from phd project to billion dollar deal - alligator bioscience · the i/o market holds the largest...
TRANSCRIPT
Strictly private and confidential
From PhD Project to Billion Dollar Deal
Per Norlén, CEO7th December 2016
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
3
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
4
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
5
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
Alligator drug development pipeline
6
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)
lab book notes, page 58, 1999 Nov 11
B44
ADC-1013 – First experiment in 1999
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
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
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
Strictly private and confidential
Thank You!