Argenx Se · EURONEXT:ARGX
Argenx — Corporate Update (February 2021)
14 slides from Argenx's corporate update, Feb 1, 2021
Slide 1: Reaching Patients Through Immunology Innovation: GO Decision from ADHERE Trial in CIDP
Reaching Patients Through Immunology Innovation FEBRUARY 2021 “GO” Decision from ADHERE Trial in CIDP 1
Slide 2: Forward Looking Statements
Forward Looking Statements Safe Harbor: Certain statements contained in this presentation, other than present and historical facts and conditions independently verifiable at the date hereof, may constitute forward - looking statements. Examples of such forward - looking state - ments include those r
Slide 3: Efgartigimod: Broad Pipeline Opportunity
Efgartigimod: Broad Pipeline Opportunity 3 Landscape of IgG - medicated Severe Autoimmune Diseases (sampling) Solid Biology Rationale: Predominantly mediated by pathogenic IgGs Feasible for Biotech: Orphan indication , efficient clinical & regulatory pathway argenx Franchises & Indications Efgartigi
Slide 4: CIDP: Significant Unmet Need Exists for Patients
Rare, Chronic, and Progressive Symmetric proximal and distal weakness with sensory loss and decreased reflexes Can progress quickly to severe disability (wheelchair) 50% of patients are severely disabled at some stage of illness Pain and fatigue commonly reported Diagnosis/Metrics Commonly misdiagno
Slide 5: Solid Biology Rationale for FcRn Approach in CIDP
Solid Biology Rationale for FcRn Approach in CIDP 5 Cellular and humoral immunity components Clinical response with treatments selective for IgGs Nerve - reactive IgGs in CIDP patients Studies show pathogenic nature of patient - derived IgGs CIDP Pathophysiology Clinical Evidence Preclinical Evidenc
Slide 6: CIDP: Therapeutic Activity Shown With Increasing Selectivity For IgG Reductions
CIDP: Therapeutic Activity Shown With Increasing Selectivity For IgG Reductions Response rate active 54% vs placebo 21% after 24 weeks (N=117) S e l e c tivity for IgG R esponse R a t e Therapeutic ICE Trial 50 - 70% 80 - 100% IA with protein A matrix 33 - 80% Comparable t o P L E X IA with t r y p
Slide 7: Passive Transfer Studies Show Pathogenic Nature of Patient IgGs
7 Passive Transfer Studies Show Pathogenic Nature of Patient IgGs Ex a cerbation of EAN disease model b y injection of CIDP IgG CIDP Ig G O t h e r I gG N e r v e c o n d u c t i o n s p e e d A D Purified IgG from PLEX - responsive CIDP patients Purified IgG from CIDP patients with immunoreactivity
Slide 8: Nerve-reactive IgGs in CIDP patients
Nerve - reactive IgGs in CIDP patients 8 Anti - paranodal IgG4 ~ 10% of patients A n t i - m y e l i n sheath I g G 30 - 40% o f p a t i e n t s Myelin Sheath Node of Ranvier Autoantibodies (unknown antigens) Neuron Axon Paranodal proteins: eg. NF155, contactin - 1 Nodal proteins: eg. NF186, gliomed
Slide 9: Chronic Inflammatory Demyelinating Polyneuropathy: Phase 2/3 ADHERE Trial
• Worsening of disease within 12 weeks after drug withdrawal (INCAT, I - RODS, grip strength) • Newly diagnosed/ treatment naïve skip run - in period • Confirmation of diagnosis by independent committee 9 Treatment period Open - label Placebo - controlled Ide n t i f y patients with active CIDP Conf
Slide 10: Clear GO Based on Observed Activity in CIDP
10 Clear “GO” Based on Observed Activity in CIDP 14 responders or more: GO Less than 10 responders: NO GO Proportion of patients qualifying for Stage B Number of responders* in Stage A Threshold: Placebo Response ICE Trial (21%) NO GO : Responder rate below Threshold GO: Responder rate exceeds Confi
Slide 11: Global Immunoglobulins Market $12.8Bn and growing double digits
11 Grifols 2019, CSL 2020 28% 24% 21% 16% 6% 5% 0% 5% 10% 15% 20% 25% 30% PID CIDP Other SID ITP MG CIDP 24% CIDP represents 24% of total IVIg market by volume Global Immunoglobulins Market $12.8Bn and growing double digits
Slide 12: Key Conclusions
Key Conclusions • Efgartigimod achieved 4/4 in proof - of - concept indications; 2/2 in neuromuscular franchise • Current global IVIg sales exceeds $3B • High unmet need exists in CIDP; patients need more options 12 • GO decision to continue ADHERE enrollment in support of potential registration of
Slide 13: Uniquely Positioned for Exponential Expansion
MG ITP PV CIDP 5 th 6 th Zai collaboration Neuro Heme Skin Kidney Uniquely Positioned For exponential expansion o efgartigimod indications o therapeutic franchises o global markets ROW China Europe Japan US 13 Indications Therapeutic Franchises Global Markets
Slide 14: Reaching Patients Through Immunology Innovation
Reaching Patients Through Immunology Innovation FEBRUARY 2021 14 “GO” Decision from ADHERE Trial in CIDP