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

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Presentation on theme: "1 Heather Davis September 27, 2011 Ottawa, Canada Biotech to Big Pharma Personal Experience."— Presentation transcript:

1 1 Heather Davis September 27, 2011 Ottawa, Canada Biotech to Big Pharma Personal Experience

2 2 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

3 3 Coley’s TLR Therapeutics™ Platform Progression Coley’s Technologies CpG TLR9 AGONISTS  Cancers –Solid –Hematologic  Asthma & Allergy  Vaccine Adjuvant Original technology Licensed from founders’ academic institutions RNA AGONISTS SMALL MOLECULES TLR7, TLR8  Cancers  Infectious Diseases Licensed from 3M after much of original technology licensed out ANTAGONISTS TLR7, 8, 9  Autoimmune and Inflammatory Disorders –Lupus –RA New technology Developed in-house

4 4 4 Coley’s Timeline Coley acquired by Pfizer 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Coley incorporated (1997 USA, 2001 Canada) Incubated in Krieg & Davis academic labs until 2003 CLINICAL 1 st three CpG clinical (vaccine) studies run from Ottawa LICENSING DEAL Cancer immune therapy clinical trials Hepatitis C immune therapy Lupus/RA immune therapy PRE-CLINICAL CpG as vaccine adjuvant Oncology immune therapy & therapeutic vaccines Autoimmunity Co-founded by Art Krieg (U Iowa), Heather Davis (U Ottawa / OHRI) and Joachim Schorr (Qiagen)

5 5 Licensing Deals & Outcomes PARTNERIndicationTotal Deal Milestones Received by 2007 GSKID Vaccines$62 M$11.5 M GSKCancer Vaccines$44 M$9 M NovartisVaccines$35 M$1.8 M MerckVaccines$33 M$4 M OtherOther vaccines$35 M$21 M Sanofi aventis Asthma, allergic rhinitis $265 M$14 M PfizerCancer therapy$515 M$65 M 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

6 6 How to succeed in biotech Founder characteristics Secure financing Recruit senior management Valuable technology, protected by IP Luck & timing

7 7 Founder characteristics Hard working, driven Adaptable  Able to wear many hats  Successful transition from academia to corporate world requires thinking differently Hard working

8 8 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

9 9 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

10 10 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

11 11 Wild cards Luck Timing

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