CpG oligonucleotides TLR9 agonists
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Transcript CpG oligonucleotides TLR9 agonists
Biotech to Big Pharma
Personal Experience
Heather Davis
September 27, 2011
Ottawa, Canada
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Coley’s founding technology:
CpG oligonucleotides TLR9 agonists
Initial discovery was finding the molecular pattern in
bacteria and DNA viruses that turns on the immune
system shortly after infection
Specific DNA sequence known as “CpG motifs”
Activate through Toll-like receptor 9 found on certain
immune cells
Coley discovered and developed synthetic CpG drugs
Platform technology with wide potential applications
Adjuvants for vaccines
• Made current vaccines work better – can use lower
doses (antigen sparing important during pandemic)
• Allowed development of new types of therapeutic
vaccines
Cancer immunotherapy
Treatment for asthma and allergy
2
Coley’s Technologies
Original technology
Licensed from founders’
academic institutions
CpG
TLR9 AGONISTS
Cancers
– Solid
– Hematologic
Asthma & Allergy
Vaccine Adjuvant
New technology
Developed in-house
ANTAGONISTS
TLR7, 8, 9
Autoimmune and
Inflammatory
Disorders
– Lupus
– RA
Licensed from 3M after
much of original
technology licensed out
RNA AGONISTS
SMALL MOLECULES
TLR7, TLR8
Cancers
Infectious
Diseases
Coley’s TLR Therapeutics™ Platform Progression
3
Coley’s Timeline
Co-founded by Art Krieg (U Iowa), Heather Davis (U Ottawa / OHRI) and Joachim Schorr (Qiagen)
• Coley incorporated (1997 USA, 2001 Canada)
• Incubated in Krieg & Davis academic labs until 2003
PRE-CLINICAL
• CpG as vaccine adjuvant
• Oncology immune therapy & therapeutic vaccines
• Autoimmunity
CLINICAL
• 1st three CpG clinical (vaccine) studies run from Ottawa
LICENSING DEAL
• Cancer immune therapy clinical trials
• Hepatitis C immune therapy
• Lupus/RA immune therapy
Coley
acquired by
Pfizer
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
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4
Licensing Deals & Outcomes
PARTNER
GSK
GSK
Novartis
Merck
Other
Sanofi aventis
Pfizer
Indication
Total Deal
Milestones Received
by 2007
ID Vaccines
$62 M activity since
Took
to Phase 1 – no clinical
Cancer
Vaccines
In Phase
3 testing
$44 M
Vaccines
$35 M license
Took
to Phase 1 – cancelled
Vaccines
No
clinical testing
$33 M
$11.5 M
$9 M
$1.8 M
$4 M
M 1, ongoing activities
$21 M
Other
vaccines
Emergent
– completed $35
Phase
Asthma,
Took toallergic
Phase 1 – cancelled
$265 Mlicense
rhinitis
Cancer
Phasetherapy
3 trial failed
$515 M
$14 M
$65 M
5
How to succeed in biotech
Founder characteristics
Secure financing
Recruit senior management
Valuable technology, protected by IP
Luck & timing
6
Founder characteristics
Hard working, driven
Adaptable
Able to wear many hats
Successful transition from academia to corporate world
requires thinking differently
Hard working
7
Securing financing
Coley had 1 year funding from founder
Initial venture funding was Swiss / German
investors who had previously invested in corporate
founder
Subsequent rounds introduced US investors
No Canadian VC’s ever participated
Too late
Expected too much control for their investment
8
Recruit senior management
Founders rarely make good senior managers
Coley benefitted for 3 years by using senior management of
another company
Coley later hired own management team
Huge advantage having head office in Boston area
• Candidates with senior drug development experience are relatively rare in Canad
Critical hires since each represents a single point of failure
Drug development complex and only learned through experience
• Senior executives coming from Big Pharma sometimes couldn’t scale
down to biotech appropriate activities
9
Valuable technology
Technology must actually work
Positive clinical data trumps all
Selling technology on mouse data possible, but typically brings low
value or back-loaded deals
Platform technologies have greater chance to succeed
Need to know when to let go
Unrealistic for biotech company to expect to develop pharmaceutical
product to market
IP protection critical
Needs to be broad in scope and geography
IP protection costs escalate rapidly after provisional filing – difficult for
academic unit to sustain until alternate financing secured
10
Wild cards
Luck
Timing
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