From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest...
Transcript of From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest...
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Strictly private and confidential
From PhD Project to Billion Dollar Deal
Per Norlén, CEO7th December 2016
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Alligator develops agonistic antibodies for tumor directed immunotherapy
2001
2008
2012
2013
2015
Strategic focus on immuno-oncology
FIND® and foundation of Alligator
Focus extended to bispecific antibodies
ALLIGATOR-GOLD® antibody library
ADC-1013 entering clinical phase I & major out-licensing deal
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Source: Citi Research: “Immunotherapy - The Beginning of the End for Cancer”, A Baum, 22 May 2013; Bristol –Myers Squibb; Merck;
GlobalData
Sales of existing immuno-oncology treatments Projected immuno-oncology market development
Rapid development within the field of immuno-oncology
US$ Billion
The I/O market holds the largest upside potential within the global pharmaceutical market
1 126
942
566
360
706
960
1 369
2 634
2011 2012 2013 2014 2015
Yervoy® Opdivo® Keytruda®
21.5%
35.8%
42.8%
US$ Million
Treatment costs at ~150,000 annually per patient Market potential at US$ ~30 billion within 5-7 years
3
30
2015 2023E
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Immuno-oncology – using the immune system to kill cancer
Dendritic
cellT-cell
Metastases
Tumor
Cancer immunotherapy switches the balance from immunosuppression to immune activation,
resulting in immune-mediated tumor eradication
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Metastases
Tumor
Immune
activation
S Y S T E M I C I M M U N O - A C T I V A T I O N T U M O R - D I R E C T E D I M M U N O - A C T I V A T I O N
Tumor-directed immunotherapy
General immune activation with severe toxicity Tumor-selective immune activation with less toxicity
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Alligator drug development pipeline
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All product candidates suitable for combination therapy with other I-O drugs, e.g. anti-PD-1 and anti-PD-L1
RESEARCH PRE-CLINICAL DEVELOPMENT PHASE I PHASE II
TNFR-SF: Tumor Necrosis Factor Receptor-Superfamily
TAA: Tumor-Associated Antigen
ND: Not Disclosed
*Partnered with Janssen Biotech Inc., developed as JNJ-64457107
ADC-1013* (CD40)
ATOR-1015 (OX40/CTLA-4)
ATOR-1016 (TNFR-SF/TAA)
(TNFR-SF)
(TNFR-SF/ND)
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lab book notes, page 58, 1999 Nov 11
B44
ADC-1013 – First experiment in 1999
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Lead Optimization of CD40 Antibody
Affinity maturation using FIND®. Affinity improved from 1 to 0.01 nM.
Increased tumor retention through elevation of isoelectric pointAffinity/Off-rate
Binding maximum
ADC-1013
B44
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Source: Pardoll, Nature Reviews Cancer, 2012
Mode of Action Co-stimulating receptors
CD40 is a key immuno-oncology target
CD40 is a promising target for combination with T-cell activating antibodies such as PD-1
ANTIGEN-PRESENTING CELL T CELL
CD40
ADC-1013
ANTIGEN-PRESENTING CELL
+PDL1 or PDL2
PDL1 or PDL2
CD80 or CD86
CD80 or CD86
B7RP1
B7-H3
B7-H4
HVEM
MHC class I or II
CD137L
OX40L
CD70
CD40
GAL9
T CELL
+
–
+
–
+
–
–
–
–
–
+
+
+
–
–
?
PD1
CD28
CTLA4
ICOS
?
?
BTLA
KIR
TCR
LAG3
CD137
OX40
CD27
CD40L
TIM3
A2aR
Peptide
Adenosine
T-cell
Dendritic
cell
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Source: Company information
ADC-1013 clinical trial
40 patients with solid
tumors
5 clinical sites in UK,
DK and SE
Safety and tolerability
Primary
endpoint
PK & PD
Immunogenicity
Clinical efficacy
Secondary
endpoints
Dosing &
administration
FiH, first dose April 2015
Dose escalation
Intra-tumoral & intravenous
Source: Company information
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Partnership with Janssen
Source: Company information
Royalty / Milestone potential
Exclusive world-wide license
Alligator continues as sponsor for the ongoing Phase I clinical trial
Additional Phase I study initiated by Janssen
All development costs covered by Janssen
Description of agreement
Up-front payment plus additional milestones of up to US$ 700 million
Tiered high single digit to low double digit royalties on all future sales
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ADC-1013 out-licensing – success factors
Strong scientific rationale, internal
expertise and scientific collaborations
Well positioned: potential for first in class
and best in class
Extensive pre-clinical data package
Data package included all data
likely to be requested, including
strong benchmark data
Solid intellectual property
High quality development, no shortcuts
Timing and guts
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Strictly private and confidential
Thank You!