Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — Investor Presentation (January 2019)
62 slides from Dbv Technologies Sa's investor presentation, Jan 7, 2019
Slide 1: The Epicutaneous Immunotherapy Company
The Epicutaneous Immunotherapy Company January 2019 ©Genoskin Exhibit 99.1
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward looking statements including, but not limited to, statements concerning the outcome or success of DBV’s clinical trials; its ability to successfully gain regulatory approvals and commercialize products; its ability to successfully advance its pipeline o
Slide 3: Advancing novel skin immunotherapies for patients with food allergies
Advancing novel skin immunotherapies for patients with food allergies and other immunological diseases Limited innovation in the field of food allergies has left millions of patients underserved today We are focused on discovering, developing and commercializing our novel skin immunotherapy product
Slide 4: Building a Promising Pipeline of Viaskin Product Candidates
Building a Promising Pipeline of Viaskin Product Candidates DEVELOPMENT STAGE PROGRAM INDICATION DISCOVERY PRE-CLINICAL PHASE I PHASE II PHASE III Viaskin Peanut Peanut Allergy Viaskin Milk Cow’s Milk Protein Allergy Viaskin Egg Hen’s Egg Allergy Mechanistic Study Eosinophilic Esophagitis 5 Programs
Slide 5: EPIT: Unlocking the Immune Properties of the Skin with the Viaskin Patch
EPIT: Unlocking the Immune Properties of the Skin with the Viaskin Patch Image: ©Genoskin Dioszeghy V, et al. J Immunol. 2011;186:5629-5637. EPIT targets the immune system on intact skin Condensation chamber formed by Viaskin patch allows natural epidermal water loss to solubilize dry antigens Lange
Slide 6: Merging Science & Technology for Differentiated Drug Development
Merging Science & Technology for Differentiated Drug Development Applied Epicutaneously Electrospray: patented patch manufacturing technology that allows for precise antigen deposits without adjuvants Patented electrostatic patch with condensation chamber allows the antigen to penetrate upper layer
Slide 7: Where We Are Today: Preparing to Resubmit BLA for Viaskin Peanut
Where We Are Today: Preparing to Resubmit BLA for Viaskin Peanut Leadership team expanded and strengthened in January 2019 Key medical, manufacturing and regulatory changes implemented ahead of anticipated BLA resubmission for Viaskin Peanut Dr. Hugh Sampson to oversee scientific and medical strateg
Slide 8: Recent Leadership Expansion
Recent Leadership Expansion: Transitioning from Late-Stage Research to Potential Commercial-Stage Julie O’Neill Global Manufacturing Dr. Hugh Sampson CSO & Interim CMO Alan Kerr Head of Regulatory Affairs Appointed CSO in 2015 and interim CMO in 1Q 2019 Leading expert in food allergies and immunolog
Slide 9: Food Allergies: A Major Global Unmet Medical Need
Food Allergies: A Major Global Unmet Medical Need Every 7 minutes a child goes to the emergency room for an allergic reaction to food2 Each year, approximately 150 deaths are due to allergic reactions; most deaths occur in patients who are aware of their allergy3 Food allergies can cause severe, pot
Slide 10: Peanut Allergy: A Daily Burden for Patients and Families Worldwide
Peanut Allergy: A Daily Burden for Patients and Families Worldwide 10 Avoidance is difficult: 39% of peanut allergy patients experience an accidental exposure within ~1 year of diagnosis1 Many factors contribute to severity, making reactions unpredictable2 ? 1. Green T, et al. Pediatrics. 2006;120:1
Slide 11: Our Solution for a Hard-to-Treat Disease
Our Solution for a Hard-to-Treat Disease Contamination leading to peanut consumption is a serious threat1 Estimated detectable peanut residue ranges from 0.025-45mg of peanut protein2 Desensitization therapies could offer significant reduction of the risks associated with accidental exposures 1,3,4,
Slide 12: PEPITES Pivotal Phase III Trial Design
PEPITES Pivotal Phase III Trial Results for Viaskin Peanut Reported in 4Q17 Efficacy Endpoints Study Population Highly allergic patients ages 4-11 > 0.7 kU/ L peanut-specific IgE and ≥ 6mm or 8 mm SPT* wheal Reactive dose at M0 ≤ 300 mg peanut protein (i.e. approx 1 peanut) Treatment responder defin
Slide 13: PEPITES Results: Primary Efficacy Endpoint
PEPITES Results: Primary Efficacy Endpoint Shows Significant Treatment Benefit with Favorable Safety Favorable tolerability & safety profile reported Most AEs were mild to moderate application site reactions No cases of severe anaphylaxis No SAE imbalance (4.2% in Viaskin Peanut vs 5.1% in placebo)
Slide 14: PEPITES Results: Increase in Threshold Reactivity
PEPITES Results: Significant Increase in Threshold Reactivity to Peanut Protein Observed mBOCF = Modified Baseline Observation Carried Forward 1Davis, C et al, ACAAI 2018 #A303 Unique MoA increases protection to peanut without requiring major exposure to offending allergen No consumption of peanut d
Slide 15: Viaskin Peanut 250 µg Clinical Profile
Viaskin Peanut 250 µg Clinical Profile Patients treated with Viaskin Peanut 250 µg were only exposed to ~1 peanut via the skin after 3 years1,2 Favorable safety and tolerability observed to date No cases of severe anaphylaxis due to treatment reported Drop-out rate due to AEs < 2% after 12 months (P
Slide 16: Expanding to Toddlers: Part B of Phase III Study Ages 1-3
SPT: Skin Prick Test, ** ED: Eliciting Dose ,*** CRD: Cumulative Reactive Dose at Food Challenge 1. The primary analysis evaluating the difference between Viaskin Peanut 250 μg and placebo is defined by reaching a lower bound of the two-sided 95% confidence interval (CI) of ≥15% 2. An interim analys
Slide 17: Viaskin Milk: Phase II Study Identified Safe/Effective Dose
Viaskin Milk: Milk Allergy (CMPA) Phase II Study Identified Safe/Effective Dose for Children Pediatric Phase I/II USA & Canada Part A: 18 patients Part B: 180 patients M0 Phase I (Part A) Cohort at 150µg dose Cohort at 300µg dose Cohort at 500µg dose DSMB DSMB FDA & DSMB Placebo 300 µg 150 µg 500 µg
Slide 18: MILES Results: Viaskin Milk 300µg
MILES Results: Support Viaskin Milk 300µg as the Potential First Treatment for CMPA in Children 2-11 Response Rate (ITT*) Favorable safety, tolerability and compliance Overall discontinuation rate of 4.5% 1.5% dropout due to AEs Most AEs related to application site (mild to moderate) No severe anaph
Slide 19: DBV Technologies: Pioneering a New Class of Immunotherapy
DBV Technologies: Pioneering a New Class of Immunotherapy CEO Daniel Tassé joined DBV in November 2018 Key medical, manufacturing and regulatory leadership changes announced ahead of anticipated resubmission of BLA for Viaskin Peanut Phase III clinical program for Viaskin Peanut in children ages 4-1
Slide 20: DBV Technologies
Wy, dbv technologies
Slide 21: Viaskin Platform
Viaskin Platform
Slide 22: The Skin Has Important Immune Properties
Di Meglio P, et al. Immunity. 2011;35:857-869. Nestle FO, et al. Nat Rev Immunol. 2009;9:679-691. Senti G, et al. Allergy. 2011;66:798-809. Metz M, et al. Curr Opin Immunol. 2009;21:687-693. Langerhans cell Keratinocyte Epidermis The Skin Has Important Immune Properties Immune functions of the skin
Slide 23: Modular components, technology versatility
Modular components à technology versatility Highly scalable Broadly applicable platform Manufacturing capabilities In-house development and engineering of electrospray machines Development and engineering expertise at DBV [ES GEN4.0 machine] Proprietary & Patented Manufacturing Capabilities Develope
Slide 24: Core Innovation: Differentiated Electrospray Technology
Dose flexibility Biological API deposit between 20 and 500 µg/cm2 API stability Solid & soluble protein layer, no glue Homogeneous repartition of API Uniform delivery into skin Replicability High dosage control in each patch Bioavailability High solubility from electrostatic forces instead of glue E
Slide 25: Robust IP Portfolio: Core Technology, Broad MoAs & Specific Indications
Boost Vaccination Peanut Eczema Eosinophilic Esophagitis Hemophilia A Allergic March Electrospray Viaskin II Viaskin I CORE TECHNOLOGY EPIT Food allergies EPIT Allergy related diseases Epicutaneous vaccination Immuno Rebalancing Tolerance induction Epicutaneous Desensitization Epicutaneous Vaccinati
Slide 26: Viaskin Peanut Phase III Program: PEPITES & REALISE
Viaskin Peanut Phase III Program: PEPITES & REALISE
Slide 27: Measuring Efficacy: Double-Blind Placebo-Controlled Food Challenge
Measuring Efficacy: Double-Blind Placebo-Controlled Food Challenge Standardized GMP challenge matrix1 Standardized semi-logarithmic increase of peanut protein doses (DBPCFC2 as per PRACTALL3) Allergic symptoms are graded from a standardized published protocol4 Challenge stopped by clear objective sy
Slide 28: PEPITES Pivotal Phase III Trial Results Reported in 4Q17
PEPITES Pivotal Phase III Trial Results Reported in 4Q17 Efficacy Endpoints Study Population Highly allergic patients ages 4-11 > 0.7 kU/ L peanut-specific IgE and ≥ 6mm or 8 mm SPT* wheal Reactive dose at M0 ≤ 300 mg peanut protein (i.e. approx 1 peanut) Treatment responder definition Assessed usin
Slide 29: PEPITES Baseline Characteristics
PEPITES Baseline Characteristics: Highly Allergic Patient Population 356 Patients Randomized Active: 238 Placebo: 118 Peanut Eliciting Dose (mg) Median: 100 Mean: ~140 Medical History of Patients n % Asthma 169 47.5 Eczema/Atopic Dermatitis 218 61.2 Allergic Rhinitis 199 55.9 Polyallergic 305 85.7
Slide 30: PEPITES Results: Primary Efficacy Endpoint
PEPITES Results: Primary Efficacy Endpoint Shows Significant Treatment Benefit with Favorable Safety Favorable tolerability & safety profile reported Most AEs were mild to moderate application site reactions No cases of severe anaphylaxis No SAE imbalance (4.2% in Viaskin Peanut vs 5.1% in placebo)
Slide 31: PEPITES Results: Increase in Threshold Reactivity
PEPITES Results: Significant Increase in Threshold Reactivity to Peanut Protein Observed mBOCF = Modified Baseline Observation Carried Forward 1Davis, C et al, ACAAI 2018 #A303 Unique MoA increases protection to peanut without requiring major exposure to offending allergen No consumption of peanut d
Slide 32: PEPITES Results: Robust Immunological Changes
PEPITES Results: Robust Immunological Changes Support Treatment Effect p < 0.0001† p < 0.0001† p < 0.0001† n 238 232 229 224 n 117 116 112 109 n 238 231 229 224 n 117 116 111 110 p < 0.0001† p < 0.0001† p = 0.0421† ANCOVA=analysis of covariance; CI=confidence interval; ED=eliciting dose; PS-IgE=pean
Slide 33: JAMA Publication 2017: Long-term Extension Data
JAMA Publication 2017: Long-term Extension Data Shows Benefit Increases Over Time in Phase IIb Study Results shown for Viaskin Peanut 250 µg * 1 child discontinued (not related to Viaskin Peanut) ** 2 children discontinued (none related to Viaskin Peanut) Sampson et al. JAMA. 2017;318(18):1798-1809.
Slide 34: PEPITES Post-Hoc Analysis Using VIPES Responder Definition
PEPITES Post-Hoc Analysis Using VIPES Responder Definition Suggests Consistent Treatment Effect Observed from Phase II to Phase III Δ = 28.8% p < 0.0001 Δ = 21.7% p < 0.00001 % of Responders % of Responders n = 238 n = 118 Actual Reported Response Rate in PEPITES (%) PEPITES Response Rate Using the
Slide 35: Positive Phase III REALISE Results
Positive Phase III REALISE Results Support Regulatory Filings for Viaskin Peanut * SPT: Skin Prick Test Patients 4 to 11 with history of IgE-mediated reactions to peanut Including patients with severe anaphylaxis ≥ 14 kU/L peanut-specific IgE and ≥ 8 mm SPT* wheal Safety & Exploratory Endpoints Prim
Slide 36: Viaskin Peanut Phase II Program: VIPES, OLFUS-VIPES & COFAR6
Viaskin Peanut Phase II Program: VIPES, OLFUS-VIPES & COFAR6
Slide 37: VIPES: Dose-Finding Phase IIb Trial
VIPES: Dose-Finding Phase IIb Efficacy and Safety Trial M0 M12 M12 M24 M26 Placebo 50 µg 100 µg 250 µg VIPES Dose-finding 250 µg 221 stratified patients, 22 centers in US, Canada, France, Poland, and Netherlands OLFUS-VIPES Open Label Follow-Up Study M0 VIPES & OLFUS-VIPES Efficacy Study Population
Slide 38: VIPES: Patient Population Snapshot at Baseline
VIPES: Patient Population Snapshot at Baseline 221 patients randomized 113 Children (6-11) 73 Adolescents (12-17) & 35 Adults (18+) Highly allergic patients (median) Children = 30 mg Adolescents & Adults = 100 mg Very high IgE levels: > 100 kU/L 47% of Children 38% of All Patients Medical History of
Slide 39: VIPES: Phase IIb Results Published in JAMA
VIPES: Phase IIb Results Published in JAMA in November 2017 Primary endpoint met with Viaskin Peanut 250 µg Greatest response in children ages 6-11 (53.6% vs. 19.4%, p = 0.008) Increase in threshold reactivity of peanut protein showed a clear dose response with greatest benefit in the 250 µg arm In
Slide 40: VIPES: Primary Endpoint Met, Children Ages 6-11
VIPES: Primary Endpoint Met Focus On Children (Ages 6-11) Response rate in children across doses after 12 months % of Responders (95% CI) p = 0.008
Slide 41: VIPES: Peanut Consumption in Children
1,000 mg 1,500 mg 2,000 mg 1,121.0 mg Median = 135.0 Median = 0.0 Median = 114.5 Median = 400.0 570.0 mg 471.2 mg 60.8 mg Mean CRD Increase (95% CI) 4-5 peanuts p < 0.001 Placebo n = 31 100 µg n = 26 VIPES: Peanut Consumption In Children (Ages 6-11) Clear Dose Response, Clear Magnitude Of Effect * E
Slide 42: VIPES: Immunological Changes in Children
VIPES: Immunological Changes In Children (Ages 6-11) Supports Treatment Effect Peanut-specific IgE (kU/L) Peanut-specific IgG4 (mg/L)
Slide 43: VIPES: Primary Efficacy Endpoint Met, Phase III Dose
VIPES: Primary Efficacy Endpoint Met Identified Viaskin 250 µg As Phase III Dose Response rate across doses after 12 months % of Responders (95% CI) p = 0.01
Slide 44: VIPES: Adolescents & Adults High Placebo Response Rate
VIPES: Adolescents & Adults High Placebo Response Rate Distorts Analysis Patients aged 12-55 response rate across doses % of Responders (95% CI) p = 0.40
Slide 45: VIPES: Adolescents & Adults Changes From Baseline CRD
Patients aged 12-55 increase in baseline CRD at 12 months across doses 837.4 mg Median = 0.0 Median = 10.0 Median = 30.0 Median = 335.0 842.3 mg 619.2 mg 528.4 mg VIPES: Adolescents & Adults Changes From Baseline CRD Indicate Dose Response Trend Mean CRD Increase (95% CI) Placebo n = 25 100 µg n = 3
Slide 46: VIPES: Adolescents & Adults Immunological Changes
VIPES: Adolescents & Adults Immunological Changes Support Dose Response Trend Peanut-specific IgE (kU/L) Peanut-specific IgG4 (mg/L)
Slide 47: VIPES: Post Hoc Analysis Using PEPITES Responder Definition
VIPES: Post Hoc Analysis Using PEPITES Responder Definition % of Responders Reported Response Rate VIPES Response Rate Using the PEPITES Response Criteria p = 0.008 p = 0.0007 VIPES Children (6-11 years) - Viaskin 250 μg at M12 % of Responders
Slide 48: OLFUS-VIPES: Open-label Follow-up Trial
OLFUS-VIPES: Open-label Follow-up Trial To VIPES Extension Trial To Support Use Of Viaskin Peanut M0 M12 M12 M24 M26 Placebo 50 µg 100 µg 250 µg VIPES Dose-finding 250 µg 221 stratified patients, 22 centers in US, Canada, France, Poland, and Netherlands OLFUS-VIPES Open Label Follow-Up Study M0 *CRD
Slide 49: OLFUS-VIPES: Long-term Follow-up Data Key Conclusions
OLFUS-VIPES: Long-term Follow-up Data Key Conclusions Late Breaking Oral Presentation at AAAAI 2017 In children treated for three years with a 250 µg dose there was a trend of progressive response to treatment as measured by increased response rate, higher CRD* and serological changes Treatment bene
Slide 50: OLFUS-VIPES: Immunological Changes, Ages 6-11
OLFUS-VIPES: Immunological Changes, Ages 6-11 Median relative change = 100 x (Month xx – Baseline)/Baseline Viaskin Peanut 250 µg, n = 18 0 3 6 12 18 24 30 36 Months 100 50 0 -50 0 3 6 12 18 24 30 36 Months 4,000 3,000 2,000 1,000 500 Relative Change IgE Median ± IQ Relative Change IgG4 Median ± IQ
Slide 51: CoFAR6: Efficacy And Safety, NIAID Sponsored Phase II
CoFAR6: Efficacy And Safety – NIAID Sponsored Phase II 221 stratified patients, 22 centers in US, Canada, France, Poland, and Netherlands Enrollment n = 75 Entry OFC positive to cumulative dose of < 1044 mg peanut protein Randomization 1:1:1 Week 52 5044 mg OFC 250 mg Viaskin Peanut Week 130 5044 mg
Slide 52: CoFAR6: Primary Endpoint Was Met
CoFAR6: Primary Endpoint Was Met No SAEs or Epinephrine due to drug 96% compliance Primary endpoint met (p = 0.003) Significant age by treatment interaction ~1/3 of children treated with 250 µg were able to tolerate > 1,000 mg protein (~4 peanuts) Significant increase in IgG4 Jones SM, et al. J Alle
Slide 53: Viaskin Milk Phase II Program: MILES
Viaskin Milk Phase II Program: MILES
Slide 54: Viaskin Milk: Phase II Study Identified Safe/Effective Dose
Viaskin Milk: Milk Allergy (CMPA) Phase II Study Identified Safe/Effective Dose for Children Pediatric Phase I/II USA & Canada Part A: 18 patients Part B: 180 patients M0 Phase I (Part A) Cohort at 150µg dose Cohort at 300µg dose Cohort at 500µg dose DSMB DSMB FDA & DSMB Placebo 300 µg 150 µg 500 µg
Slide 55: MILES Patient Population at Baseline
MILES Patient Population at Baseline 198 patients randomized 152 Children (2-11) 46 Adolescents (12-17) CRD of Cow’s Milk Mean Children: 216.3 mg Adolescents: 222.0 mg Median Children: 144 mg Adolescents: 144 mg Medical history of patients n % Asthma 139 70.2 Atopic Dermatitis 139 70.2 Allergic Rhin
Slide 56: MILES Results: Viaskin Milk 300µg
MILES Results: Support Viaskin Milk 300µg as the Potential First Treatment for CMPA in Children 2-11 Response Rate (ITT*) Favorable safety, tolerability and compliance Overall discontinuation rate of 4.5% 1.5% dropout due to AEs Most AEs related to application site (mild to moderate) No severe anaph
Slide 57: MILES Results: Improvement in Threshold Reactivity
MILES Results: Significant Improvement in Threshold Reactivity with Viaskin Milk 300µg in Children 2-11 *Among patients with evaluable CRD assessment at Month 12. †Note, not all subjects underwent a Month-12 OFC: 1 subject in PBO, 1 subject in VM150 µg, 2 in VM300 µg, and 2 in VM500 µg did not repor
Slide 58: MILES Results: All Dose Cohorts Response Rate
MILES Results: All Dose Cohorts At Month-12 Response Rate, Overall Population (ITT*) Response Rate (PP) % of Responders (95% CI) p = 0.682 p = 0.085 p = 0.641 % of Responders (95% CI) p = 0.522 p = 0.027 p = 0.649 Response Rate (ITT*) *Missing data: failure imputation (considered as non-responders)
Slide 59: MILES Results: All Dose Cohorts CRD
MILES Results: All Dose Cohorts At Month-12 CRD, Overall Population (ITT) Mean CRD Increase at M12 vs Baseline, mg* Mean Increase in CRD p = 0.736 p = 0.008 p = 0.189 Median 100 mg Median 300 mg Median 400 mg Median 93 mg n = 39 n = 37 n = 36 n = 34 *Among patients with evaluable CRD assessment at M
Slide 60: MILES Immunologic Data: sIgG4
MILES Immunologic Data in Children 2-11 (ITT): Significant Immunomodulation with Viaskin Milk sIgG4 casein, mg/L sIgG4 α-lactalbumin, mg/L sIgG4 β-lactoglobulin, mg/L p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 Geometric Mean (90% CI) Geometric Mean (90%
Slide 61: MILES Immunologic Data: sIgE
MILES Immunologic Data in Children 2-11 (ITT): Significant Immunomodulation with Viaskin Milk P-values obtained from repeated-measures ANCOVA model including treatment group, timepoint, treatment-by-timepoint interaction and M0 value as fixed effect, using log-transformed data; ITT=Intent-to-Treat p
Slide 62: DBV Technologies
Wy, dbv technologies
DBV Technologies — Investor Presentation (January 2019) on 6ix