Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (January 2019)
33 slides from Abivax Sa's investor presentation, January 2019
Slide 1: Abivax Corporate Presentation
TARGETING THE IMMUNE SYSTEM TO ELIMINATE INFLAMMATORY AND VIRAL DISEASE ABIVAX CORPORATE PRESENTATION January 2019
Slide 2: Forward looking statements
Forward looking statements This presentation contains information pertaining to Abivax S.A. (“Abivax”). Neither Abivax, nor its management, shareholders, directors, advisors, employees or representatives make any representation or warranty, express or implied, as to the fairness, the accuracy, compl
Slide 3: Abivax core management team
Abivax core management team Today’s presenters Prof. Hartmut Ehrlich, M.D. Chief Executive Officer Didier Blondel Chief Financial Officer & Board Secretary Ex-Head of Global R&D, Jean-Marc Steens Baxter BioScience M.D VP & Chief Medical Officer 3
Slide 4: Abivax has three key core pillars of value
Abivax has three key core pillars of value ABX464 ABX196 Targets CBC 80/20 complex, thereby Targets and activates invariant inducing enhanced RNA splicing natural killer T immune cells 1 Ulcerative Colitis 2 HIV 3 Hepatocellular Carcinoma What: • Upregulation of miRNA124 resulting in • Long-lasting
Slide 5: Anti-Inflammatory properties of ABX464
Anti-Inflammatory properties of ABX464 An oral drug with Novel Mechanism of Action Invention ABX464 Preclinical validation in Ulcerative Colitis (UC) mouse model • July 2017: Nature scientific reports publication of compelling • 2015: Recognition of ABX464 having strong anti-inflammatory anti-inflam
Slide 6: Phase 2a Study Design (ABX464-101)
Phase 2a Study Design (ABX464-101) Randomized, double-blind, placebo controlled, multi-national study Induction Study (ABX464-101) – 8 weeks of treatment Maintenance Study (ABX464-102) – 52 weeks (On-going) ABX464 – Single Dose 50mg o.d. Randomisation ABX464 – Single Dose 50mg o.d. 2:1 Matching Plac
Slide 7: Patient demographics and baseline disease characteristics
Patient demographics and baseline disease characteristics Groups generally well-balanced; comparable with competition ABX-464 Placebo Total N = 23 N=9 N = 32 Age (years) Mean (Min-Max) 42.96 (20.0 – 73.0) 44.11 (20.0 – 64.0) 43.28 (20.0 -73.0) Sex Male 12 (52.2%) 8 (88.9%) 20 (62.5%) BMI (kg/m2) at
Slide 8: Strong efficacy signal observed
Strong efficacy signal observed • Clinical Remission rate 35.0 % of ABX464 patients in Clinical Remission (Placebo = 11.1%) defined as Total Mayo Score being less than or equal to two, with no individual sub-score greater than one. 35.0 % of ABX464 patients in Clinical Remission (Placebo = 11.1%
Slide 9: Mucosal healing in an ABX464 treated patient
Mucosal healing in an ABX464 treated patient Courtesy of Prof. Severine Vermeire Before ABX464 After ABX464 9
Slide 10: Mayo Score Results
Mayo Score Results Statistically significant signal observed in TMS and PMS ABX464: Fast onset of action and clinical responses in patients who failed on biologics 10
Slide 11: Calprotectin level
Calprotectin level Trend of greater reduction despite high placebo response - Consistent with TMS results % of patients with at least a 50% reduction from Baseline in Fecal Calprotectin ABX464 (n=20) 75.0% Placebo (n=8) 50.0% 11
Slide 12: Statistically significant increase in miR-124 expression
Statistically significant increase in miR-124 expression Total blood and Rectal tissue miR-124 Expression in Total Blood miR-124 expression in Rectal Biopsies 900 853.2 ± 2.0 * 729.5 ± 2.4 * 10 800 9 * 7,69 700 8 Fold induction (Ratio) Fold Induction (ratio) 600 7 6 500 Treated 5 400 Placebo 4 300 3
Slide 13: Efficacy signal confirmed by histopathology (Geboes Score)
Efficacy signal confirmed by histopathology (Geboes Score) • Independent, blinded histopathologist assessed rectal and sigmoidal biopsies according to Total Geboes Score, chronic inflammatory sub-score and acute inflammatory sub-score (most specific criteria for induction phase: Neutrophils in the e
Slide 14: Trend to greater improvement in Mental Health Component of SF-36
Trend to greater improvement in Mental Health Component of SF-36 Questionnaire • SF-36 = Norm-based Scale (a 50-Score represents the norm [US population]) • ABX464 leads to a important improvement in MCS (8.04 points) in markedly impaired population 14
Slide 15: Safety Profile
Safety Profile Good safety profile – Consistent with previous studies Patients experiencing at least one TEAEs (Treatment Emergent Adverse Events) by ABX-464 Placebo SOC and PT (>5%) regardless of causality (N=23) (N=9) N (%) N (%) Any Treatment-Emergent Adverse Events 18 (78.3%) 5 (55.6%) Gastroint
Slide 16: ABX464 in Inflammatory Diseases: Executive Summary
ABX464 in Inflammatory Diseases: Executive Summary • ABX464 is a small molecule from ABIVAX’s proprietary RNA biogenesis platform with a novel mode of action through its binding to a nuclear cellular protein complex (Cap Binding Complex) involved in the biogenesis of RNAs. • Binding of ABX464/N-Glu
Slide 17: Phase 2a results support continuation of ABX464 in UC
Phase 2a results support continuation of ABX464 in UC as well as clinical exploration in other inflammatory indications • Clinical results warrant the conduct of Phase 2b Study – ABX464-103 study - • Patients with moderate to severe Ulcerative Colitis refractory to conventional and/or biological the
Slide 18: ABX464 Mechanism of Action
ABX464 Mechanism of Action Molecular target : CBC 80/20 Conformational change of CBC complex Activity : enhanced RNA splicing Hypotheses being investigated : Biological 1. Enhanced splicing of a long, non- 1. Generation of neoantigens and initiation of codingRNA, leading to miR124 Enhanced viral RNA
Slide 19: Binding of ABX464 to CBC induces a conformational change
Binding of ABX464 to its target CBC induces a conformational change and leads to enhanced RNA splicing Images of higher resolution have been produced for CBC Cryo-EM of the CBC and the ABX464-CBC complex structure alone and CBC-464 and are currently being analyzed 19
Slide 20: Abivax has three key core pillars of value
Abivax has three key core pillars of value ABX464 ABX196 Targets CBC 80/20 complex, thereby Targets and activates invariant inducing enhanced RNA splicing natural killer T immune cells 1 Ulcerative Colitis 2 HIV 3 Hepatocellular Carcinoma What: • Upregulation of miRNA124 resulting in • Long-lasting
Slide 21: ABX196 shows anti-cancer effects in mouse models
ABX196 shows anti-cancer effects in mouse models Liver cancer is a devastating disease with rapid mortality ABX196 shows to be a potent immune response activator • Reduces tumor progression in Hepatocellular Carcinoma (HCC) and B16 melanoma models 2017 HCC 2017 HCC new 2017 HCC Region prevalence1 an
Slide 22: High unmet medical need in HCC
High unmet medical need in HCC: Response Rates with Nivolumab (Checkmate 040 Study) Uninfected Untreated/ Uninfected Sorafenib HCV HBV All Intolerant Progressors (N=50) (N=51) (N=214) (N=56) (N=57) ORR 21% 20% 20% 14% 20% Med DOR 8.4 mo NR 9.9 mo NR 9.9 mo ORR: Objective Response Rate; DOR: Duration
Slide 23: Abivax: A strong and diversified pipeline
Abivax: A strong and diversified pipeline Lead generation Research Preclinical Phase 1 Phase 2 Phase 3 HIV ABX464 Phase 2b to start H1, 2019 Lasting viral remission Ulcerative Colitis ABX464 Phase 2b to start Q1, 2019 Crohn’s Disease ABX464 Phase 2a to start Q1, 2019 Rheumatoid Arthritis ABX464 Phas
Slide 24: Key company facts
Key company facts Overview Shareholder structure3 (undiluted) Founded in 2013 by Truffle Capital Truffle Public Capital Abivax went public in June 2015, 45% 47% raising EUR 57.7m Primary listing: Euronext (Paris) Incubator / Board & ABVX : FR0012333284 Founders Management Liquidity: 30K shares/day i
Slide 25: Highly experienced Executive Committee
Highly experienced Executive Committee Prof. Hartmut Ex-Head of Global R&D, Baxter BioScience Ehrlich, M.D. Chief Executive Officer Didier Blondel Pierre Courteille Jérôme Denis, Alexandra Pearce Chief Financial Pharmacist, MBA Ph.D. Ph.D. Officer & Board Chief Commercial VP, Process Dev. VP, Regula
Slide 26: ABX464 in HIV - Back-up slides
Back-up slides ABX464 in HIV 26
Slide 27: ABX464: a functional cure for HIV
ABX464: a functional cure for HIV Standard ART1 suppresses HIV as long as patients are ABX464 aims to be a functional cure for HIV by reducing compliant with treatment the viral reservoir HIV Virus Standard Untreated 1 Suppressed Treatment Current Results Target + ABX464 Viral recurrence 1 2 loop 2
Slide 28: ABX464-005 Study design: assessing different dosing regimens
ABX464-005 Study design: assessing different dosing regimens Open-label study Inclusion criteria: HIV infected patients on suppressive triple 23 patients therapy (standard of care) 1 2 Cohort A Primary endpoint: Cohort B • Safety and pharmacokinetics 11 patients Secondary endpoints: 12 patients • HI
Slide 29: ABX464-005 Treatment-emergent Adverse Drug Reactions
ABX464-005 :Treatment-emergent Adverse Drug Reactions* GRADE 1 GRADE 2 150mg (n=11) 50mg (n=13) 150mg (n=11) 50mg (n=13) Any Treatment Emergeant AE (Related) Number of patients (%) experiencing at least one TEAE 7 (63.6) 5 (38.5) 2 (18.2) 1 (7.7) Gastrointestinal Disorders Abdominal pain 2 (18.2) 1
Slide 30: ABX464-005 Results: Summary
ABX464-005 Results: Summary Open-label study Inclusion criteria: HIV infected patients on suppressive triple 23 patients therapy (standard of care) 1 2 Cohort A: 150mg Responders based on: Cohort B: 50mg HIV DNA in blood (HIV DNA copies/106 cells) 11 patients 12 patients Responders (8) Non-responder
Slide 31: ABX464-005 both cohorts: dose dependent miR124 increase
ABX464-005 both cohorts: dose dependent miR124 increase Cohort A (150mg daily, 28 days) Cohort B (50mg daily, 84 days) Treatment Treatment Fold Induction of miRNA 124 expression1 Fold Induction of miRNA 124 expression1 compared to baseline compared to baseline Dose-dependent increase in miRNA 124 ex
Slide 32: Next steps: phase 2b study in Europe
Next steps: phase 2b study in Europe 1 • Stratify HIV patients on baseline HIV viral reservoir (high vs low) Stratify HIV patient • Create two subgroups: a high and low baseline HIV viral reservoir arm (baseline < 200 DNA copies population + / million CD4 cells) 2 • Demonstrate ABX464 efficacy by co
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