 300.0 842.3 mg 619.2 mg 528.4 mg Subjects aged 12-55 increase in baseline CRD at 12 months across doses Placebo n = 25 50 µg n = 25 100
Slide 22: Adolescents & Adults: Immunological Changes Support Dose Response Trend
Adolescents & Adults Immunological Changes Support Dose Response Trend Peanut-specific IgG4 (mg/L) Peanut-specific IgE (kU/L)
Slide 23: Conclusion
Conclusion VIPES: largest, multicenter RCT in peanut allergy Excellent compliance Appears safe in all populations Primary efficacy endpoint met In Children subgroup: Statistical Efficacy demonstrated for all doses Dose effect on the cumulative reactive quantity of peanut, with stronger magnitude for
Slide 24: Timeline
T D Timeline Targeting First Patient-in into Phase III Q4 2015 o 1 year study with more than 12 visits per patient: long treatment o Dose finding with 4 arms o Each arm stratified by population age Top line data disclosed 2 months T+ 3 months Full CSR All QC’ed tables generated (180 TFLs) 2 months E
Slide 25: Key Opinion Leaders Roundtable
Key Opinion Leaders Roundtable 2015 American Academy of Allergy, Asthma & Immunology Meeting Investor Update - February 2015
Slide 26: Thank You
Thank You Dr. Sampson, Dr. Spergel, Dr. Brown-Whitehorn, Dr. Dupont Dr. Hugh Sampson is the Kurt Hirschhorn, M.D./ Children’s Center Foundation Professor of Pediatrics and the Dean for Translational Biomedical Sciences at the Icahn School of Medicine at Mount Sinai. He is the Director of the Jaffe F
DBV Technologies — 2015 American Academy of Allergy, Asthma & Immunology Meeting on 6ix