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1Affitech A/S, October, 2011
Life Science SeminarProinvestor
5. October 2011
Martin WelschofManaging Director, Affitech A/S
2
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
3Affitech A/S, October, 2011
Company snapshot
• 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
4Affitech A/S, October, 2011
Solid intellectual property platform
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
CCR4 and CXCR4 patents • Applications filed (pre-PCT or early PCT phase) in the UK and USA
5
Exciting antibody pipeline
Target
Anti-VEGF (Vascular Endothelial
Growth Factor)
CCR4, a GPCR(G-protein coupled
receptor)
Beta2glycoprotein1 Phosphatidylserine
Phosphatidylserine
Angiopoietin-2
CXCR4, a GPCR
Several other GPCR programs
Drug candidate
AT001/r84
AT008/CCR4
AT004
AT005
AT006
AT009
Disease area
Cancer
Cancer, autoimmune
diseases
Cancer, infectious diseases
Cancer, infectious diseases
Cancer
Cancer
Cancer, inflammation
Partner
IBC Generium (Russia/CIS)
Unpartnered in other territories
IBC Generium (Russia/CIS)
Unpartnered in other territories
Peregrine Pharmaceuticals
Peregrine Pharmaceuticals
Roche
Unpartnered
Unpartnered
Status
CTA filed, Phase I trials scheduled in
2011
Preclinical testingCandidate selected
Not disclosed
Not disclosed
In development
Research
Research
6
Powerful technology drives discovery engine
Antibody library; ~
10bn different
molecules
Antibody formats including BIMS –
multispecific format
MBASTM –
molecule
based
antibody
selection
CBASTM – cell based antibody selection
Platform with high capacity to isolate multiple fully human antibody candidates to targets with challenging specificities
7Affitech A/S, October, 2011
AT001/r84 – potential for greater safety
Scheduled to enter phase I clinical trial in Russia in 2011
AT001/r84 antibody is a proprietary antibody with a novel 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 effectsLarge market opportunity for AT001/r84 inemerging 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
8Affitech A/S, October, 2011
AT001/r84 – more specific inhibition (VEGF)
the dominant ‘angiogenic’ receptor
VEGFR1 VEGFR2VEGFR1 VEGFR2
Avastin® AT001/r84More selective for anti-angiogenesis
9
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
10Affitech A/S, October, 2011
GPCRs - major opportunity for antibody approach
• G-protein coupled receptors (GPCRs) can be used where inhibition by small molecule chemistry has proven difficult
• Multi-ligand GPCRs 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
11
AT008/CCR4 in progress
A potential development candidate has been identified
• Clinically validated target:• NDA filed in Japan for anti-CCR4 antibody KW-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
12Affitech A/S, October, 2011
Antibodies to GPCRs – potential indications
•Primary tumors in both hematological cancers and solid tumors
•Metastatic lesions
•Regulatory T cells (in stroma and circulation)
13 Affitech A/S, October, 2011
Affitech’s bispecific antibody program: BIMS
•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
14
Valuable strategic partnerships
IBC Generium AT001/r84 and AT008. Fast track to market. Financing of clinical trials in Russia. Marketing in Russia and the other CIS countries. Affitech retains worldwide rights. 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
Exploring further development partnerships in BRIC or other regions of the world
15Affitech A/S, October, 2011
Excellent research collaborations
• Research collaboration with Professor Frances Balkwill, Cancer Research Technology Ltd. UK for further validation of CCR4 target
• Research collaboration with Dr. Rolf Brekken, University of Texas Southwestern Medical Center, Dallas, USA for further mechanistic studies of AT001/r84 in disease models
16Affitech A/S, October, 2011
Priorities and timelines - key milestones 2011
Program Task Status
AT001/r84 Finalizing Reports and file Clinical Trial Application (CTA) in Russia, together with IBC Generium in 2011
Preparing the CTA
AT008/CCR4 Select antibody drug candidate for AT008/CCR4
Selected
Complete pre-clinical testing of a panel of drug candidates
Ongoing
Partners Enter into more partnerships potentially in BRIC or other emerging markets
Ongoing
Technology Extend antibody library sizeDevelop the BIMS technologyAccess ADCC enhancing technology
Ongoing
17Affitech A/S, October, 2011
Listing details
Listed on Nasdaq OMX Copenhagen (AFFI)
Ownership: • TransNova Inv. Ltd.: 40% • Krosalter Enterprises Ltd. 13,3%, • Norwegian PE and institutions: ~30%• Danish private investors: ~17%
18Affitech A/S, October, 2011
A multicultural organization
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
19Affitech A/S, October, 2011
Contact details
Affitech A/S Copenhagen, Denmark
c/o COBISOle Maaløes Vej 3DK- 2200 Kbh. N
DenmarkTelephone: +45 39 17 82 59Email: [email protected]
Affitech Research, Oslo, NorwayGaustadalléen 21
N-0349 OsloNorway
Telephone: +47 22 95 87 58Fax: +47 22 95 83 58
Email: [email protected]
WWW.affitech.com
20
Affitech A/S addresses unmet medical needs in cancer, including hematological and solid tumors,
and in serious inflammatory conditions
Thank you for your attention