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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

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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

    • 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 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

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

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

  • Founder characteristics

  • Secure financing

  • Recruit senior management

  • Valuable technology, protected by IP

  • Luck & timing


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

  • 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

  • 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

  • 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

  • Luck

  • Timing


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