Abivax Sa · EURONEXT:ABVX
Abivax Sa — Corporate Update (October 2018)
29 slides from Abivax Sa's corporate update, October 2018
Slide 1: Top-line results of the phase IIa study with ABX464 in ulcerative colitis
TARGETING THE IMMUNE SYSTEM TO ELIMINATE VIRAL AND INFLAMMATORY DISEASE Top-line results of the phase IIa study with ABX464 in ulcerative colitis October 2018
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, M.D. Baxter BioScience 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 IIa Study Design (ABX464-101)
Phase IIa 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 Pla
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: Topline Results: Phase IIa (ABX464-101) in Ulcerative Colitis
Topline Results : Phase IIa (ABX464-101) in Ulcerative Colitis Strong Efficacy signal observed • Clinical Remission rate (i.e. Primary endpoint for registration) ▪ 35.0 % of ABX464 patients in Clinical Remission (Placebo = 11.1%) • Mucosal Healing rate ▪ 50.0 %* of ABX464 patients with Mucosal Heali
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 Fast onset of action – Greater difference over Placebo observed in Biologics refractory Patients 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: 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 13: Conclusions
Conclusions • Results show statistically significant efficacy based on both clinical and endoscopic endpoints • Rapid onset of efficacy with 3.2-fold improvement in clinical remission rate and 4.5-fold in mucosal healing • ABX464 was safe and well tolerated • Convenient once a day oral regimen for c
Slide 14: Phase IIa results support continuation of ABX464 in UC and other indications
Phase IIa results support continuation of ABX464 in UC as well as clinical exploration in other inflammatory indications • Full study results (incl. Geboes score, miRNA, Microbiome, QoL) expected by October • Study results Communication (ECCO, DDW, ACG,…) and Publication planned • Clinical results w
Slide 15: 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 16: Cryo-EM of the ABX464-CBC complex structure
Cryo-EM of the ABX464-CBC complex structure Images of higher resolution have been produced for CBC alone and CBC-464 and are currently being analyzed 16
Slide 17: 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 18: 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 19: 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 20: 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 21: 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 22: 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 23: Next steps: phase IIb study in Europe
Next steps: phase IIb 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 c
Slide 24: 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 25: 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 26: 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 27: 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 28: Key company facts
Key company facts Overview Shareholder structure2 (undiluted) Founded in 2013 by Truffle Capital Truffle Public Capital Abivax went public in June 2015, 47% 48% raising EUR 57.7m Primary listing: Euronext (Paris) Incubator Holding ABVX : FR0012333284 / Founders… 3% Management Liquidity: 30K shares/d
Slide 29: 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