Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — Investor Presentation (December 2018)
56 slides from Dbv Technologies Sa's investor presentation, Dec 6, 2018
Slide 1: The Epicutaneous Immunotherapy Company
The Epicutaneous Immunotherapy Company December 2018 ©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 food allergies
Advancing novel skin immunotherapies for patients with food allergies and other immunological diseases Over the last two decades, limited innovation in the food allergy field has left millions of patients significantly underserved today We are focused on discovering, developing and commercializing o
Slide 4: Promising Pipeline of Product Candidates
Promising Pipeline of 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 Undisclosed Diagno
Slide 5: Recent Viaskin Peanut Updates: BLA Submitted to FDA in October 2018
Recent Viaskin Peanut Updates: BLA Submitted to FDA in October 2018 Fast track for Viaskin Peanut Breakthrough for Viaskin Peanut PEPITES Phase III data REALISE Phase III data Breakthrough and fast track designations potentially allow for expedited review. Based on recent communications with FDA, de
Slide 6: Recent Viaskin Peanut Updates: Scaled-up GMP manufacturing
Recent Viaskin Peanut Updates: BLA Submitted to FDA in October 2018 Scaled-up GMP manufacturing process in place Plans in place for additional machine post-launch Annual production capacity of 30 million Viaskin Peanut patches per GEN4.0 machine Fully Integrated Manufacturing Process API dry powder:
Slide 7: Viaskin Technology: Building a Transformative Immunotherapy Platform
Viaskin Technology: Building a Transformative Immunotherapy Platform Pioneering a new class of immunotherapy Merging science and technology for differentiated drug development Advancing transformative treatments for large, underserved patient populations Food allergies and related allergic diseases
Slide 8: 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 9: EPIT: Pioneering a New Class of Immunotherapy
Transmission of immunogenic information, with no allergen passage to the bloodstream Solubilized antigen is captured by Langerhans cells in the epidermis Targeting the immune system on intact skin EPIT: Pioneering a New Class of Immunotherapy Image: ©Genoskin Dioszeghy V, et al. J Immunol. 2011;186:
Slide 10: Merging Science & Technology for Differentiated Drug Development
Merging Science & Technology for Differentiated Drug Development Applied Epicutaneously Electrospray: patented manufacturing tool that allows for precise antigen deposits without adjuvants Patented electrostatic patch with condensation chamber allows the antigen to penetrate upper layer of epidermis
Slide 11: Proprietary & Patented Manufacturing Capabilities Developed by DBV
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 12: 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 13: 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 14: Food Allergies: Addressing an Urgent Unmet Medical Need
Food Allergies: Addressing an Urgent 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 50% of peanut-allergic patient
Slide 15: No Significant Innovation in Food Allergy Immunotherapy
In Last Several Decades, No Significant Innovation in Food Allergy Immunotherapy Safety is paramount: ingesting small quantities of offending allergen can cause life-threatening reactions After several decades, these patients are still underserved: there are no approved treatments today Current dise
Slide 16: 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 17: 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 18: PEPITES Baseline Characteristics: Highly Allergic Patient Population
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 19: 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 20: PEPITES Results: Increase in Threshold Reactivity to Peanut Protein
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 21: 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 22: 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 23: 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 24: Positive Phase III REALISE Results Support Regulatory Filings
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 25: Viaskin Peanut Profile Aligned with Patients and HCPs Objectives
Viaskin Peanut’s Profile Aligned with Patients and HCPs Treatment Objectives 1.DBV Internal Market Research; survey of allergists (100) in 1Q 2017 and 4Q 2017; survey of physicians (500), caregivers/children (360): 2016-2017, 1Q 2015 survey of 240 caregivers of peanut allergic children, DBV Internal
Slide 26: Balancing Risk-Benefit to Treat Peanut-Allergic Patients
Balancing Risk-Benefit to Treat Peanut-Allergic Patients in Real-Life Unmet medical need today is to de-risk patients when accidentally exposed to peanut Contamination of foods with trace amounts of peanut is a daily threat Baseline sensitivity in our clinical trials was less than ~1 peanut Viaskin
Slide 27: Expanding the Franchise: Phase III Trial in Toddlers
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 28: Expanding the Franchise: Milk Allergy Phase II Study
Expanding the Franchise: 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 15
Slide 29: 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 30: MILES Results: Viaskin Milk 300µg in Children 2-11
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 31: 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 32: Upcoming Milestones
Upcoming Milestones CHOP to release SMILEE Phase IIa pilot trial results for Viaskin Milk in Eosinophilic Esophagitis (EoE) Potential acceptance of BLA filing for Viaskin Peanut in children ages 4-11 2H 2018 2019 Potential US launch of Viaskin Peanut in children ages 4-11 Potential MAA submission fo
Slide 33: DBV Technologies: Pioneering a New Class of Immunotherapy
DBV Technologies: Pioneering a New Class of Immunotherapy CEO Daniel Tassé joined DBV on November 29, 2018 Viaskin Peanut BLA submitted in October 2018; targeting 2019 U.S. launch Results from Viaskin Peanut Phase III clinical trials: PEPITES & REALISE Fully-scalable, launch-ready manufacturing capa
Slide 34: dbv
Wy, dbv technologies
Slide 35: 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 36: VIPES: Dose-Finding Phase IIb Efficacy and Safety 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 37: 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 38: 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 39: VIPES: Primary Endpoint Met, Focus On Children
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 40: 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 41: 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 42: VIPES: Primary Efficacy Endpoint Met
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 43: 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 44: 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 45: 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 46: 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 47: OLFUS-VIPES: Open-label Follow-up Trial To VIPES
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 48: 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 49: 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 50: 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 51: 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 52: MILES Results: All Dose Cohorts At Month-12 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 53: MILES Results: All Dose Cohorts At Month-12 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 54: MILES Immunologic Data in Children 2-11: 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 55: MILES Immunologic Data in Children 2-11: 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 56: dbv
Wy, dbv technologies
DBV Technologies — Investor Presentation (December 2018) on 6ix