From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest...

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From PhD Project to Billion Dollar Deal Per Norlén, CEO 7 th December 2016

Transcript of From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest...

Page 1: From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest upside potential within the global pharmaceutical market 1 126 942 566 360 706 960

Strictly private and confidential

From PhD Project to Billion Dollar Deal

Per Norlén, CEO7th December 2016

Page 2: From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest upside potential within the global pharmaceutical market 1 126 942 566 360 706 960

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

Page 6: From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest upside potential within the global pharmaceutical market 1 126 942 566 360 706 960

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)

Page 7: From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest upside potential within the global pharmaceutical market 1 126 942 566 360 706 960

lab book notes, page 58, 1999 Nov 11

B44

ADC-1013 – First experiment in 1999

Page 8: From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest upside potential within the global pharmaceutical market 1 126 942 566 360 706 960

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

Page 11: From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest upside potential within the global pharmaceutical market 1 126 942 566 360 706 960

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

Page 12: From PhD Project to Billion Dollar Deal - Alligator Bioscience · The I/O market holds the largest upside potential within the global pharmaceutical market 1 126 942 566 360 706 960

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!