Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (December 2019)
22 slides from Abivax Sa's investor presentation, December 2019
Slide 1: Mobilizing the immune system to fight inflammatory and viral diseases, as well as cancer
Mobilizing the immune system to fight inflammatory and viral diseases, as well as cancer December, 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: Key company facts
Key company facts Milestones Shareholder structure1 and market cap2 Focus on inflammatory Founded in 2013 diseases with ABX464 Truffle Capital by Truffle Capital in Sept. 2018 34% Sofinnova €234 m 46% Board & management Abivax went 2% Incubator & founders public in June 2015, raising EUR 57.7m 5% 13
Slide 4: 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 ABX464 Phase 2a on going Rheumatoid arthritis HIV ABX464 Phase 2b, subject
Slide 5: ABX464: A promising candidate addressing attractive markets
ABX464: A promising candidate addressing attractive markets Coming from the proprietary Abivax library of compounds, Total market size biased to modulate RNA biogenesis (>2200 molecules); in inflammatory Strong collaboration with EVOTEC diseases greater than Small molecule (quinoline), administered
Slide 6: 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 7: 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) First year completed,
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: Mucosal healing in an ABX464 treated patient
Mucosal healing in an ABX464 treated patient Courtesy of Prof. Severine Vermeire Before ABX464 After ABX464 Mobilizing the immune system to fight inflammatory and viral diseases, as well as cancer 9
Slide 10: ABX464-101 Partial Mayo Score Results
ABX464-101 Partial Mayo Score Results Fast onset of action and clear responses in patients who failed on biologics 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 S
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: Clinical Remission after induction (8 weeks) and Maintenance (52 weeks)
Clinical Remission after induction (8 weeks) and Maintenance (52 weeks) Double Blind ABX464 50mg versus Placebo (centrally randomised) Evaluable Patients /N=19 N=13 N=6 Induction Clinical Remission No Clinical Remission 8 weeks N=5 N=8 52 weeks ABX464 open label oral 50mg qd N=5 N=8 Maintenance CR :
Slide 13: Clinical Remission after induction (8 weeks) and Maintenance (52 weeks)
Clinical Remission after induction (8 weeks) and Maintenance (52 weeks) Double Blind ABX464 50mg versus Placebo ( centrally randomised) Evaluable Patients /N=19 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 14: Clinical Remission after induction (8 weeks) and Maintenance (52 weeks)
Clinical Remission after induction (8 weeks) and Maintenance (52 weeks) Double Blind ABX464 50mg versus Placebo ( centrally randomised) Evaluable Patients /N=19 N=13 N=6 Induction Clinical Remission No Clinical Remission Clinical Remission No Clinical Remission 8 weeks N=5 N=8 N=1 N=5 52 weeks ABX46
Slide 15: Changes of Partial Mayo Score and fecal calprotectin during maintenance phase
Changes of Partial Mayo Score and fecal calprotectin during the maintenance phase for all patients and patients refractory to biologics Partial Mayo Score – Mean Fecal calprotectin µg/g – median 4.0 350 300 3.0 250 200 2.0 150 100 1.0 50 0.0 0 Day 0 (OLE) M3 M6 M9 M12 Day 0 (OLE) M3 M6 M9 M12 All pa
Slide 16: ABX464-102: Efficacy data at 52 weeks open label extension
ABX464-102: Efficacy data at 52 weeks open label extension ABX464 50 mg, PP ABX464 50 mg, ITT 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 reduction from ma
Slide 17: ABX464 showed a good safety profile during induction and 12 months maintenance
ABX464 showed a good safety profile during induction and 12 months open label maintenance phase Safety profile consistent Overall: No deaths, no malignancies, no severe infections, no significant with previous and ongoing changes in the laboratory parameters including blood cell counts clinical stud
Slide 18: Conclusions
Conclusions Good safety and tolerability of chronic treatment with ABX464 50mg QD in patients with UC ABX464 oral 50mg QD Conclusion is further supported by safety analysis in drug candidate for moderate more than 180 healthy volunteers and HIV infected patients (no serious adverse reactions, no sev
Slide 19: ABX464 ongoing and planned studies
ABX464 ongoing and planned studies Phase 2b in ulcerative colitis: • Conducted with IQVIA as CRO • 232 patients, 18+ countries, 150+ study sites Phase 2b study in 232 patients with moderate to severe • 4 study arms (placebo, 25, 50, 100 mg QD) ulcerative colitis is currently ongoing in Canada and Eu
Slide 20: ABX464 novel mechanism of action: Generation of miR-124 reduces pro-inflammatory cytokines
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: Interview of Prof. Sandborn – UEG Week 2019
Interview of Prof. Sandborn – UEG Week 2019 Mobilizing the immune system to fight inflammatory and viral diseases, as well as cancer 21
Slide 22: 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