Neovacs Sa · EURONEXT:ALNEV
Neovacs Sa — Biotech Agora (May 2018)
32 slides from Neovacs Sa's conference presentation, May 16, 2018
Slide 1: Neovacs: Leader in Active Immunotherapy for Autoimmune Diseases
NEOVACS LEADER NÉOVACS IN ACTIVE Novembre 2017 IMMUNOTHERAPY FOR THE TREATMENT OF AUTOIMMUNE DISEASES FR0004032746 ALNEV 2018 CORPORATE PRESENTATION
Slide 2: Disclaimer
DISCLAIMER This presentation has been prepared exclusively by the management of Neovacs (the "Company") for the sole purpose of a presentation to Biotech Agora held on May 16, 2018 relating to the Company. Participants should read the Registration Document and the Annual Financial Report of the Comp
Slide 3: Corporate Overview: An Innovative Approach to Active Immunotherapy
CORPORATE OVERVIEW AN INNOVATIVE APPROACH TO ACTIVE IMMUNOTHERAPY Company Listed on Euronext Growth Paris since April 2010 (ALNEV, ISIN: FR0004032746) Kinoids®, anti-cytokine therapeutic vaccines. The vaccine uses the patients’ own immune system to regulate Technology inappropriate cytokine overprod
Slide 4: Kinoids: A Breakthrough Technology
KINOIDS ® : A BREAKTHROUGH TECHNOLOGY
Slide 5: A New Generation of Active Immunotherapy
A NEW GENERATION OT ACTIVE IMMUNOTHERAPY Therapeutic vaccine is active immunotherapy An antigen is injected into patient to induce or amplify a specific immune response Today Tomorrow - the Kinoids Passive Immunotherapy: Active Immunotherapy: Monoclonal Antibody Polyclonal Antibodies Kinoid tech
Slide 6: A Vaccine Approach to Treat Autoimmune Diseases
A VACCINE APPROACH TO TREAT AUTOIMMUNE DISEASES Polyclonal antibodies Targeted cytokine Kinoid to targeted cytokine Conjugation and inactivation Intramuscular Self Antibodies Injection Production Carrier protein Components of active immunotherapy Immunization+ adjuvant Stimulation of the body’s immu
Slide 7: Competitive Positioning: Polyclonal vs. Monoclonal Antibodies
COMPETITIVE POSITIONING POLYCLONAL ANTIBODIES VS. MONOCLONAL ANTIBODIES Kinoid® induces Kinoid induces binding natural polyclonal antibodies : to multiple epitopes no risk of anti-drug antibody (ADA) vs. single epitopes (Mabs) IFNα Kinoid: IFNα Kinoid: 5 injections i.m. the first year, ~ 1mg of prot
Slide 8: Kinoids: An Advanced Pipeline
KINOIDS : AN ADVANCED PIPELINE Preclinical Phase I Phase II Phase III IFNα Kinoid in Lupus - Europe, LATAM, Asia, Phase IIb ongoing U.S. IFNα Kinoid in Dermatomyositis (DM) – EU, Phase IIa US ongoing IFNα Kinoid in Type 1 Diabetes VEGF Kinoid in DMLA VEGF Kinoid in solid tumors IL-4/IL-13 Kinoid in
Slide 9: Kinoids Targeting Major Therapeutics Market
KINOIDS TARGETING MAJOR THERAPEUTICS MARKET Lupus, DM, T1D Kinoids could address many autoimmune diseases A market representing approximately Multiple sclerosis Autoimmune $45 billion in 2022(1). thyroiditis, Rheumatoid arthritis, Ankylosing spondylitis, sjögren syndrome, … (1)Estimation Researc
Slide 10: Kinoids Target Autoimmune Diseases, 3rd Cause of Morbidity
KINOIDS TARGET AUTOIMMUNE DISEASES, 3rd CAUSE OF MORBIDITY IN THE WORLD Autoimmune diseases are characterized by a dysfunction immune system leading the overproduction of an endogenous cytokine, with no reaction of the immune system 100 autoimmune diseases(1) including: type 1 diabetes, lupus, d
Slide 11: IFNα Kinoid: The Most Advanced Product from Neovacs R&D
IFNα Kinoid : The most advanced product from Neovacs Research and Development
Slide 12: Strong International IP Protection for IFNα Kinoid Until 2032
A STRONG INTERNATIONAL IP PROTECTION FOR IFNα KINOIDE UNTIL 2032 Granted Patents Patent Expiration Date (excluding SPCs) Pat.# Nature of Patent Country Exp. Date WO/2000/064937 Composition of matter EP, US 2020 WO/2004/024189 Composition of matter EP, US, CN,CA, ZA, AU, JP, BR, IN, 2023 NZ WO/2005/0
Slide 13: Why Does Neovacs Target IFNα?
WHY DOES NEOVACS TARGET IFNα? Robust scientific evidence confirms the major role of IFNα in the dysfunction of the immune system in patients with autoimmune diseases such as lupus(1), dermatomyositis(2) and type 1 diabetes(3) Lupus patients have high serum levels of IFNɑ and/or overexpress genes
Slide 14: Lupus, a Rare Disease with Multiple Symptoms
LUPUS, A RARE DISEASE WITH MULTIPLE SYMPTOMS A chronic and debilitating disease The disease affects mostly women (9 women/1 man). Lupus is characterized by periods of Celebrities suffering from lupus Selena Gomez (Singer), Seal (Singer) flares alternating with periods without symptoms (remissi
Slide 15: Current Treatments for Lupus
CURRENT TREATMENTS FOR LUPUS The current background therapy is based on: - Immunosuppressive agents: Corticosteroids, Methotrexate, azathioprine, … - Hydroxychloroquine - Monoclonal Antibody (Benlysta®) - « Pain-killers » and non steroids anti-inflammatory Available treatments aim to reduce infl
Slide 16: Clinical Program for IFNα Kinoid in Lupus: Phase I/IIa and Phase IIb
Clinical program for IFNα kinoid in lupus : phase I/IIa and phase IIb
Slide 17: Methodology and Population of Phase I/IIa Study
METHODOLOGY AND POPULATION OF PHASE I/IIa STUDY Study completed Objectives Safety Immune responses Neutralization of IFN-alpha- and SLE- dysregulated genes Population Design (Double-blind, placebo controlled, 3:1 18- 50 years (IFN-K/Placebo) SLE ACR 4/11 28 pts, 7 countries, 12 centers
Slide 18: 6 Months Results: 100% Patients Develop Anti-IFNα Antibodies
6 MONTHS RESULTS : 100% PATIENTS DEVELOP ANTI-IFNα ANTIBODIES antibodies anti-IFNa (geometric mean) antibodies anti-IFNα neutralizing - NC50 (geometric mean) IFN-K 30 µg IFN-K 240 µg IFN-K 60 µg IFN-K 120 µg Placebo Increasing doses and number of injections of IFNα Kinoid led to increased anti-IFNα
Slide 19: Polyclonal Antibody Response Neutralizes All IFNα Subtypes
6 MONTHS RESULTS : POLYCLONAL ANTIBODY RESPONSE NEUTRALIZES ALL IFNα SUBTYPES 9F3 Polyclonal antibodies Monoclonal IFNα of an IFN-K immunized Antibody Sub-type Patient (D964) anti-IFNα 10 U/mL (Dilution) (concentration A strong neutralizing capacity of anti-IFNα ng/mL) Ab induced by IFN-K administ
Slide 20: Tolerance and Anti-IFNα Antibodies Biological Activity
6 MONTHS RESULTS : TOLERANCE AND ANTI-IFNα ANTIBODIES BIOLOGICAL ACTIVITY An acceptable safety profile at the doses inducing an immune response Anti-IFNα antibodies significantly higher in lupus patients with a positive IFNα signature at baseline Anti-IFNα antibodies significantly correlated w
Slide 21: Long Term Results: Persistence of Biological Activity
LONG TERM RESULTS : PERSISTENCE OF BIOLOGICAL ACTIVITY AFTER STOPPING THE VACCINATIONS Ducreux J et al. Rheumatology 2016 Neutralizing antibodies persist up to 4 years after the first immunization Neutralizing antibodies maintain the normalization of the IFNα signature Long-term tolerance, wit
Slide 22: Methodology and Population of Clinical Phase IIb Study
METHODOLOGY AND POPULATION OF CLINICAL PHASE IIb STUDY Recruitment completed Objectives Primary end-points: Decrease of IFNα gene signature (biological criteria) and Clinical Efficacy evaluated at Month 9 Secondary end-points: SRI-4 response Lupus flares Other clinical criteria, such as “CS tap
Slide 23: A Study Approved Worldwide
A STUDY APROVED WORLDWIDE USA 100/100,000 ASIE population EUROPE 50/100,000 population prevalence 50/100,00 population prevalence prevalence AFRICA 100/100,000 population LATAM prevalence 80/100,000 population prevalence 23
Slide 24: Clinical Scores and Therapeutic Evaluation
CLINICAL SCORES AND THERAPEUTIC EVALUATION Official scores for clinical study in lupus : - BICLA et SRI-4, these 2 scores are validated by all the international health authorities, to evaluate the clinical response in clinical studies targeting lupus. - These two scores are registrable to the heal
Slide 25: Lupus Market Overview
LUPUS MARKET OVERVIEW 5-6 millions patients worldwide(1) Improving information and the quality of healthcare services promote diagnosis Benlysta® Status: registered as "add-on" treatment, indicated in adult patients (GSK) with active systemic lupus with presence of autoantibodies and high diseas
Slide 26: A Unique Positioning in Lupus Treatment
AN UNIQUE POSITIONNING IN LUPUS TREATMENT IFNα kinoid is a breakthrough therapeutic approach, which aims to meet the needs of patients, medical community and healthcare systems : - A long-term effect - A less constraining posology - Steroid-sparing: fewer long-term adverse effects - A favorable sa
Slide 27: Strategic Partnerships in U.S., Europe and China
STRATEGIC PARTNERSHIPS IN U.S., EUROPE AND CHINA TYPE PRODUCTS COMMERCIAL & OUT-LICENSING IFNα KINOID – LUPUS & DM INDUSTRIAL IFNα KINOID ACADEMIC IFNα KINOID- TYPE 1 DIABETES VEGF KINOID- OVARIAN & COLORECTAL CANCER 27
Slide 28: Recent and Upcoming Value-Creating Milestones
Recent and Upcoming Value-Creating Milestones FINAL RESULTS OF PHASE IIB STUDY WITH IFNα KINOID IN LUPUS 2018 END OF RECRUITMENT FOR THE PHASE IIB STUDY IN LUPUS WITH IFNα KINOID NEOVACS GRANTED FDA “FAST TRACK” DESIGNATION for IFNα Kinoid 2017 in lupus (SLE) NEOVACS OBTAINS IND APPROVAL FROM THE U.
Slide 29: Perspectives for 2018/2019
PERSPECTIVES FOR 2018/2019 Key milestones following positive results from the Phase IIb clinical study in lupus with IFNα kinoid : - Finalize discussions for a global partnership with the IFNα Kinoid in lupus and DM according to the usual terms for this kind of agreement. - Validate with the healt
Slide 30: Appendix
APPENDIX
Slide 31: Management Team
MANAGEMENT TEAM MIGUEL SIELER THERESE CROUGHS Directeur général Chief Medical Officer • Miguel Sieler a réalisé une carrière internationale au sein du Companye • Thérèse a rejoint Néovacs en 2015. Auparavant CMO de Cytheris, Bayer. PDG de Bayer Korea jusqu’en 1994, puis Directeur Général de directri
Slide 32: Scientific Advisory Board
Scientific Advisory Board Prof. JACQUES BANCHEREAU, PhD Prof. MIRIAM MERAD, MD, PhD Président du CSI • Professeur de sciences oncologiques et de médecine, Tisch Cancer Institute, New York, États-Unis • Directeur du département de sciences immunologiques au Jackson Laboratory for Genomics Medicine, U