OSE Immunotherapeutics SA · EURONEXT:OSE
OSE Immunotherapeutics SA — Investor Presentation (October 2018)
36 slides from OSE Immunotherapeutics SA's investor presentation, October 2018
Slide 1: Cancer and Autoimmune Diseases: We are armed to fight!
Cancer and Autoimmune Diseases We are armed to fight! October 2018 1
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial project
Slide 3: Company Overview: OSE's Technological Platform
OSE Immunotherapeutics Company Overview OSE’s Technological Platform: From Target Identification to Product Validation and Beyond An integrated operational immunology research platform Founded in 2012 01 Intertwined mixed team with academic research Common locations, IPO in 2015 (€ 21.1 M) Listed on
Slide 4: Investor Highlights
OSE Immunotherapeutics Investor Highlights Ongoing Phase 3 program with first results 4 programs expected to enter the clinic expected end of 2019 before the end of 2018 A potential of €1.5 B milestone payments Additional first-in-class products in in auto-immune diseases and in immuno-oncology disc
Slide 5: Our Strategy
Our Strategy Rooted in Immunology, Delivering First-in-Class Products DEVELOP PARTNER To leverage world-class clinical immunology expertise and a validated R&D platform to deliver first-in-class targets addressing unmet needs in: Our developmental pipeline has Immuno-oncology repeatedly been validat
Slide 6: First-in-Class Portfolio
First-in-Class Portfolio Immuno-Oncology and Auto-Immune Diseases Humanized Pre-Clinical PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners lead POC IMMUNO-ONCOLOGY Tedopi® NSCLC EU-US-Isr Advanced 2018 Tedopi® pancreatic Combo with PD1 OSE-172 Various cancers 2018 SIRP⍺ OSE-703 Various cancers 201
Slide 7: First-in-Class Portfolio: Tedopi
First-in-Class Portfolio Immuno-Oncology and Auto-Immune Diseases Humanized Pre-Clinical PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners lead POC IMMUNO-ONCOLOGY Tedopi® NSCLC EU-US-Isr Advanced 2018 Tedopi® pancreatic Combo with PD1 Our lead product: Tedopi® • A proprietary combination of neoep
Slide 8: Tedopi: An Alternative Approach to Cytotoxic T-Cell Activation
Tedopi® An Alternative Approach to Cytotoxic T-Cell Activation NEOEPITOPES / HLA / TCR binding: Mandatory to activate cytotoxic T-cell response Neoepitopes: Small peptides deriving from tumor specific antigens expressed in various cancers, 1st T-lymphocyte activation signal Tedopi® • A proprietary c
Slide 9: Tedopi for NSCLC after checkpoint inhibitor failure
Tedopi® For Non-Small Cell Lung Cancer (NSCLC) after checkpoint inhibitor failure LUNG CANCER: 2ND MOST COMMON CANCER 234,030 154,050 In the United States1 NEW CASES IN 2018 DEATHS IN 2018 NSCLC = 80-85% of all lung cancers 2014 2024 • Checkpoint inhibitors are rapidly becoming the first line standa
Slide 10: Tedopi in NSCLC: A Potential Breakthrough post Check-Point failure patients
10 Tedopi® in NSCLC: A Potential Breakthrough post Check-Point failure patients • Despite tremendous progress, failure is still the norm for advanced patients in NSCLC • Neoepitopes burden is a key marker for CKI efficacy • Tedopi® MOA and Phase 2 results: rationale for combination • Market potentia
Slide 11: NSCLC 2018: Despite Progress, Treatment Failure is Still the Norm
11 NSCLC 2018: Despite Progress, Treatment Failure is Still the Norm Strong Medical Need: Treatment Option Post-CKI Failure 2015 NEJM, 2015, DOI: 10.1056/NEJMoa1504627 2018 NEJM, 2018, DOI: 10.1056/NEJMoa1801005 NEJM, 2018, DOI: 10.1056/NEJMoa1801946 11
Slide 12: Resistance to PD-1/PD-L1 Checkpoint Inhibitors: Suspected Mechanisms
12 Resistance to PD-1/PD-L1 Checkpoint Inhibitors: Suspected Mechanisms HLA downregulation as one of the main reason Tedopi® 12
Slide 13: Tedopi Phase 2 results
Tedopi® Phase 2 results Increased survival in Poor Prognosis Patients Correlation between immune responses and survival CORRELATION BETWEEN EPITOPE TEDOPI® RESPONSES AND SURVIVAL (p<0.001) Low 0 - 1 epitope: 406 ± 58 days of survival Medium 2 - 3 epitopes: 778 ± 72 days of survival MEDIAN OVERALL SU
Slide 14: Tedopi Phase 2 results in advanced NSCLC
Tedopi® Phase 2 results in advanced NSCLC (stage IIIb & IV) after at least first line failure: long term survival in 64 ITT patients Surviving Patients Following 2 Year Treatment With Tedopi® 67% of the patients enrolled in the Phase 2 study were metastatic MEDIAN OVERALL SURVIVAL: 17 MONTHS 65.5% r
Slide 15: Tedopi Phase 3 Clinical Trial in Advanced NSCLC Patients
Tedopi® Phase 3 Clinical Trial in Advanced NSCLC Patients After Immune Checkpoint Inhibitor Escape Potential benefit in patients who have previously failed CKI treatment Enrolment of approximately 100 patients to be expanded to a total of 325 patients depending Invasive or metastatic on survival dat
Slide 16: Tedopi: For Pancreatic Cancer
Tedopi®: For Pancreatic Cancer 3rd MOST DEADLY CANCER 44,330 55,440 In the United States1 NEW CASES IN 2018 DEATHS IN 2018 leading to 44,330 deaths per year • Worldwide Incidence: 337,000 Cases = 330,000 Projected Number of Pancreatic Cancer Patients Cases With Mortality2 Eligible for Treatment in 2
Slide 17: Tedopi: Phase 2 Study in Pancreatic Cancer
Tedopi®: Phase 2 Study in Pancreatic Cancer The Potential to Address High Therapeutic Needs Combining Tedopi® with PD-1 Checkpoint Inhibitor Phase 2 Study To evaluate Tedopi® as a maintenance therapy, alone or in combination with CKI and evaluated versus Folfiri (current second- line SoC) Sponsored
Slide 18: First-in-Class Portfolio: OSE-172
First-in-Class Portfolio Immuno-Oncology and Auto-Immune Diseases Humanized Pre-Clinical PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners lead POC IMMUNO-ONCOLOGY OSE-172 Various cancers 2018 SIRP⍺ OSE-172 (antagonist of SIRP⍺) • First-in-class myeloid checkpoint transforming suppressive cells in
Slide 19: A Strategic Partner of Choice for OSE-172
A Strategic Partner of Choice for OSE-172 Sales > 16B€ R&D > 3B€ “The objective for the next wave of cancer immunology therapeutics is to alert the immune system (…)” Jonathon Sedgwick, VP & Global Head, Cancer Immunology Boehringer Ingelheim COMBINATION POTENTIAL GLOBAL EXECUTION CAPABILITIES INTER
Slide 20: OSE-172 Joint Development Agreement
OSE-172 Joint Development Agreement Global Immuno-oncology Partnership to develop OSE-172 €15 M upfront Upfront payment April 2018 Up to €15 M Short term payments Initiation of Phase 1 Up to €1.1 B Milestone payments + Royalties on sales Boehringer Ingelheim has acquired the rights to develop, regis
Slide 21: OSE-172: Tackles Myeloid Suppressive Cells (MDSC, TAM)
OSE-172: Tackles Myeloid Suppressive Cells (MDSC, TAM) Activates Anti-Tumor Macrophages and Dendritic Cells Function OSE-172 First-In-Class OSE IMMUNOTHERAPEUTICS DISCOVERY: SIRPα IS EXPRESSED BY MDSCS AND TAMS AND CONTROLS THEIR DIFFERENTIATION STRONG PATENT POSITION 2014-2015-2016-2017 OSE-172 inh
Slide 22: OSE-172: Inhibits Cancer Growth
OSE-172: Inhibits Cancer Growth Breast Triple Negative Model – MDSC/TAM Involvement in Breast Cancer* OSE-172 has demonstrated its impact on the Tumor Micro-Environment by switching M2 pro-tumorigenic macrophages into M1 anti-tumorigenic macrophages whilst increasing effector memory CD8 T-cells Orth
Slide 23: OSE-172: An Original Approach to CD47 Blockade in Humans
OSE-172 An Original Approach to CD47 Blockade in Humans 23
Slide 24: First-in-Class Portfolio: OSE-703
First-in-Class Portfolio Immuno-Oncology and Auto-Immune Diseases Humanized Pre-Clinical PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners lead POC IMMUNO-ONCOLOGY OSE-703 Various cancers 2019 OSE-703: Cytotoxic targeted mAb IL-7 R, in collaboration with MSKCC First-in-class product 24
Slide 25: OSE-703: Targeting the Interleukin-7 Receptor
OSE-703: Targeting the Interleukin-7 Receptor Research Collaboration with MSKCC, NY OSE-703 : cytotoxic monoclonal antibody against the alpha chain of Interleukin-7 Receptor (IL-7R) • IL-7R is aberrantly expressed on tumor cells • OSE-703 has an engineered IgG1 Fc-tail that helps to improve binding
Slide 26: OSE-703: Research Collaboration with MSKCC
OSE-703 Research Collaboration with MSKCC Strategic research collaboration: Memorial Sloan Objectives Kettering Cancer Center, New York 1. Investigate OSE-703 for solid tumors 2. Identify product’s efficacy profile and Prasad S. Adusumilli, M.D., FACS development approach • Thoracic surgeon • Expert
Slide 27: First-in-Class Portfolio: Auto-Immune Diseases
First-in-Class Portfolio Immuno-Oncology and Auto-Immune Diseases Humanized Pre-Clinical PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners lead POC AUTO-IMMUNE DISEASES FR104 Rheumatoid 2018 CD-28 arthritis OSE-127 Ulcerative Colitis 2018 IL-7 R Sjögren syndrome First-in-class product 27
Slide 28: FR104: CD28-Antagonist Immunotherapy Licensed to Janssen Biotech
FR104 CD28-Antagonist- Immunotherapy Licensed to Janssen Biotech • CD28-antagonist a key receptor on effector T lymphocytes FR-104 • Positive Phase 1 completed, Phase 2 planned for 2018 • Targeted indication: rheumatoid arthritis, partnership with Janssen Biotech €10 M upfront Up to €145 M Option ex
Slide 29: OSE-127: IL-7 Receptor Antagonist - License Option to Servier
OSE-127 IL-7 Receptor Antagonist - License Option to Servier • OSE-127: Antagonist of the Interleukin-7 α-receptor or CD127, control of pathogenic T-cells • Targeted pathologies: Ulcerative Colitis and other auto-immune diseases (Sjögren syndrome) • License option agreement with Servier in Dec. 2016
Slide 30: Current Industrial Partnerships
Current Industrial Partnerships Up to €1.5 B in Potential Milestones + Royalties FR104 OSE-127 OSE-172 €10 M upfront €10.25 M upfront €15 M upfront Option exercise fee Upfront payment August 2016 December 2016 April 2018 €30 M Up to €15 M Up to €145 M 2 step option fee Short term payments Milestone
Slide 31: Current Academic & Public Partnerships
Current Academic & Public Partnerships Financing and Innovation OSE-127 OSE-172 TEDOPI® OSE-703 EFFIMab EFFI-Clin Objective: Objective: Objective: Objective: Clinical development Clinical development Phase 2 in pancreatic cancer Product efficacy profile and until phase 2 until phase 2 in combination
Slide 32: Experienced Management Team From Discovery to Market
Experienced Management Team From Discovery to Market Dominique Costantini, M.D., Maryvonne Hiance, Vice Chairman Immunology, Chairman, & Director of Strategy • Director of Early Development, Roussel- • SangStat Atlantic, DrugAbuse Sciences HMR-Sanofi • Founder & CEO Effimune • Founder & CEO BioAllia
Slide 33: Experienced Management Team
33 Experienced Management Team From Discovery to Market Bérangère Vasseur, M.D., CMO IO Frédérique Corallo, M.D., CMO AIDs • Broad experience in oncology • Specializing in immunology development • Janssen Cilag, Roussel-HMR-Sanofi • At Roche and • Biogen, Medical Director at several biotechnology co
Slide 34: Our International Network
Our International Network Scientific Advisors and Collaborators Leslie Kean Giuseppe Giaccone Prasad Adusumilli Tom Mc Donald Katryn Wood Bert ‘t Hart Masayuki Miyasaka C.H. - Seattle NIH - Washington MSKCC – New York Queen Mary – London NDS – Oxford BPRC – Rijswijk Suita – Osaka Luis Rizzo Richard
Slide 35: OSE Immunotherapeutics – a High Potential Clinical-stage Biotech
OSE Immunotherapeutics – a High Potential Clinical-stage Biotech Key Takeaways Major immuno-oncology programs addressing unmet needs: Tedopi®: In Phase 3 (NSCLC) Entering Phase 2 (pancreatic cancer) A potential of €1.5 B milestone payments in auto-immune diseases and in immuno-oncology OSE-172: Ente
Slide 36: Contacts: A Significant Player
Contacts: A Significant Player Dominique Costantini, Chairman, Director of Early Development [email protected] Head Office +33 6 13 20 77 49 22, boulevard Bénoni Goullin 44200 Nantes, France Alexis Peyroles, CEO [email protected] Paris Office +33 6 11 51 19 77 Pépinièr
OSE Immunotherapeutics — Investor Presentation (October 2018) on 6ix