Roche Holding Ltd · SIX:RO
Roche — Conference Presentation (2016)
25 slides from Roche's conference presentation, Sep 11, 2016
Slide 1: Roche: At the Forefront of R&D Innovation and Breakthrough Treatments
Roche: At the Forefront of R&D Innovation and Breakthrough Treatments Michael Varney, Ph.D. Executive Vice President, Genentech Research and Early Development (gRED) Member of Corporate Executive Committee (CEC)
Slide 2: Forward-looking statements
This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, str
Slide 3: Executive Summary
Executive Summary • Roche Group has an industry leading portfolio: – Large and Diverse • Oncology: Continue to innovate, dominate and expand – Cancer Immunotherapy: extensive and combination approach – Breast cancer: SERD GDC-0810 • Beyond oncology: Follow the science – Neuroscience: Nav1.7 – Infect
Slide 4: Deep Biological Insights Drive Disease Strategies
Deep Biological Insights Drive Disease Strategies Oncology • Expand dominant leadership • Explore new MOA: Cancer immunotherapy, SERD, etc. • Pursue combinations and personalized medicines • Develop new delivery platforms: ADC, Bi-specific, etc. Immunology Neuroscience • Grow respiratory and RA • Fo
Slide 5: 2016 Onwards: Significant Launch Activities
2016 Onwards: Significant Launch Activities Venetoclax R/R CLL including 17p del Cotellic + Zelboraf Emicizumab (ACE910) NMEs BRAFmut melanoma Hemophilia A Alecensa Lebrikizumab 2L ALK+ lung cancer Severe Asthma Atezolizumab Ocrelizumab Lampalizumab 2L+ lung and bladder cancer RMS/ PPMS Geographic a
Slide 6: Roche Has the Most Breakthrough Designations
Roche Has the Most Breakthrough Designations Breakthrough Therapy 12 Designations Year Molecule Ocrelizumab (PPMS) 2016 Venetoclax (AML) Rank Company # Venetoclax + Rituxan (R/R CLL) Actemra (Systemic sclerosis) 1 Roche 12 Atezolizumab (NSCLC) 2 BMS 8 2015 Venetoclax (R/R CLL 17p del) Emicizumab/ACE
Slide 7: Executive Summary
Executive Summary • Roche Group has an industry leading portfolio: – Large and Diverse • Oncology: Continue to innovate, dominate and expand – Cancer Immunotherapy: extensive and combination approach – Breast cancer: SERD GDC-0810 • Beyond oncology: Follow the science – Neuroscience: Nav1.7 – Infect
Slide 8: CI Strategy: Combinations are the Future
CI Strategy: Combinations are the Future aCEA-IL2v FP Immunotherapy portfolio aCSF-1R aFAP-IL2v FP chemo Launched/ aCD40 late-stage portfolio aOX40 IDO atezolizumab aCEA/CD3 TCB aCD20/CD3 TCB Targeted combinations approved venetoclax Chemotherapy combinations approved Roche combinations in trials Ch
Slide 9: Cancer Immunology Research Focus: The Next Generation
Cancer Immunology Research Focus: The Next Generation T T T DC DC MS TR T T T Cancer cell death and Initiation of T cell activation Immune cell Immune release of cancer Immune and expansion trafficking and suppression proteins Response infiltration Costimulators: Stromal Inhibitory checkpoints: modi
Slide 10: anti-OX40: Dual Action Promotes T cell Activation and T Regulatory Cell Inhibition
anti-OX40: Dual Action Promotes T cell Activation and T Regulatory Cell Inhibition OX40 engagement Antigen Presenting on Treg cells Cell OX40L OX40L TCR OX40 OX40 OX40 IFN-g Treg Suppressive T cell Effector T cell Reverse inhibition of proliferation, survival, effector function Adapted from Nature R
Slide 11: anti-OX40: Promising Anti-Tumor Activity as Single Agent and in Combination
anti-OX40: Promising Anti-Tumor Activity as Single Agent and in Combination with anti-PD-L1 2500 2500 anti-PD-L1 anti-PD-L1 3) 3 ) 3) ) anti-OX40 2500 3) 3 ) anti-OX40 3 control (mm (mm control (mm control control anti-OX40++anti-PD-L1 anti-PD-L1 volume (mm anti-OX40 volume (mm 2000 2000 volume (mm
Slide 12: GDC-0919 is a Potent and Selective IDO1 Inhibitor
GDC-0919 is a Potent and Selective IDO1 Inhibitor Source of IDO IDO1: Dendritic Cell Tumor Macrophage • IDO1 activity contributes to maternal- fetal tolerance and tumor immune escape Mechanism of Action • Expression correlates with poor patient survival across a range of tumors • MOA: Catabolizes Tr
Slide 13: Expanding our Leadership in Breast Cancer
Expanding our Leadership in Breast Cancer SERDs degrade ER, down-regulate Estrogen Receptor (ER) and antagonize ER transcriptional activity atezolizumab Others (MPDL3280A) 1% Ipatasertib TNBC (GDC-0068) 13% HER2+ 21% ER+ SERD 65% (GDC-0810; GDC-0927) Taselisib PI3K Inhibitor (GDC-0032) 13
Slide 14: SERD GDC-0810 Anti-tumor Activity in Patient with Mutant ESR1
SERD GDC-0810 Anti-tumor Activity in Patient with Mutant ESR1(E380Q) Pre-treatment at Screening On-treatment at Cycle 2 Day 3 FES-PET Abnormal uptake in bone Resolved uptake in bone Pre-treatment at Screening Post-treatment at Cycle 6 Day 23 45% reduction in target lesions CT 14
Slide 15: Executive Summary
Executive Summary • Roche Group has an industry leading portfolio: _– Large and Diverse • Oncology: Continue to innovate, dominate and expand _ – Cancer Immunotherapy: extensive and combination approach _ – Breast cancer: SERD GDC-0810 • Beyond oncology: Follow the science – Neuroscience: Nav1.7 – I
Slide 16: Beyond Oncology: Robust Portfolio across Multiple TAs
Beyond Oncology: Robust Portfolio across Multiple TAs Phase 1 Phase 2 Phase 3 Marketed Cadherin-11 Mab RA lebrikizumab - COPD MabThera pemphigus vulgaris Actemra – RA Actemra – Polyarticular & Systemic Juvenile Cat-S antag - Autoimmune Diseases lebrikizumab - Atopic Dermatitis Actemra giant cell art
Slide 17: Pain Remains a Huge Unmet Need
Pain Remains a Huge Unmet Need Medical Issue Unmet Need Opportunity • 20% of individuals experience • Only 25% of patients achieve • Pain drugs with new pain (majority moderate- adequate relief with current MOAs that: severe) therapy − Increase potency • Current development • Inadequate response pri
Slide 18: Nav1.7 Genetically Validated in Humans
Nav1.7 Genetically Validated in Humans Peripheral pain sensing - Central + - receptors Nervous + + System Peripheral nerve C-fiber 1. Human Nav1.7 mutations • Loss of function mutations results in pain insensitivity (CIP - congenital insensitivity to pain) • Activating mutations cause spontaneous pa
Slide 19: gRED has Potent and Selective Nav 1.7 Antagonists
gRED has Potent and Selective Nav 1.7 Antagonists Selectivity profile of GDC-0276 GDC-0276 inhibits pain in an (>25-fold selective over other Nav channels) IEM [Nav1.7(I848T)] transgenic mouse Paw activity Time (Min) Clinical Program Summary • GDC-0276: SAD complete and MAD to be completed this year
Slide 20: Severe Influenza – Significant Unmet Need
Severe Influenza – Significant Unmet Need • 600,000 hospitalizations in US and EU • 25,000 deaths in US alone • Vaccinations: Efficacy dependent on immunocompetence and antigen match Epidemiology 2014: CDC estimate of vaccine effectiveness only 18% against circulating H3N2 • Cases: 80% Influenza A
Slide 21: Novel Influenza-A Antibody Can Rescue Lethal Infection
Novel Influenza-A Antibody Can Rescue Lethal Infection Dose Response in lethal mouse model Hemagglutinin Anti-FluA Synergy with Tamiflu in lethal mouse model Anti-Flu A • Human antibody binds to a conserved site on the stalk of HA, blocking endosomal fusion required for viral Combination* replicatio
Slide 22: Anti-Flu A Reduces Viral Load and Symptoms in Humans
Anti-Flu A Reduces Viral Load and Symptoms in Humans Global Phase 2b ‘Proof of Concept’ study in hospitalized influenza A infected patients began Q1 2015 Median AUC by quantitative PCR -97.5% p=0.0051 Viral Load Composite Symptom Score Placebo 3600mg Symptom Score 207.7 37.7 % Reduction 81.8% p-Valu
Slide 23: gRED: Continuing the transformative innovation into the future
gRED: Continuing the transformative innovation into the future • Innovation is alive and well at gRED: top talent and great portfolio • Continue to focus on oncology while expanding into boarder therapeutic areas by following the science • gRED is a premier innovation center for Roche with access to
Slide 24: gRED Continues the Tradition of Innovation
gRED Continues the Tradition of Innovation Early Dev Phase 1 Phase 2 Phase 3 Registration Marketed NME Anti-CD20/CD3 SERD (GDC-0810) Taselisib Atezolizumab Avastin NME ChK-1 inh (GDC-0575) Anti-Influenza A Ipatasertib Venetoclax Rituxan/ (GDC-0068) MabThera NME ERK inh (GDC-0994) Ocrelizumab Polatuz
Slide 25: Doing now what patients need next
Doing now what patients need next