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Biotech to Big Pharma Personal Experience. Heather Davis September 27, 2011 Ottawa, Canada. 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

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heather davis september 27 2011 ottawa canada
Biotech to Big Pharma

Personal Experience

Heather Davis

September 27, 2011

Ottawa, Canada

coley s founding technology cpg oligonucleotides tlr9 agonists
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
coley s technologies
Coley’s TLR Therapeutics™ Platform Progression

RNA AGONISTS

SMALL MOLECULES

TLR7, TLR8

ANTAGONISTS

TLR7, 8, 9

CpG

TLR9 AGONISTS

  • Cancers
  • Infectious Diseases
  • Autoimmune andInflammatory Disorders
    • Lupus
    • RA
  • Cancers
    • Solid
    • Hematologic
  • Asthma & Allergy
  • Vaccine Adjuvant
Coley’s Technologies

Original technology

Licensed from founders’

academic institutions

New technology

Developed in-house

Licensed from 3M after much of original technology licensed out

coley s timeline
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

4

licensing deals outcomes
Licensing Deals & Outcomes

Took to Phase 1 – no clinical activity since

In Phase 3 testing

Took to Phase 1 – cancelled license

No clinical testing

Emergent – completed Phase 1, ongoing activities

Took to Phase 1 – cancelled license

Phase 3 trial failed

how to succeed in biotech
How to succeed in biotech
  • Founder characteristics
  • Secure financing
  • Recruit senior management
  • Valuable technology, protected by IP
  • Luck & timing
founder characteristics
Founder characteristics
  • Hard working, driven
  • Adaptable
    • Able to wear many hats
    • Successful transition from academia to corporate world requires thinking differently
  • Hard working
securing financing
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
recruit senior management
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
valuable technology
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
wild cards
Wild cards
  • Luck
  • Timing
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