Abivax Sa · EURONEXT:ABVX
Abivax Sa — Non-Deal Roadshow (October 2019)
28 slides from Abivax Sa's roadshow presentation, Oct 28, 2019
Slide 1: Targeting the immune system to eliminate inflammatory and viral diseases as well as cancer
Targeting the immune system to eliminate inflammatory and viral diseases as well as cancer October 28, 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: ABX464: A promising candidate addressing attractive markets
ABX464: A promising candidate addressing attractive markets Total market size Coming from the proprietary Abivax library of compounds, in inflammatory biased to modulate RNA biogenesis (>2200 molecules) diseases greater than Small molecule (quinoline), administered as an oral capsule USD 70 B (once
Slide 4: ABX464 showed efficacy in DSS mouse model
ABX464 showed efficacy in DSS mouse model* ABX464 protects mice from death DSS without ABX464 leads ABX464 protects intestinal in the DSS mouse model to intestinal damage structure Relative weight (%) 120 Induction of inflammation by DSS ABX464. 20 days ABX464. 60 days 110 100 90 Days 80 0 5 10 15 2
Slide 5: ABX464 in ulcerative colitis: Background
ABX464 in ulcerative colitis: Background • Despite the availability of new drugs, there is still a high unmet medical need for patients suffering from Ulcerative Colitis and Crohn’s Disease • ABX464 Drug Candidate for UC1,2 • Is a small molecule • Administered as an oral capsule • Has potent activit
Slide 6: ABX464-101/102 study design: Phase 2a in ulcerative colitis
ABX464-101/102 study design: Phase 2a in ulcerative colitis Randomized, double-blind, placebo controlled, multi-national study followed by an open-label maintenance study Induction study (ABX464-101) Open label extension (ABX464-102) 8 weeks of induction treatment (completed) 1. year completed, 2. y
Slide 7: ABX464-101: Patient disposition
ABX464-101: Patient disposition Screened (N= 46) Randomized (N=32) ABX464 (N= 23) Placebo (N= 9) Groups were well balanced in 2 patients prematurely withdrew terms of baseline characteristics, - 1 pt due to consent withdrawal disease severity and previous use - 1 pt due to AE of biologicals 1 pt who
Slide 8: ABX464-101: Statistically significant efficacy achieved for major endpoints (day 56)
ABX464-101: Statistically significant efficacy achieved for major endpoints (day 56) Clinical remission: ABX464 Placebo p Total Mayo Score (TMS) equal or (n=20/23) (n=9/9) value lower than 2 + no sub-score >1 PP/ITT PP/ITT (PP) Clinical remission 35%/30% 11%/11% 0.16 Endoscopic improvement: Endoscop
Slide 9: ABX464-101 Partial Mayo Score Results
ABX464-101 Partial Mayo Score Results Fast onset of action and clinical responses in patients who failed on biologics Overall Patient Population Patients previously treated with biologics Change from Baseline Partial Mayo Score Change from Baseline Partial Mayo Score D0 D7 D14 D21 D28 D56 D0 D7 D14
Slide 10: Statistically significant increase in miR-124 in whole blood and rectal tissue
Statistically significant increase in miR-124 in whole blood and rectal tissue 10
Slide 11: ABX464-102 Maintenance study: Patient disposition
ABX464-102 Maintenance study: Patient disposition ABX464 Evaluable patients at Week 8 Placebo Evaluable patients at Week 8 ABX464 -101 Induction study N = 20 N=9 Full regulatory clearance in 4/6 countries: 22/23 eligible patients enrolled into the maintenance study ABX464 50mg QD N=15 ABX464 50mg QD
Slide 12: ABX464 has a good safety profile during induction and maintenance
ABX464 has a good safety profile during induction and during 12 months open label maintenance • Safety profile consistent with previous clinical studies ( >180 patients treated with ABX464) • No deaths, no malignancies, no severe infections, no significant changes in the laboratory parameters includ
Slide 13: Clinical Remission after Induction (8 weeks) and Maintenance (52 weeks)
Clinical Remission after Induction (8 weeks) and Maintenance (52 weeks) Evaluable Patients / N=19 Double Blind ABX464 50mg versus Placebo (centrally randomised) N=13 N=6 Induction Clinical Remission No Clinical Remission 8 weeks N=6 N=7 52 weeks ABX464 open label oral 50mg qd N=6 N=7 Maintenance CR
Slide 14: Clinical Remission after Induction (8 weeks) and Maintenance (52 weeks)
Clinical Remission after Induction (8 weeks) and Maintenance (52 weeks) Evaluable Patients / N=19 Double Blind ABX464 50mg versus Placebo (centrally randomised ) N=13 N=6 Induction Clinical Remission No Clinical Remission 8 weeks N=1 N=5 52 weeks ABX464 open label oral 50mg qd N=1 N=5 Maintenance No
Slide 15: Clinical Remission after induction (8 weeks) and Maintenance (52 weeks)
Clinical Remission after induction (8 weeks) and Maintenance (52 weeks) Evaluable Patients / N=19 Double Blind ABX464 50mg versus Placebo (centrally randomised ) N=13 N=6 Induction Clinical Remission No Clinical Remission Clinical Remission No Clinical Remission 8 weeks N=6 N=7 N=1 N=5 52 weeks ABX4
Slide 16: Changes of Partial Mayo Score and Fecal Calprotectin during maintenance
Changes of Partial Mayo Score and Fecal Calprotectin during the maintenance phase Partial Mayo Score - Mean Fecal Calprotectin µg/g - Median 4.00 350.00 3.50 300.00 3.00 250.00 2.50 200.00 All patients (N=19) 2.00 150.00 1.50 Patients previously 100.00 treated with biologics ( 1.00 N=7) 50.00 0.50 1
Slide 17: ABX464-102: Efficacy data at 52 weeks open label extension
ABX464-102: Efficacy data at 52 weeks open label extension ABX464 50mg ABX464 n=22 Observed Cases FAS with LOCF Clinical Remission 75 % (N=16) 55% (12/22) Endoscopic Improvement 100% (N=16) 72% (16/22) Total Mayo Score Reduction from maintenance baseline - 57% (N=16) - 52% (N=22) Partial Mayo score
Slide 18: Conclusions
Conclusions: ABX464 oral 50mg QD drug candidate for moderate to severe UC patients • Good safety and tolerability of chronic treatment with ABX464 50mg QD in patients with UC Conclusion is further supported by safety analysis in more than 180 Healthy Volunteers and HIV infected Patients (No Serious
Slide 19: ABX464 ongoing and planned studies
ABX464 ongoing and planned studies • Phase 2b study in 232 patients with moderate to severe ulcerative colitis is currently ongoing in Canada and Europe • Phase 2a studies ongoing in Rheumatoid Arthritis and planned in Crohn’s disease • Preclinical models running in several inflammatory diseases, in
Slide 20: ABX464 novel mechanism of action
ABX464 novel mechanism of action: Generation of miR-124 leads to reduction of pro-inflammatory cytokines Established miR-124 targets: (translation ) Outcome ABX 1 CBC 464 MCP-1/ MCP-1/CCL2 CCL2 IL-6 STAT 3 TNF-α miR-124 JAK pathway IL-6 IL-6R blocked TNF-α miR-124 TACE TNF-α (TNF-α converting enzyme
Slide 21: ABX196 – An iNKT agonist for the treatment of liver cancer
ABX196 – An iNKT agonist for the treatment of liver cancer Mechanism of Action Synthetic glycolipid agonist of iNKT (invariant Natural Killer T) cells in liposomal formulation Licensed from Scripps Research, University of Chicago, Brigham-Young University © 2015 American Association for Cancer Resea
Slide 22: ABX196 controls tumor growth in orthotopic HCC mouse model and increases survival
ABX196 controls tumor growth in orthotopic HCC mouse model... And increases survival Macroscopic Liver tumor invasion evaluation on day 61 or at death of the animals Tumor Invasion (% of liver) Percent survival p value p value p value < 0,01 < 0,001 100 ABX196 + Anti-PD-1** < 0,01 ABX196* 100 80 Ant
Slide 23: Abivax: A strong and diversified pipeline
Abivax: A strong and diversified pipeline Lead generation Research Preclinical Phase 1 Phase 2 Phase 3 ABX464 Phase 2b on going Ulcerative colitis Inflammatory diseases ABX464 Phase 2a FPI: Q4, 2019 / Q1 2020 Crohn’s disease x ABX464 Phase 2a on going Rheumatoid arthritis HIV ABX464 Phase 2b, subjec
Slide 24: Key company facts
Key company facts Milestones Shareholder structure1 Founded in 2013 Focus on Truffle Capital by Truffle Capital 34% inflammatory Sofinnova 46% diseases with Board & management Abivax went ABX464 in Sept. public in June 2015, 2% Incubator & founders 2018 raising €57.7m 5% 13% Public Location Operatio
Slide 25: H1 2019: Key financial figures
H1 2019: Key financial figures 25
Slide 26: Highly experienced Executive Committee
Highly experienced Executive Committee • Prof. Hartmut Ehrlich, M.D. • Chief Executive Officer Former Head of Global R&D, Baxter BioScience • Didier Blondel • Pierre Courteille • Jérôme Denis • Alexandra Pearce • Chief Financial Officer & Pharmacist, MBA Ph.D. Ph.D. Board Secretary • Chief Commercia
Slide 27: Interview of Prof. Sandborn – UEG Week 2019
Interview of Prof. Sandborn – UEG Week 2019 Prof. William Sandborn, M.D. University of California San Diego School of Medicine, USA Dr. William Sandborn is a board-certified gastroenterologist and one of the world‘s top experts in the management of Crohn’s disease and ulcerative colitis. Dr. Sandbor
Slide 28: Interview of Prof. Sandborn – UEG Week 2019
Interview of Prof. Sandborn – UEG Week 2019