2024 03 Monumental Mistakes in EMS BAD EMS v0.2.pdf
IO Landscape Analysis - JPM18 - Aiman Shalabi
1. IO LANDSCAPE ANALYSIS
JPM18
JANUARY 9, 2018
AIMAN SHALABI PHARMD, MBA
CHIEF MEDICAL OFFICER
CLINICAL ACCELERATOR
PHILANTHROPIC VENTURE FUND
CANCER RESEARCH INSTITUTE
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. PD-1/L1 AGENTS WILL CONTINUE TO BE
TRANSFORMATIONAL
…. BUT AN URGENT NEED FOR EFFICIENCIES
Page 7
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. 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. 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. 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. 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. 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. 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. 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