Transgene Sa · EURONEXT:TNG
Transgene Sa — Rodman & Renshaw Techvest Global Healthcare Conference 2004
23 slides from Transgene Sa's conference presentation, May 12, 2004
Slide 1: Rodman & Renshaw Techvest Global Healthcare Conference
transgene I m m u n o t h e r a p y t o f i g h t c a n c e r Rodman & Renshaw Techvest Global Healthcare Conference Philippe PONCET Chief Financial Officer May 12-14, 2004 Good morning Ladies and Gentlemen. Thank you for being here so early to listen to the presentation of Transgene. I am Philippe
Slide 2: Forward Looking Statement
Forward Looking Statement §This presentation contains forward-looking statements, including statements regarding Transgene’s strategy and prospects. Statements that are not historical facts are based on the Company's current expectations, beliefs, estimates, forecasts and assumptions. The statements
Slide 3: Corporate Overview
Corporate Overview Development-stage biopharmaceutical company focused on cancer Product candidates based on proprietary gene transfer technology GMP-compliant manufacturing facilities Listed on Euronext Nouveau Marché (FR0005175080) and Nasdaq (TRGNY) 3 transgene Transgene is a development-stage co
Slide 4: Key Data
Key Data Headcount: 165 (30 PhD’s) Sites: Strasbourg (France) and Boston (USA) Mérieux Group Shareholders: (70.3%) (5.9%) Human Genome Sciences Free Float (2.2%) Areva (19.5%) (2.1%) French Muscular Dystrophy Association Financials: Market capitalization: € 104 M (04/16/04) Cash-on-hand: € 34.9 M (1
Slide 5: Management
Management Dr. Christophe MERIEUX Chairman - Medical Doctor Jean-François CARMIER - VP, Research and Medical Affairs Chief Executive Officer (bioMérieux) - Doctorate in Pharmacy - EVP, Industrial Operations (bioMérieux-Pierre Fabre) - Corporate Controller Rémi GLOECKLER (Pasteur Mérieux sérums&vacci
Slide 6: Gene Transfer Technology
Gene Transfer Technology Simplified mechanism of gene transfer technique 1 1 Insertion of a gene into a vector 2 2 Contact vector / targeted cell a 3 Entry and transport of the gene into the nucleous of the cell 3 4 Transcription of the mRNA from the gene b 5 Translation of the mRNA into a therapeut
Slide 7: Strategies to treat cancer: Vaccines
Strategies to treat cancer Vaccines Targeting specific tumoral antigens: MUC1 and HPV 7 transgene Transgene’s strategy to treat cancer is based on 3 approaches. First, anti-cancer vaccination: Tumor antigens are antigens that are expressed by tumor cells but are not recognized as abnormal by the bod
Slide 8: Strategies to treat cancer: Immune enhancement
Strategies to treat cancer IL2 IFNγ Immune enhancement Using Interleukin 2 (IL2) and Interferon gamma (IFNγ) 8 transgene Second, Immune enhancement which aims to stimulate the immune system globally, thereby helping the host to destroy the cancer cells. To this end, our products, adminstered intra-t
Slide 9: Strategies to treat cancer: Tumor killing
Strategies to treat cancer 5-FU Tumor killing Converting non-toxic 5-FC Into chemotherapeutic 5-FU 9 transgene Our last approach is what we call a suicide gene directed chemotherapy. Our product aims at converting a non toxic pro-drug into a toxic compound within the tumor. 9
Slide 10: Cancer Portfolio
Cancer Portfolio Indication Preclinical Phase I Phase II Phase III Cancer vaccines MVA-MUC1-IL2 Lung, Kidney, Prostate cancers MVA-HPV-IL2 Cervical Intra-epithelial Neoplasia (CIN) Immunotherapy products Ad-IL2 Malignant Melanoma and other solid tumors Ad-IFNγ Cutaneous T Cell Lymphoma Tumor-targete
Slide 11: MVA-MUC1-IL2: Product Design
MVA-MUC1-IL2: Product Design Cancer Vaccine ü Non-invasive treatment ü Subcutaneous administration Recombinant MVA (Modified Virus Ankara) ü non-replicative, highly immunogenic poxvirus Expressing MUC1 tumor-associated antigen ü MUC1 is found in most adenocarcinoma Expressing human IL-2 cDNA ü stimu
Slide 12: Cancer Vaccine: MVA-MUC1-IL2 Phase II Interim Results
Cancer Vaccine: MVA- MVA-MUC1- MUC1-IL2 Phase II – Interim results Lung Combination with chemotherapy Final results mid-2004 12 evaluable patients 5 PR (1stage IIIb; 4 stage IV) Response duration : 144 – 195 days Prostate Monotherapy / 2 dosing schedules Final results mid-2004 21 enrolled patients S
Slide 13: MVA-HPV-IL2: Product Design
MVA-HPV-IL2: Product Design Cancer Vaccine ü Non-invasive treatment ü Subcutaneous administration Recombinant MVA (Modified Virus Ankara) ü non-replicative, highly immunogenic poxvirus Expressing early genes E6/E7 of HPV16 ü virtually all cervix cancer are related to HPV (more than half to HPV16) ü
Slide 14: Cancer Vaccine: MVA-HPV-IL2 Phase II Results
Cancer Vaccine: MVA- MVA-HPV- HPV-IL2 Phase II results CIN 2-3 Vaccination prior to conization 27 evaluable patients High dose: 5 PR out of 15 patients Low dose: no CIN regression in 12 patients Cervical Monotherapy cancer Amendment combination chemotherapy 2 disease stabilizations; 2 PR with chemot
Slide 15: Immunotherapy: Ad-IFNγ
Immunotherapy: Ad-IFNγ Ad-IFNγ Phase I/II ü Cutaneous lymphoma (36 000 patients EU+US) ü Study design Dose escalation 9 3 dose levels 3.10 tp → 3.1011 tp 3 patients / dose level ü Treatment plan Intra-tumoral administration Weekly injections (D1, D8, D15 and tumor evaluation week) Maximum 4 cycles o
Slide 16: Multiple tumors treated at the fractionated MTD
Before Adeno-IFNγ After Adeno-IFNγ (9 injections) Multiple tumors (maximum of 3) treated at the fractionated MTD 16 I-C 002 transgene 16
Slide 17: Immunotherapy: Ad-IL2
Immunotherapy: Ad- Ad-Il2 Phase I/II ü Melanoma and other solid tumors ü Study design Dose escalation 8 5 dose levels 3.10 tp → 3.1011 tp 3 patients / dose level ü Treatment plan Intra-tumoral administration Every 3 weeks for the first 7 injections then every 6 weeks Phase I – II → 3.1011 tp weekly
Slide 18: Tumor-targeted chemotherapy: MVA-FCU1
Tumor-targeted chemotherapy: MVA- MVA-FCU1 Bystander effect A promising approach ü Deliver 20x higher concentrations of chemotherapeutic 5-FU in the tumor ü Avoid side-effects of 5-FU systemic administration Ongoing developments: Phase I planned for end of 2004 / beginning of 2005 in hepatic metasta
Slide 19: Gene therapy: Plasmid-dystrophin
Gene therapy: Plasmid- Plasmid-dystrophin Phase I § Indication: Duchenne/Becker’s muscular dystrophy § Funded by French Muscular Dystrophy Association § Phase I completed end of 2002 ü expression of dystrophin detected ü no immune reaction against the plasmid or the newly expressed dystrophin Futher
Slide 20: Significant upcoming milestones
Significant upcoming milestones 2004: Q3 Final results NSCL cancer with MVA-MUC1-IL2 Q3 Final results kidney cancer with MVA-MUC1-IL2 H2 Launch of Phase II in CIN 2-3 (high dose, conisation 6 months) H2 Regulatory approvals for pivotal study with Ad-IFNγ in cutaneous lymphoma 2005: Ad-IFNγ launch of
Slide 21: Statements of Operations
Statements of Operations US GAAP; in € million 2003 2002 Revenues 2.5 2.2 Operating expenses (24.6) (22.7) R&D (20.3) (19.1) G&A (4.3) (3.6) Restructuring 0.1 - Loss from operations (22.0) (20.5) Interest income 1.1 2.0 Income tax benefit - - Net loss (20.9) (18.5) Financial visibility: mid-2005 200
Slide 22: Our strengths
Our strengths § Clinical data support further development of all four cancer product candidates § Ad-IFNγ to be developed in-house § The mastering of 3 vector families § In-house manufacturing and controls of clinical lots § Opportunities to extract value from our technology and manufacturing platfo
Slide 23: Transgene contact details
Transgene 11 rue de Molsheim 67082 Strasbourg Cedex France Contact : poncet@transgene.fr Tel : +33-(0)3.88.27.91.02 Web Site : www.transgene.fr 23 transgene Thank you for your attention. We will be happy, Serge Braun our Scientific director and I to answer your questions in the breakout session in r
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