ERBI Workshop introduction to CRTCRUK

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ERBI Workshop - introduction to CRT/CR-UK

• Phil LHuillier ? February 28, 2007

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Presentation format

• CRT/CR-UK who we are?
• How can we work with Industry
• CRT
• CR-UKs Drug Development Office (DDO)
• Clinical Development Partnerships (CDP)
• Case Studies
• Collaborations AstraZeneca and Manchester
  University
• Co-development (Discovery stage)
• Cellcentric
• Institute of Cancer Research and Vernalis
• Summary

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About Us -CRT

• Specialists in Oncology
• Oncology-focused technology development and
  commercialisation
• More than 20 years experience
• Wholly owned subsidiary of Cancer Research UK,
  the largest independent funder of cancer
• research in the world
• Global Network of Partners
• Unparalleled worldwide network of academic and
  commercial partners
• Exclusive rights to intellectual property from an
  annual research spend of over 480m
• Headquarters in London, US subsidiary in Boston
• Collaborative Development
• RD facility and partnerships with academic
  centres of excellence in drug discovery
• Broad portfolio of technologies available for
  licensing and co-development partnerships
• Expanding pipeline of partnered therapeutics and
  diagnostics

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Selected Partnered Therapeutics in Development

• CRT have more than 20 partnered agents in
  clinical development and 3 partnered marketed
  drugs

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Start-up Companies

• CRT has been involved in the formation and
  development of more than 18 start-ups

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Translational Development
Delivering attractive development opportunities
for biotech and pharma

• Discovery over 60 programmes under
• development
• Academic centres of excellence in drug
• discovery
• CRTs biotherapeutic and drug discovery
• laboratories
• Drug development
• Commercial partnerships worldwide
• Cancer Research UKs drug development
• infrastructure

Partnerships with research institutes and funding
bodies worldwide
Exclusive rights to Cancer Research UK funded
programmes
Academic centres of excellence in drug discovery
Clinical Development Partnerships
Cancer Research Technology
World Class Clinical Trials Network
CRT Development Laboratories
Strategic alliances with drug discovery
specialists
Development Funding
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Selected Academic Partners

• Partnerships with more than 20 charities and
  institutes worldwide
• Cancer Research UK
• Leukaemia Research
• Marie Curie Cancer Care
• Association for International Cancer Research
• Netherlands Cancer Institute
• Fred Hutchinson Cancer Center
• European Institute of Oncology
• Danish Cancer Society
• Deutsches Krebforschungszentrum
• Karolinska Institute
• Auckland Division Cancer Society of New Zealand
• University of Barcelona

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CRT Development Laboratories

• Industrially-focused biotherapeutic and drug
  discovery laboratories
• Collaborations worldwide focus on novel
  anti-cancer targets with leading academic
  research groups
• Develop small molecules and biotherapeutics to in
  vivo proof of efficacy stage
• Robust licensing opportunities and co-development
  programmes

CRT Bridges the Gap Between Academia and Industry
Assay Design and HTS
Market
Patient Benefit
Preclinical and Clinical Development
In vivo Proof of Principle
Hit to Lead and Lead Optimisation
Publicly Funded Research
Target Validation and Feasibility
Development Gap
Academia Funding
Commercial Partners
CRT Development Laboratories
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CRT Development Laboratories Portfolio
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Cancer Research UK

• Created out of merger between ICRF and CRC in
  2002.
• Total research spend of 254 million (2005/6).
• Support over 500 research groups.
• 3000 staff (including London Research
  Institute).
• Major influence on UK Government wrt policy
  initiatives on cancer treatment, prevention and
  scientific research.

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CRUK Drug Development Office

• Established in 1982.
• Manage preclinical development and sponsor phase
  I/II trials of novel anticancer drugs.
• Emphasis on deriving pharmacodynamic / biological
  information.
• Approximately 60 small molecules, though
  increasing number of Biologicals
• gt20 major international collaborators from
  Pharma, Biotech and Academia
• Taken over 100 agents into man for the first
  time.
• 4 products to market 3 products currently in
  phase III.

• Temodal (Temozolomide), Schering Plough - High
  grade glioma
• Etopophos (Etoposide Phosphate), Bristol Myers
  Squibb - Refractory testicular tumours and small
  cell lung cancer
• Lentaron (Formestane), Novartis - Advanced
  breast cancer
• Lozoxantrone (Biantrazole, DUP941/CI941),
  DuPont/Parke Davis - Advanced breast cancer

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CRUK Development Projects

• Take on 7-8 projects/year
• Aim to double this by 2010
• 30-40 projects at one time
• Projects approved by CRUK New Agents Committee
  (NAC).
• Peer review to ensure work on innovative
  products, incorporate high quality trial design
  and apply leading technologies.

• Current portfolio
• 6 - Exploratory development
• 5 - Regulatory preclinical/ Phase I trial
  preparation
• 23 - Phase I trial (recruiting and closed)
• 2 - Phase II preparation
• 2 - Phase II trial (recruiting and closed)

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Types of Drugs - a Preclinical and Clinical
Challenge!

• Small Molecules
• Antibodies
• Gene Therapies
• Vaccines
• Cell Therapies

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CRUK Drug Development - Resources and capabilities

• DRUG DEVELOPMENT OFFICE (ALBANY HOUSE LONDON)
• Multi-disciplinary capabilities in oncology
  therapeutics Research and Development
• Preclinical and Clinical Oncology Therapeutic
  Expertise
• Project Management
• Clinical Operations and Data Management
• Quality and Regulatory Affairs
• FORMULATION UNIT (STRATHCLYDE UNIVERSITY)
• Formulation development. GMP licensed facility
  for manufacture of formulated drug products.
• BIOTHERAPEUTICS DEVELOPMENT UNIT (CLARE HALL,
  HERTS)
• Process development. GMP licensed facility for
  manufacture of biologicals.
• NETWORK OF EXPERT CLINICAL AND LABORATORY CENTRES

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Working with CRUK DDO - Companies

• Currently working with around 11 biotechs (UK,
  Europe, US).
• Requirement for application to and approval by
  NAC.
• Reimbursement of CRUK costs or shared risk.
• Access to world class CRUK clinical network.
• More expert input into trial design,
  incorporation of leading technologies and lower
  costs than CROs.
• Preclinical development expertise, fully
  integrated clinical operations function, trial
  sponsor.

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Clinical Development Partnerships in a Nutshell

• Joint initiative between CRUK and CRT

• Targeted at leading pharma and biotech

• Bringing new life to deprioritised cancer agents

• Novel targeted small molecules and biological
  therapeutics

• Early clinical development at no cost to company

• Performed through an established clinical trials
  network

• Project undertaken on a shared risk-reward basis

• Aims to increase the number of new treatments
  for cancer

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Case Studies

• 1. Collaborations AstraZeneca and Manchester
  University
• Major strategic initiative on biomarker
  discovery and validation

Cancer Research Technology and The University of
Manchester Announce Clinical Pharmacology
Collaboration in Oncology with AstraZeneca
London, UK Manchester, UK, 20 November 2006
CRT, and The University of Manchester have
entered into an agreement with AstraZeneca to
establish a clinical pharmacology biomarker
research and discovery collaboration.
Collaboration..strengthening existing
collaborative links between AstraZeneca, CRT and
the Cancer Research UK core-funded Paterson
Institute for Cancer Research. Programme aims
to identify and validate circulating biomarkers
for use in conjunction with targeted cancer
therapies.
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Case Study Co-development (Discovery stage)
with CellCentric
CellCentric and Cancer Research Technology
Initiate Co-Development Partnership Cambridge,
UK. 26th September  2005.  CellCentric and CRT
begin an anti-cancer co-development programme. 
The programme of two phases aims to validate
CellCentrics novel and proprietary
epigenetic-related lead cancer target, and
subsequently develop monoclonal antibody
therapeutic products.   This is the first time
that CRTs expanded Development Laboratory has
collaborated with a commercial third party in
development of an external technology. Both
parties will share the costs and rewards of the
collaboration which may be followed by the
co-development of other targets identified by
CellCentric.
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Case Study Co-development (Discovery stage)
with Vernalis

• HSP90 Drug Discovery Collaboration - Institute of
  Cancer Research and CRT
• HSP90 is a molecular chaperone protein that is
  essential for the stability and function of
  several key oncogenic proteins.
• CRT collaborated with Prof Paul Workman and
  Laurence Pearl and their teams (at ICR) to
  initiate a drug discovery programme.
• At an early stage, Vernalis came on board as
  co-development partner and subsequently licensed
  programme.
• More recently programme has been licensed to
  Novartis for clinical development.

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PKD
Summary

• CR-UK
• very larger funder of basic (academic) research
  in cancer
• Broad clinical development capability able to
  work with academics and industry
• CRT
• Unique strategic model bridging gap between
  academia and industry
• Industrial style operation with small molecule
  and biological therapeutic capabilities
• Seeking partners for collaboration,
  co-development or licensing

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Thank you

• www.CancerTechnology.com