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IO Landscape Analysis - JPM18 - Aiman Shalabi

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As delivered to the Endpoints News breakfast at JPM18 on January 9, 2018

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IO Landscape Analysis - JPM18 - Aiman Shalabi

  1. 1. IO LANDSCAPE ANALYSIS JPM18 JANUARY 9, 2018 AIMAN SHALABI PHARMD, MBA CHIEF MEDICAL OFFICER CLINICAL ACCELERATOR PHILANTHROPIC VENTURE FUND CANCER RESEARCH INSTITUTE
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  3. 3. 26 IMMUNO-ONCOLOGY AGENTS APPROVED GLOBALLY Therapy type Therapy name Company Target T-cell targeted immunomodulator (6 in total) Ipilimumab Bristol-Myers Squibb Co CTLA-4 Nivolumab Bristol-Myers Squibb Co PD-1 Pembrolizumab Merck & Co Inc PD-1 Atezolizumab Roche/Genentech Ltd PD-L1 Avelumab Merck KGaA PD-L1 Durvalumab AstraZeneca/MedImmune LLC PD-L1 Other immunomodulator (8 in total) Aldesleukin Novartis AG IL2R Imiquimod Valeant Pharmaceuticals Intl Inc TLR7 Interferon alfa Sumitomo Dainippon Pharma Co Ltd IFNAR1; IFNAR2 Interferon alfa-1b Shenzhen Kexing Biotech Co Ltd IFNAR1 Interferon alfa-2a Cadila Healthcare Ltd IFNAR1; IFNAR2 Interferon alfa-2b Merck & Co Inc IFNAR1; IFNAR2 Interferon beta Toray Industries Inc IFNAR1 Interferon gamma-1a Otsuka Pharmaceutical Co Ltd IFNAR1 Therapy type Name of Therapy Company Target Cancer vaccine (7 in total) BCG Live Shire Plc TLR ImmuCyst Sanofi TLR Immuno BCG Ataulpho Paiva Foundation TLR Mycidac-C Cadila Pharmaceuticals Ltd TLR2 Sipuleucel-T Dendreon Unspecified TAA TICE BCG Merck & Co Inc TLR Uro-BCG Medac Inc TLR Cell therapy (2 in total) Tisagenlecleucel Novartis AG CD19 Axicabtagene ciloleucel Gilead CD19 Oncolytic virus (2 in total) Oncorine Shanghai Sunway Biotech Co Ltd CD40L Talimogene laherparepvec Amgen Inc GMCSFR CD3-targeted bispecific ab Blinatumomab Amgen Inc CD19 X CD3 Page 3 Annals of Oncology Dec 2017 Tang, Shalabi, Hubbard-Lucey
  4. 4. Therapy type_JT_.. 0 50 100 150 200 250 300 350 Number of Records T-cell targeted immunomodulator Other immunomodulator cancer vaccine Cell therapy oncolytic virus BiTE 144130 112 34 72 54 12 24 30 12 33 22 42 29 96 16 24 12 4 5 2 5 1 2 2 7 8 6 A REVOLUTION IS UNDERWAY: 2,004 IO AGENTS IN DEVELOPMENT 940 AGENTS ARE IN CLINICAL STAGES, AND 1,064 IN PRECLINICAL Therapy type_JT_AS .. 050100150200250300 Number of Records Checkpoint-activator Immunomodulator Cancer vaccine Cell Therapy Oncolytic virus BiTE 0 5050100150200250300350 100 150 200 250 300 350 Number of Agents 199 284 261 179 95 46 Other immunomodulator T-cell targeted immunomodulator Cancer vaccine Cell therapy Oncolytic virus CD3-targeted bispecific antibody Clinical agent count 99 170 344 224 69 34 Clinical stage Approved Phase III Phase II Phase I/II Phase I Preclinical & Discovery Page 4 Annals of Oncology, Dec 2017 Tang, Shalabi, Hubbard-Lucey
  5. 5. Target 0 10 20 30 40 50 60 70 80 90 100 110 120 Number of Clinical Agents Unspecified TAA CD19 PD-1 HER2 NY-ESO-1 PD-L1 CD20 CD40 EGFR CSF1R GD2 WT1 IFNAR1 MUC1 PSMA TERT Survivin HPV E6 Personalization BCMA CEA LAG-3 OX40 TLR TLR7 CD123 GITR GPC3 HPV E7 IDO1 IL2 mesothelin PSA TLR9 CD22 CD30 CD47 MAGE-A3 ADORA2A CD25 34 12 10 10 57 13 11 14 13 11 11 11 12 13 19 98 5 6 7 7 1 1 2 4 5 5 9 5 8 9 3 1 6 6 2 7 3 2 8 1 4 8 9 7 6 3 6 9 9 2 4 5 8 1 5 5 1 6 7 7 2 1 3 3 2 1 1 1 4 4 7 1 3 2 1 3 1 271 IO TARGETS IN CLINICAL TESTING, BY 462 DIFFERENT ENTITIES TOP 40 LISTED BELOW Therapy type T-cell targeted immunomodulator Other immunomodulator Cancer vaccine Cell therapy Oncolytic virus CD3-targeted bispecific mAb Page 5 Annals of Oncology, Dec 2017 Tang, Shalabi, Hubbard-Lucey
  6. 6. 0 2020406080 40 60 80 100 Number of Agents 98 51 13 Country (gr.. 020406080 Number of Clinical Agents China USA Other Country (gr.. 0 20 40 60 80 100 Number of Clinical Agents China USA Other 8 37 32 1 2 1 4 10 64 1 2 23 76 30 Clinical stage Approved Phase III Phase II Phase I/II Phase I Preclinical & Discovery Clinical agent count China US Other CAR-T CELL THERAPY LANDSCAPE CRI FOLLOWING 291 AGENTS, WITH 162 ALREADY IN CLINICAL TESTING Page 6 Annals of Oncology, Dec 2017 Tang, Shalabi, Hubbard-Lucey
  7. 7. PD-1/L1 AGENTS WILL CONTINUE TO BE TRANSFORMATIONAL …. BUT AN URGENT NEED FOR EFFICIENCIES Page 7
  8. 8. CRI FOLLOWING 164 PD-1/L1-TARGETING AGENTS 50 CLINICAL STAGE AGENTS (34 MONOCLONAL ANTIBODIES) Page 8 Preclinical & Discovery Phase I Phase I/II Phase II Phase III Approved 0 20 40 60 80 100 120 Number of Records 59 15 27 20 3 5 8 4 6 1 1 2 1 3 9 114 30 3 9 3 5 Molecule type Monoclonal antibody Bispecific antibody Small molecule Other biologic Therapy type - Split 2 (group) Monoclonal antibody Bispecific antibody small molecule Other biologic Annals of Oncology, Dec 2017 Tang, Shalabi, Hubbard-Lucey
  9. 9. INCREASE OF NEW PD-1/L1 COMBO TRIALS 2009 2010 2011 2012 2013 2014 2015 2016 2017 Number of new trials Planned new enrollment Trial Start Year 1 136 5 2,473 2 582 13 4,867 20 5,031 58 11,276 190 39,821 329 46,153 469 52,539 Clinical phase Phase 4 Phase 3 Phase 2 Phase 1/2 Phase 1 Page 9 Annals of Oncology, Dec 2017 Tang, Shalabi, Hubbard-Lucey
  10. 10. PD-1/L1 COMBO PARTNER ANALYSIS 165 DIFFERENT TARGETS ARE BEING COMBINED Page 10 CTLA-4 251 Chemotherapy 170 Radiotherapy 64 VEGFA 43 Chemoradio therapy 42 Numbers of Trials Using Common Combo Strategies: 1. Anti-CTLA-4 agents: 251 2. Chemotherapies: 170 3. Radiotherapies: 64 4. Anti-VEGFA agents: 43 5. Chemoradiotherapy combos: 42 Annals of Oncology, Dec 2017 Tang, Shalabi, Hubbard-Lucey
  11. 11. PD(L)-1 STUDIES ARE MOSTLY SMALL, SINGLE CENTER TRIALS 655 450 Number of Trials (1,105 in total) Sponsorship Non-industry-sponsored trials Industry-sponsored trials Page 11 Annals of Oncology, Dec 2017 Tang, Shalabi, Hubbard-Lucey
  12. 12. INNOVATION LIVES IN ACADEMIC CENTERS… Page 12 First approved CAR-T therapy First approved tissue-agnostic cancer therapy Multiple PDL-1 + CTLA-4 Ph3 Trials
  13. 13. MASTER PROTOCOLS ENABLING FASTER AND MORE COST EFFICIENT CLINICAL INFRASTRUCTURE Page 13 Build Multi-Lanes (in one trial) Drive Multiple (combos) Get Multiple Results Keep Highway OPEN Build 1 Highway (Trial) Drive 1 Car (Recruit) Get to 1 Result Dismantle the Highway 50% of study costs to build trial 9-12 mos to start OLD 1 Question = 1 Study = 1 Result NEW 1 Platform = Multiple Questions
  14. 14. CRI: FUNDING THE FULL SPECTRUM OF IO INNOVATION CLINICAL ACCELERATOR CULTIVATES INNOVATION, COLLABORATION, INTEGRATION Page 14 CRI Irvington Postdoctoral Fellowship Basic laboratory research and early training for young scientists Clinic and Laboratory and Integration Program (CLIP) Translational research grants to top investigators Clinical Accelerator Clinical trials of promising cancer immunotherapies Cancer Immunotherapy Consortium (CIC) Biopharma think tank addressing late-stage development issues The Answer to Cancer Patient and caregiver resources and clinical trial finder Impact Grants Directed funding to advance solutions to scientific and technological challenges
  15. 15. GLOBAL IMMUNO-ONCOLOGY COLLABORATION PARTNERING CRI IO EXPERTISE WITH CCTG GLOBAL CLINICAL AND OPERATIONAL EXCELLENCE Page 15 Press Release Jan 8, 2018 65 year legacy in tumor immunology $357m funding Proven speed and cost effectiveness Near 40 year legacy leading practice changing trials Global footprint: over 500 trials in over 40 countries Global IO expert network Efficiently evaluate the most promising immunotherapies on a global scale

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