PART 2: PRODUCT PIPELINE Investor & Press Presentation Paris, 11th March 2009
Cautionary note regarding forward-looking statements This presentation contains forward-looking statements referring to the planned clinical testing and development of Transgene’s therapeutic vaccine candidates, and the possible entry into new partnership agreements.. However, clinical testing and successful product development depend on a variety of factors, including the timing and success of future patient enrolment and the risk of unanticipated adverse patient reactions. Results from future studies with more data may show less favorable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval or commercial use Furthermore, the entry into new partnerships involves a process of negotiation with partner candidates, including with respect to financial, technical, commercial and legal matters, and there is no certainty that appropriate partnerships will be established or will be successful.. For further information on the risks and uncertainties involved in the testing and development of Transgene’s product candidates, see Trangene’s Document de Référence on file with the French Autorité des marchés financiers on its website at http://www.amf-france.org and Transgene’s website at www.transgene.fr .
TABLE OF CONTENTS Slide 1. Key Events 4 2. Product Update • Pipeline Summary 5 • TG4010 (NSCLC) 6 • TG4040 (HCV) 22 • TG4001 (HPV) 25 • TG1042 (Onco-Dermatology) 28 • TG4023 (HCC and mCRC) 31 3. Business Outlook 37 4. Pipeline News Flow 38 3 11/03/2009
Summary of Key Events 2006 2005 2007 2008 � New Management � €18m OSEO grant – � €14.3m raised (warrants � Partnership with Roche � New Strategy � €100m capital increase exercised) Biomarker program � Portfolio Refocus � Phase IIb NSCLC � €34.9m capital increase � Launched phase IIb trial � Launch of Phase I in trial for TG4010 in NSCLC (TG4010) HCV (TG4040) meets primary endpoint � Positive results � Start of partnership � Positive phase II results � Recruitment for Phase II Phase I/II CBCL/CTCL trial in HPV trial (TG4001) trial in NSCLC and discussions for TG4010 (TG1042 ) CBCL franchise � Phase II CBCL trial � Promising TG4010 phase IIa meets primary endpoint results in solid tumors � Seeking partner for TG1042 franchise � Positive Phase I Conclusion: A substantial reinforcement of the company preliminary results ► Roche partnership validates strategy and technology from HCV trial France ► Cash position covers some 3 years of operations (TG4040) � Launch 2 nd phase I trial ► Refocus of product portfolio delivering desired clinical results for HCV (TG4040) in Canada 4 11/03/2009
Portfolio of Products in Development PRODUCT ► Indication Preclinical Phase I Phase II Phase III Partnership Strategy TG4010 Non Small Cell Lung Currently seeking Cancer a Partner (MVA-MUC1-IL2) Treatment of TG4001/R3484 precancerous lesions (MVA-HPV-IL2) of the cervix caused by the HPV virus Seeking partnership in Cutaneous B Cell broader onco- TG1042 Lymphoma dermatological (Ad-IFN γ ) franchise. TG4040 Chronic Hepatitis C Sole development up (MVA-HCV) to proof of concept Metastatic Colerectal Sole development up TG4023 Cancer to proof of concept (MVA-FCU1) Hepatocarcinoma 5 11/03/2009
TG4010 a Promising Vaccine to fight Cancer CONSTRUCTION TARGET MARKET AND MECHANISM OF ACTION MVA + MUC1 + IL2 ► First line treatment of metastatic non small immunogenic tumoral cytokine cell lung cancer (NSCLC) in combination vector antigen adjuvant with chemotherapy ► Other NSCLC stage of diseases and all ► A targeted immunotherapy for epithelial cancers expressing MUC1 the treatment of MUC1 (prostate, breast, kidney etc.) positive tumors ► Sub-cutaneous injection 6 11/03/2009
TG4010 / MVA-Muc1-IL2 MUC1 Protein Definition - Expression In Major Cancers ��� ��� ��� ��� ����� ����� ����� ����� ������ ������ ���� ������ ���������� ������ ������ �������� ������ ��� ��� ��� ��� ����� ����� ����� ����� ���������� ������ ������� ������ ������� ������ �������� ������ 7
TG4010: A Wide Range of Potential Indications Addressable Population Unmet Need Annual Incidence Selection of potential Sub-indications Disease burden, recent drug approvals (EU / US / Japan) ~ 280 000 High NSCLC IIIB/IV Prostate Cancer – ~ 100-120 000 High Hormone Refractory Prostate Cancer – Early ~ 350-400 000 Low Stage I & II ~ 50 000 Moderate NSCLC IIIA unresectable Colorectal Cancer – Advanced ~ 70-90 000 Moderate Stage IV ~ 100-150 000 High Breast Cancer – Advanced ~ 30-50 000 High Pancreatic Cancer - Advanced Breast Cancer – Early ~ 300-350 000 Moderate Stage 0, I, II 8 11/03/2009
TG4010: Global NSCLC Incidence NSCLC Incidence data (ww) - 2008 No of Patients, 000 223 US Europe Japan Other Developed Developed countries countries 233 ~40% of ~40% of global global Incidence Incidence 829 67 NSCLC: the cancer with the highest incidence: >1.3m • Developed countries are weighting ~40% of global incidence • 9 Source : Globocan, National Cancer Institute, L.E.K. interviews & analysis 11/03/2009
TG4010: Global Lung Cancer Mortality ► Lung cancer = NSCLC (80%) + SCLC (20%) ► Highest mortality among cancers: 1.18 million deaths/yr . ~25% of all cancer deaths worldwide (more than colon, breast and prostate cancers combined) ► Europe: ● 334,800 deaths in 2006 [Ferlay J et al. Annals of Oncology Advance Access, Feb 7, 2007] ● 253,300 men, representing 27% of total cancer deaths ● 81,500 women, representing 11% of total cancer deaths ► USA: ● 160,390 deaths in 2007 [National Cancer Institute] ● 161,840 deaths expected in 2008: 90,810 men and 71,030 women Lung cancer is the leading cause of cancer deaths in both men and women (worldwide) 10
TG4010: Therapeutic Intervention Points (TIP) for NSCLC NSCLC NSCLC Stage IA Stage IB Stage II Stage IIIA Stage IIIB Stage IV Stage IA Stage IB Stage II Stage IIIA Stage IIIB Stage IV Resectable Cancer Unresectable Cancer Performance Status = 0-2 Performance Status = 3-4 Resectable Cancer Unresectable Cancer Performance Status = 0-2 Performance Status = 3-4 TIP 2 Platinum-based Chemotherapy + bevacizumab Surgery Surgery Surgery Surgery Chemoradiation TIP 3 Surgery Surgery Surgery Surgery (~30-40% of patients eligible for bevacizumab ) 2 nd Line Treatment TIP 4 (Tarceva, Alimta, Taxotere) TIP 1 Platinum-based Adjuvant Chemotherapy + Radiation 3rd Line Treatment TIP 5 (Tarceva, Taxotere) Observation with follow-up Observation with follow-up Observation with follow-up Observation with follow-up No Yes No Yes Supportive/ Supportive/ Recurrence Return to Tx path Recurrence Return to Tx path Palliative Care Palliative Care Chemotherapies Gemzar/ Taxol/ Navelbine/ Alimta Chemotherapies Targeted Targeted Erbitux / TG4010/ Avastin / therapies / therapies / Merck Transgene Genentech Add-on Add-on 11 11/03/2009
TG4010: Histological Types of Lung Cancers Small cell anaplastic carcinomas (SCLC): SCLC Agressive and invasive Early metastasis 20% Adenocarcinomas : Glandular cell non- 45% anaplastic carcinomas 10% Large cell carcinomas : including bronchial NSCLC Same outcome as carcinoïds adecarcinomas Incidence 25% Squamous cell carcinomas : Epidermoid and non-anaplastic carcinomas Incidence • NSCLC represent ~ 80% of Lung cancers • NSCLC is a heterogeneous aggregate of histologies: the most common histologies are adenocarcinoma epidermoid, squamous cell carcinoma and large cell carcinoma • These histologies are often classified together because approaches to diagnosis, staging, prognosis and treatment may in some cases be similiar 12 11/03/2009
TG4010: Competitive Product Positioning in Metastatic (IIIb/IV) NSCLC Current chemotherapies Current chemotherapies Gemzar/Alimta (Ely Lilly) Other therapies Other therapies Navelbine (Pierre Fabre) Others Taxol (Bristol Myers) Erbitux (Merck) 13% Gemzar/Alimta (Ely Lilly) Squamous Navelbine (Pierre Fabre) Adenocarcinoma cell carcinoma Taxol (Bristol Myers) Avastin (Genentech) 56% 31% Gemzar (Ely Lilly) Erbitux (Merck) Taxol (Bristol Myers) Navelbine (Pierre Fabre) Erbitux (Merck) Ref: Scagliotti study (JCO July 2008), FLEX study (ASCO 2008), ECOG4599 retrospective analysis (JTO 2008 suppl #4) ► ������� ��������������������������������������� ��������������������������������� ������������������ !��"������# ► $�%���& ���������������������������������� 13 11/03/2009
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