Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — Investor Presentation (October 2019)
62 slides from Dbv Technologies Sa's investor presentation, October 2019
Slide 1: The Epicutaneous Immunotherapy Company
The Epicutaneous Immunotherapy Company October 2019 ©Genoskin
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: Where We Are Today
Where We Are Today Viaskin Peanut BLA accepted for review by U.S. FDA on October 4, 2019 ✓ Target action date provided by FDA of August 5, 2020 ✓ We believe we remain on track to potentially offer this treatment for peanut-allergic children in 2H 2020 Leadership team expanded and strengthened throug
Slide 4: Pioneering a New Class of Immunotherapy
Pioneering a New Class of Immunotherapy • 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 commerc
Slide 5: 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 FDA Review Ages 4-11 (Breakthrough Therapy and Fast Track Designation*) Viaskin Peanut Peanut Allergy Ages 1-3 Adolescents & Adults Cow’s Milk Protein Vi
Slide 6: EPIT: Unlocking the Immune Properties of the Skin with the Viaskin Patch
EPIT: Unlocking the Immune Properties of the Skin with the Viaskin Patch EPIT targets the immune system on intact skin • Condensation chamber formed by Viaskin patch allows natural epidermal water loss to solubilize dry antigens • Langerhans cells capture solubilized antigen in the epidermis • Kerat
Slide 7: Merging Science & Technology for Differentiated Drug Development
Merging Science & Technology for Differentiated Drug Development EPIT Activates the Immune System Through Intact Skin Electrospray: patented patch manufacturing technology that allows for precise antigen deposits without Patented electrostatic patch adjuvants with condensation chamber allows the ant
Slide 8: Food Allergies: A Major Global Unmet Medical Need
Food Allergies: A Major Global Unmet Medical Need ~8% of children in the U.S. • Every 7 minutes a child goes to the emergency room for an allergic reaction to food2 or ~2 children in every classroom, have a food allergy1 • Each year, approximately 150 deaths are due to allergic reactions; most death
Slide 9: Peanut Allergy: A Daily Burden for Patients and Families Worldwide
Peanut Allergy: A Daily Burden for Patients and Families Worldwide Avoidance is difficult: 39% of peanut allergy patients experience an accidental 73% of caregivers are most concerned with exposure within ~1 year of diagnosis1 accidental exposure to peanuts in their kids’ daily life4 ? Many factors
Slide 10: Our Solution for a Hard-to-Treat Disease
Our Solution for a Hard-to-Treat Disease • Contamination leading to peanut consumption Viaskin Peanut utilizes the skin’s immune is a serious threat1 properties, which amplifies minimal • Estimated detectable peanut residue ranges allergen exposure from 0.025-45mg of peanut protein2 • Desensitizatio
Slide 11: Viaskin Peanut Leads Our Food Allergy Pipeline
Viaskin Peanut Leads Our Food Allergy Pipeline • Patients treated with Viaskin Peanut 250 µg were only exposed to ~1 peanut via the skin after 3 years1,2 • Favorable tolerability observed in clinical trials of Viaskin Peanut to date − No cases of severe anaphylaxis due to treatment reported − Drop-o
Slide 12: PEPITES Pivotal Phase III Trial Results (Fleischer, JAMA 2019)
PEPITES Pivotal Phase III Trial Results (Fleischer, JAMA 2019) Placebo Pivotal Global Randomized DBPC Phase 3 Trial Screening • 356 children aged 4 to 11 years 250 µg • 31 study locations (United States, Canada, Australia, Germany, and Ireland) M0 M12 NCT02636699 Randomization* DBPCFC Primary Endpoi
Slide 13: Trial Population Included Patients with Multiple Allergic Conditions
Trial Population Included Patients with Multiple Allergic Conditions (Fleischer, JAMA 2019) • Patient population included a high percentage of subjects with additional allergic conditions 100% Medical History of Patients* 356 Patients Randomized, n (%) • Active (VP250 μg): 238 (67%) 85.7% • Placebo:
Slide 14: Primary Efficacy Outcome Showed Statistically Significant Treatment Effect
Primary Efficacy Outcome Showed Statistically Significant Treatment Effect (Fleischer, JAMA 2019) • After 12 months, a significantly larger Response Rate (ITT) percentage of participants responded to 40 P<0.001 Viaskin Peanut treatment vs placebo patch Percent of Responders (%) 35 35.3% vs 13.6% (P<
Slide 15: Cumulative Reactive Dose Increased Over 12 Months of Treatment
Cumulative Reactive Dose (CRD) Increased Over 12 Months of Treatment (Fleischer, JAMA 2019) • A difference in CRD was observed 1200 CRD After 12 Months between the active and placebo P<0.001* Median groups (P<0.001*) 1000 905.7 Mean (95% CI) (mg) 800 • The median CRD in participants in the 600 Viask
Slide 16: Changes in Biomarkers Support Immunomodulatory Effect of Viaskin Peanut
Changes in Biomarkers Support Immunomodulatory Effect of Viaskin Peanut (Fleischer, JAMA 2019) • Levels of IgE increased initially then returned to baseline • Treatment groups were distinguishable based on levels of peanut-specific IgG4 as early as month 3 – Levels of IgG4 steadily increased in Vias
Slide 17: Increased ED in Majority of Participants Treated with Viaskin Peanut
Increased ED in Majority of Participants Treated with Viaskin Peanut (Fleischer, JAMA 2019) • In a post-hoc analysis, 53.1% of 100% Change in ED in Children 4 to 11 years of age1,3† subjects on Viaskin Peanut 250 µg >4x more likely in ED Increase increased their baseline ED from 28.0% Viaskin Peanut
Slide 18: High Adherence and Low Discontinuation Due to TEAEs
High Adherence and Low Discontinuation Due to TEAEs (Fleischer, JAMA 2019) • 89.9% of all subjects completed the study, with similar discontinuation rates observed between treatment groups (10.5% in Viaskin® Peanut group, 9.3% in placebo group) • Treatment adherence* was high (98.5%) across the tota
Slide 19: Low Rates of Treatment-Related Serious AEs
Low Rates of Treatment-Related Serious AEs (Fleischer, JAMA 2019) • Viaskin Peanut 250 µg: 12 SAEs* in 10 Serious AEs* participants (4.2%); Placebo: 6 SAEs in 6 10% participants (5.1%) Placebo, n=118 Viaskin Peanut 250 µg, n=238 – 4 SAEs in 3 Viaskin Peanut participants 8% considered related to trea
Slide 20: Expanding to Toddlers: Part B of Phase III Study in Ages 1-3
Expanding to Toddlers: Part B of Phase III Study of VP in Ages 1-3 Initiated in October 2018 Positive DSMB from Part A: No safety concerns identified Part B: ~350 additional patients Part A: 51 patients randomized Highest safe dose (250 µg) Placebo (n = ~10) n = ~233 EPOPEX 100 µg (n = ~20) Open Lab
Slide 21: Viaskin Milk: Milk Allergy Phase II Study Identified Safe/Effective Dose
Viaskin Milk: Milk Allergy (CMPA) Phase II Study Identified Safe/Effective Dose for Children Phase I (Part A) Phase II (Part B) Open Label Cohort at 500µg dose Placebo DSMB FDA & 150 µg Pediatric Phase I/II 300 µg*** DSMB USA & Canada Cohort at 300 µg Part A: 18 patients 300µg dose 500 µg Part B: 18
Slide 22: MILES Results: Viaskin Milk 300µg as Potential First Treatment for CMPA
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 p = 0.042 p = 0.733 • Overall discontinuation rate of 4.5% p > 0.999 – 1.5% dropout due to AEs • Most AEs related to application sit
Slide 23: DBV Technologies: Pioneering a New Class of Immunotherapy
DBV Technologies: Pioneering a New Class of Immunotherapy • Leadership team expanded and strengthened in 2019 • BLA for Viaskin Peanut in children ages 4-11 accepted for review in October 2019, with target action date of August 5, 2020 • Phase III clinical program for Viaskin Peanut in children ages
Slide 24: dbv
WZ dbv technologies
Slide 25: Appendix
APPENDIX
Slide 26: Viaskin Platform
Viaskin Platform
Slide 27: The Skin Has Important Immune Properties
The Skin Has Important Immune Properties • Immune functions of the skin include – Responding to trauma, toxins, and infectious agents – Maintaining self-tolerance, preventing allergy, Keratinocyte and inhibiting autoimmunity Epidermis • Keratinocytes Langerhans – Distinguish pathogens from harmless
Slide 28: Proprietary & Patented Manufacturing Capabilities Developed by DBV
Proprietary & Patented Manufacturing Capabilities Developed by DBV • Modular components → technology versatility – Highly scalable – Broadly applicable platform • Manufacturing capabilities – In-house development and engineering of electrospray machines – Development and engineering expertise [ES GE
Slide 29: Core Innovation: Differentiated Electrospray Technology
Core Innovation: Differentiated Electrospray Technology • Dose flexibility Regulated flow of dissolved antigen – Biological API deposit between 20 and 500 µg/cm2 • API stability Capillary – Solid & soluble protein layer, no glue nozzle High voltage • Homogeneous repartition of API (up to 20,000 V) –
Slide 30: Robust IP Portfolio: Core Technology, Broad MoAs & Specific Indications
Robust IP Portfolio: Core Technology, Broad MoAs & Specific Indications Allergic March Eosinophilic Esophagitis Broad geographic applications Milk EPIT EPIT Food allergies Allergy related • USA, Europe, Australia, diseases Canada Peanut Eczema CORE TECHNOLOGY Long patent protection Epicutaneous Dese
Slide 31: Viaskin Peanut Phase III Program: PEPITES & REALISE
Viaskin Peanut Phase III Program: PEPITES & REALISE
Slide 32: Measuring Efficacy: Double-Blind Placebo-Controlled Food Challenge
Measuring Efficacy: Double-Blind Placebo-Controlled Food Challenge Baseline 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg Month 12* 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg 1,000 mg 2,000 mg DBPCFC: Efficacy Outcome Scoring with Standardized Challenge Matrix CATEGORIES OBJECTIVE SYMPTOMS GRADE SUBJECTIVE SYMPTOMS
Slide 33: 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 Actual Reported Response PEPITES Response Rate Using Rate in PEPITES (%) the VIPES Response Criteria 50 50 45.8% LCL 12.4 LCL 18.9 UCL 29.8 UCL 37.4 40 40 35.3% % of Re
Slide 34: Positive Phase III REALISE Results Support Regulatory Filings
Positive Phase III REALISE Results Support Regulatory Filings for Viaskin Peanut Positive 6-month safety results confirmed the safety and tolerability profile observed in PEPITES, VIPES and CoFAR6 Placebo 393 peanut allergic children 250 µg 32 centers in North America 250 µg Safety Safety Safety Saf
Slide 35: Viaskin Peanut Phase II Program: VIPES, OLFUS-VIPES & COFAR6
Viaskin Peanut Phase II Program: VIPES, OLFUS-VIPES & COFAR6
Slide 36: VIPES: Dose-Finding Phase IIb Efficacy and Safety Trial
VIPES: Dose-Finding Phase IIb Efficacy and Safety Trial (Sampson, JAMA 2017) Placebo 221 stratified patients, 22 50 µg 250 µg centers in US, Canada, France, 100 µg Poland, and Netherlands 250 µg M0 M12 M0 M12 M24 M26 VIPES OLFUS-VIPES Dose-finding Open Label Follow-Up Study Clinical Trial Patient Po
Slide 37: VIPES: Patient Population Snapshot at Baseline
VIPES: Patient Population Snapshot at Baseline 221 patients randomized 40 38 39 • 113 Children (6-11) • 73 Adolescents (12-17) & 35 Adults (18+) Randomized Patients (n) Highly allergic patients (median) 23 • Children = 30 mg 17 18 • Adolescents & Adults = 100 mg 13 13 Very high IgE levels: > 100 kU/
Slide 38: VIPES: Phase IIb Results Key Conclusions
VIPES: Phase IIb Results Key Conclusions • 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 the childre
Slide 39: VIPES: Primary Endpoint Met Focus On Children (Ages 6-11)
VIPES: Primary Endpoint Met Focus On Children (Ages 6-11) Response rate in children across doses after 12 months p = 0.008 80% 70% % of Responders (95% CI) 60% 50% 40% 30% 57.1% 53.6% 20% 46.2% 10% 19.4% 0% Placebo 50 µg 100 µg 250 µg n = 31 n = 28 n = 26 n = 28 39
Slide 40: VIPES: Peanut Consumption In Children, Clear Dose Response
VIPES: Peanut Consumption In Children (Ages 6-11) Clear Dose Response, Clear Magnitude Of Effect Increase in CRD in children after 12 months (Mean and Median)* p < 0.001 2,000 mg 4-5 peanuts 1,500 mg Mean CRD Increase (95% CI) 1,121.0 mg 1,000 mg 570.0 mg 471.2 mg 500 mg Median = 400.0 60.8 mg Media
Slide 41: VIPES: Immunological Changes In Children Supports Treatment Effect
VIPES: Immunological Changes In Children (Ages 6- 11) Supports Treatment Effect Peanut-specific IgE (kU/L) Peanut-specific IgG4 (mg/L) 400 15 200 10 100 7 x 1 9 .1 6 x 2 .5 x 1 .6 5 50 x 3 .1 4 x 1 .3 3 0 x 5 .5 2 x 7 .2 1 x 1 .3 -5 0 0 -5 0 -1 0 0 -1 0 3 6 9 12 M T H 0 3 6 9 12 M T H 41
Slide 42: VIPES: Primary Efficacy Endpoint Met Identified Viaskin 250 µg As Phase III Dose
VIPES: Primary Efficacy Endpoint Met Identified Viaskin 250 µg As Phase III Dose Response rate across doses after 12 months p = 0.01 70% 60% % of Responders (95% CI) 50% 40% 30% 45.3% 50.0% 20% 41.1% 10% 25.0% 0% Placebo 50 µg 100 µg 250 µg n = 56 n = 53 n = 56 n = 56 42
Slide 43: VIPES: Adolescents & Adults High Placebo Response Rate Distorts Analysis
VIPES: Adolescents & Adults High Placebo Response Rate Distorts Analysis Patients aged 12-55 response rate across doses p = 0.40 70% 60% % of Responders (95% CI) 50% 40% 30% 20% 46.4% 36.7% 10% 32.0% 32.0% 0% Placebo 50 µg 100 µg 250 µg n = 25 n = 25 n = 30 n = 28 43
Slide 44: VIPES: Adolescents & Adults Changes From Baseline CRD
VIPES: Adolescents & Adults Changes From Baseline CRD Indicate Dose Response Trend Patients aged 12-55 increase in baseline CRD at 12 months across doses 1,500.0 mg Mean CRD Increase (95% CI) 1,000.0 mg 842.3 mg 837.4 mg 619.2 mg 528.4 mg 500.0 mg Median = 335.0 Median = 10.0 Median = 0.0 Median = 3
Slide 45: VIPES: Adolescents & Adults Immunological Changes Support Dose Response Trend
VIPES: Adolescents & Adults Immunological Changes Support Dose Response Trend Peanut-specific IgE (kU/L) Peanut-specific IgG4 (mg/L) 400 4 300 3 200 2 100 100 1 .5 x 2 .0 M e d ia n IQ R M e d ia n IQ R 1 .0 50 x 5 .3 x 3 .5 x 2 .0 x 1 .7 0 .5 x 3 .7 x 1 .4 0 x 1 .6 0 .0 0 3 6 9 12 M TH 0 3 6 9
Slide 46: VIPES: Post Hoc Analysis Using PEPITES Responder Definition
VIPES: Post Hoc Analysis Using PEPITES Responder Definition VIPES Children (6-11 years) - Viaskin 250 μg at M12 Reported Response Rate VIPES Response Rate Using the PEPITES Response Criteria 80% p = 0.008 80% p = 0.0007 70% 70% 60% 60% % of Responders % of Responders 50% 50% 40% 40% 30% 30% 53.6% 20
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 Placebo 221 stratified patients, 22 50 µg centers in US, Canada, 250 µg 100 µg France, Poland, and Netherlands 250 µg M0 M12 M0 M12 M24 M26 VIPES OLFUS-VIPES Dose-finding Open Label Follow-Up Study 171
Slide 48: OLFUS-VIPES: Long-term Extension Data Shows Benefit Increases Over Time
OLFUS-VIPES: Long-term Extension Data Shows Benefit Increases Over Time in Phase IIb Study Response Rate at OLFUS: Cumulative Reactive Dose in OLFUS Baseline, Year-1 and Year-2 Mean ± 95% CI Observed values, ITT 100% 5,000 mg 2,453.9 mg 3,000 mg 80% 1,883.5 mg 2,000 mg 60% 1,067.8 mg Median = Median
Slide 49: OLFUS-VIPES: Immunological Changes, Ages 6-11
OLFUS-VIPES: Immunological Changes, Ages 6-11 Relative Change IgE Relative Change IgG4 R e la tiv e c h a n g e Ig E R e la tiv e C h a n g e Ig G 4 M e d ia n Median IQ ± IQ M e d ia n Median IQ ± IQ 4,000 4 ,0 0 0 1001 0 0 3,000 3 ,0 0 0 2,000 2 ,0 0 0 505 0 1,000 1 ,0 0 0 00 5005 0 0 -50-5 0
Slide 50: 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
Slide 51: CoFAR6: Efficacy And Safety – NIAID Sponsored Phase II
CoFAR6: Efficacy And Safety – NIAID Sponsored Phase II 250 mg Viaskin Peanut 221 stratified patients, 22 Enrollment centers in US, Canada, n = 75 100 mg Viaskin Peanut 250 mg Viaskin Peanut France, Poland, and Netherlands Entry OFC positive to cumulative Placebo dose of < 1044 mg peanut protein Week
Slide 52: CoFAR6: Primary Endpoint Was Met
CoFAR6: Primary Endpoint Was Met All Patients 4 – 11 Years Primary Endpoint Pre-specified Analysis • No SAEs or Epinephrine p = 0.003 p = <0.001 p = 0.005 p = <0.001 due to drug 100 100 • 96% compliance • Primary endpoint met (p 61.1% 58.8% Treatment Success (%) Treatment Success (%) 48.0% = 0.003)
Slide 53: Viaskin Milk Phase II Program: MILES
Viaskin Milk Phase II Program: MILES
Slide 54: Viaskin Milk: Milk Allergy Phase II Study Identified Safe/Effective Dose
Viaskin Milk: Milk Allergy (CMPA) Phase II Study Identified Safe/Effective Dose for Children Phase I (Part A) Phase II (Part B) Open Label Cohort at 500µg dose Placebo DSMB FDA & 150 µg Pediatric Phase I/II 300 µg*** DSMB USA & Canada Cohort at 300 µg Part A: 18 patients 300µg dose 500 µg Part B: 18
Slide 55: MILES Patient Population at Baseline
MILES Patient Population at Baseline 198 patients randomized Medical history of patients n % • 152 Children (2-11) Asthma 139 70.2 • 46 Adolescents (12-17) Atopic Dermatitis 139 70.2 CRD of Cow’s Milk Allergic Rhinitis 144 72.7 Mean Polyallergic 178 89.9 • Children: 216.3 mg Mean Cow’s Milk sIgE • A
Slide 56: MILES Results: Viaskin Milk 300µg as Potential First Treatment for CMPA
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 p = 0.042 p = 0.733 • Overall discontinuation rate of 4.5% p > 0.999 – 1.5% dropout due to AEs • Most AEs related to application sit
Slide 57: MILES Results: Significant Improvement in Threshold Reactivity
MILES Results: Significant Improvement in Threshold Reactivity with Viaskin Milk 300µg in Children 2-11 Change of CRD (ITT*†) Change of CRD (PP*) Mean (SE) Change of CRD at M12 vs Baseline, mg* Mean (SE) Change of CRD at M12 vs Baseline, mg* 1800 p = 0.985 1800 p = 0.822 p = 0.045 p = 0.043 1600 160
Slide 58: 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 (ITT*) Response Rate (PP) p = 0.522 70 p = 0.682 p = 0.027 70 p = 0.085 p = 0.649 p = 0.641 60 60 % of Responders (95% CI) % of Responders (95% CI) 50 50 40 40 30 30 55.0% 49.0% 20 20 36.7% 36.2% 36.1%
Slide 59: MILES Results: All Dose Cohorts At Month-12 CRD
MILES Results: All Dose Cohorts At Month-12 CRD, Overall Population (ITT) Mean Increase in CRD p = 0.736 Mean CRD Increase at M12 vs Baseline, mg* p = 0.008 p = 0.189 1,201.0 745.1 723.5 555.5 Median Median 400 mg 300 mg Median 100 mg Median 93 mg Placebo 150 µg 300 µg 500 µg n = 39 n = 37 n = 36 n
Slide 60: MILES Immunologic Data: sIgG4 Immunomodulation with Viaskin Milk
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 Geometric Mean (90% CI) Geometric Mean (90% CI) Geometric Mean (90% CI) p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p
Slide 61: MILES Immunologic Data: sIgE in Children 2-11
MILES Immunologic Data in Children 2-11 (ITT): Significant Immunomodulation with Viaskin Milk sIgE casein, kUA/L sIgE α-lactalbumin, kUA/L sIgE β-lactoglobulin, kUA/L Geometric Mean (90% CI) Geometric Mean (90% CI) Geometric Mean (90% CI) p = 0.018 p = 0.003 p = 0.008 p = 0.166 p = 0.336 p = 0.201 p
Slide 62: dbv
WZ dbv technologies
DBV Technologies — Investor Presentation (October 2019) on 6ix