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Affitech Affitech Presentation Transcript

  • Life Science Seminar
    5. October 2011
    Martin Welschof
    Managing Director, Affitech A/S
    Affitech A/S, October, 2011
  • Disclaimer
    Forward Looking Statements
    Affitech A/S is a public company listed on NASDAQ OMX Copenhagen. Recipients of this presentation are advised that this written presentation and any verbal comments to it provided by Executive Management contain forward looking statements, including without limitation those regarding Affitech’s financial position, business strategy, news flow, plans and objectives for future operations, including development plans and objectives relating to our products. Such forward looking statements are based upon assumptions of future events which may not prove to be accurate and involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from those expressed or implied by such forward looking statements. In addition, the forward looking statements in this document speak only as of the date of this presentation
  • Company snapshot
    Affitech A/S, October, 2011
    • Promising lead drug candidates:
    • AT001/r84:A human selective anti-VEGF antibody with a new mode of action
    • AT008/CCR4: The first CBASTM antibody targeting a GPCR - advancing to candidate selection
    • Broad and growing pipeline of GPCR drug candidates
    • Powerful antibody discovery engine:
    • Unique proprietary technology platform, placing Affitech at the forefront of antibody innovation
    • Partnerships:
    • Strong strategic partnerships for research, co-development and marketing
  • Solid intellectual property platform
    Affitech A/S, October, 2011
    The Breitling patent
    • Worldwide exclusive rights covering certain aspects of phagemid display of human antibodies, acquired from the German Cancer Centre in Heidelberg
    Cell Based Antibody Selection – CBASTM patent
    • Granted patent in EU, Russia, Japan, New Zealand, South Africa, Singapore
    • Pending in USA, Australia, Canada, Israel, India, China, Brazil, Norway, Croatia, Serbia
    AT001/r84 patent
    • Patent pending in EU, EAPO, Ukraine, Japan, USA, China, India, South Korea, Singapore, South Africa, Israel, Brazil, Columbia, Mexico, Canada, Australia, New Zealand
    CCR4andCXCR4 patents
    • Applications filed (pre-PCT or early PCT phase) in the UK and USA
  • Exciting antibody pipeline
    Drug candidate
    (VascularEndothelialGrowth Factor)
    IBC Generium (Russia/CIS)
    Unpartnered in otherterritories
    CTA filed, Phase I trialsscheduled in 2011
    CCR4, a GPCR
    (G-protein coupled receptor)
    Cancer, autoimmune diseases
    IBC Generium (Russia/CIS)
    Unpartnered in otherterritories
    Beta2glycoprotein1 Phosphatidylserine
    Cancer, infectiousdiseases
    Peregrine Pharmaceuticals
    Not disclosed
    Cancer, infectiousdiseases
    Peregrine Pharmaceuticals
    Not disclosed
    In development
    CXCR4, a GPCR
    Severalother GPCR programs
    Cancer, inflammation
  • Powerfultechnology drives discoveryengine
    Platform withhighcapacity to isolate multiple fully human antibody
    candidates to targetswithchallengingspecificities
    CBASTM – cellbased antibody selection
  • AT001/r84 – potential for greater safety
    AT001/r84 antibody is a proprietary antibody with anovel mechanism of action:
    • A fully human antibody
    • Binds VEGF selectively, inhibiting binding to VEGFR2 only and not VEGFR1
    • Preclinical data shows efficacy at least equal to Avastin® (bevacizumab)
    • Shows limited induction of side effects
    Large market opportunity for AT001/r84 in
    emerging markets :
    • Potential to be a better “Avastin®”, which had sales of ~USD 5.9bn in 2009
    • Low penetration of Avastin® in Russia/CIS
    • An anti-VEGF antibody has top priority on Russian short list of innovative drugs to be marketed by 2015
    Affitech A/S, October, 2011
    Scheduled to enter phase I clinical trial in Russia in 2011
  • AT001/r84 – more specific inhibition (VEGF)
    More selective for anti-angiogenesis
    the dominant ‘angiogenic’ receptor
    Affitech A/S, October, 2011
  • AT001/r84 progressing well
    • First GMP manufacturing (through AVID) completed
    • Preparing Clinical Trial Application for submission
    • Collaboration agreement with Dr. Rolf Brekken(University of Texas Southwestern), for further mechanistic studies in disease models
  • GPCRs - major opportunity for antibody approach
    Affitech A/S, October, 2011
    • G-protein coupled receptors (GPCRs) can be used where inhibition by small molecule chemistry has proven difficult
    • Multi-ligandGPCRs can be targeted for antibody therapy
    • GPCRs - the largest known protein family at >2% of the entire genome
    • Involved in a wide range of disorders and biological functions
    • ~20% of current drugs target GPCRs but only a fraction of the cell surface receptors
  • AT008/CCR4 in progress
    A potential development candidate has been identified
    • Clinically validated target:
    • NDA filed in Japan for anti-CCR4 antibodyKW-0761 to treat Adult T-cell Leukemia-Lymphoma (ATL) (Kyowa Hakko Kirin, partnered with Amgen)
    • Preliminary proof of concept
    • A xenograph model successfully completed
    • Development of an AT008/CCR4 manufacturing cell line initiated
    • Six other chemokine receptor programs are being profiled in in vitro and in vivo models
    • Collaboration agreement with Professor Frances Balkwill, Cancer Research Technology Ltd. UK for further validation of the CCR4 target
  • Antibodies to GPCRs – potential indications
    Affitech A/S, October, 2011
    • Primary tumors in both hematological cancers and solid tumors
    • Metastatic lesions
    • Regulatory T cells (in stroma and circulation)
  • Affitech’s bispecific antibody program: BIMS
    Affitech A/S, October, 2011
    • BIMS – “Bispecific IgG-like Molecule of enhanced Selectivity”
    • Next generation dual specificity/functionality antibody-like molecules
    • BIMS is a molecule which has the size of a normal IgG antibody. Since it is tetravalent is has a longer half-life in circulation
  • Valuable strategic partnerships
    AT001/r84 and AT008. Fast track to market. Financing of clinical trials in Russia. Marketing in Russia and the other CIS countries. Affitechretainsworldwiderights. Opportunity to leverage into other emerging markets
    Collaboration on AT004 and AT005, in cancer and infectious diseases
    AT006 / Ang-2 program. Roche is using Affitech’s Ang-2 antibody in a bi-specific format with Avastin®
    GMP Manufacturing for AT001/r84
    IBC Generium
    Exploring further development partnerships in BRIC or other regions of the world
  • Excellent research collaborations
    Affitech A/S, October, 2011
    • Research collaboration with Professor Frances Balkwill, Cancer Research Technology Ltd. UK for further validation of CCR4 target
    • Research collaborationwith Dr. Rolf Brekken, University of Texas Southwestern Medical Center, Dallas, USA for furthermechanistic studies of AT001/r84 in disease models
  • Priorities and timelines - key milestones 2011
    Affitech A/S, October, 2011
  • Listing details
    Affitech A/S, October, 2011
    Listed on Nasdaq OMX Copenhagen (AFFI)
    • TransNova Inv. Ltd.: 40%
    • Krosalter Enterprises Ltd. 13,3%,
    • Norwegian PE and institutions: ~30%
    • Danish private investors: ~17%
  • A multicultural organization
    Affitech A/S, October, 2011
    30+ people, 27 scientists,  10 of which are PhDs
    Experienced international executive management team:
    • Managing Director Martin Welschof, German, one of Affitech’s founders
    • CFO Stig Jarle Pettersen, Norwegian state authorized public accountant
    • CSO Alexander Duncan, British, a leading antibody research scientist and business leader
    Facilities in Copenhagen Bio Science Park , Denmark and in the Research Park in Oslo, Norway
  • Contactdetails
    Affitech A/S, October, 2011
    Affitech A/S
    Copenhagen, Denmark
    c/o COBIS
    Ole Maaløes Vej 3
    DK- 2200 Kbh. N
    Telephone: +45 39 17 82 59
    Email: IR@affitech.comf
    Affitech Research, Oslo, Norway
    Gaustadalléen 21
    N-0349 Oslo
    Telephone: +47 22 95 87 58
    Fax: +47 22 95 83 58
  • Affitech A/S addresses unmet medical needs in cancer, including hematological and solid tumors,
    and in serious inflammatory conditions
    Thank you for your attention