Transgene SA · EURONEXT:TNG
Transgene SA — Euro-Biotech Forum 2003
16 slides from Transgene SA's conference presentation, Jun 2, 2003
Slide 1: Euro-Biotech Forum 2003
Michel HUBERT VP, Business Development Euro-Biotech Forum 2003 Paris, June 2nd, 2003
Slide 2: Key Facts
Key Facts 1979 Transgene foundation 1992 Focuses on gene therapy and therapeutic vaccines 1995 Completion of GMP manufacturing facility 1998 € 87.5 million (Nasdaq and Nouveau Marché) in IPO 2001 € 61.4 million in follow-on HQ in Strasbourg (France) and office near Boston, MA 160 employees as of 3/2
Slide 3: Transgene: Cancer our focus
Transgene Cancer our focus 4 products in clinical trials 4 main assets £ vectors £ target identification £ production £ IP Transgene : a key player in cancer immuno and gene therapy
Slide 4: Multiple Vector Platforms
Multiple Vector Platforms 3 vector families è Ability to select optimal vector for a specific gene and indication Adenovirus Vaccinia Virus Synthetic vectors (MVA) + level and duration of + high + expression immunogenicity + + readministration - readministration - shorter expression -- level of expr
Slide 5: Target Identification
Target Identification Identification and screening of targets/genes from universities and biotechnology companies Agreement with HGS Genomics and proteomics In vitro and in vivo screening models A valuable source for feeding our product portfolio
Slide 6: GMP Manufacturing Facility
GMP Manufacturing Facility GMP manufacturing facility (28,000 square feet) built to Transgene’s specifications in 1995 Designed to handle all production and Q/C steps Meets production needs for Phase I, II and III clinical trials as well as early stage commercialization In-house and subcontracting p
Slide 7: Broad IP Portfolio
Broad IP Portfolio Covers : £ Vectors £ Genes £ Products £ Processes Europe - USA – Japan and other major markets
Slide 8: Clinical Development & Research Portfolio
Clinical Development & Research Portfolio
Slide 9: Cancer Portfolio
Cancer Portfolio Indication Preclinic Phase I Phase II Phase III Cancer vaccines MVA -Muc1-IL2 Lung, Breast, Kidney and Prostate cancers MVA -HPV-IL2 Cervical cancer, VIN, CIN Immune enhancement Ad-IL2 Malignant Melanoma and other solid tumors Ad-IFN γ Cutaneous T Cell Lymphoma Research FCU1 solid t
Slide 10: MVA-MUC1-IL2 Preliminary Clinical Results
MVA-MUC1-IL2 Preliminary Clinical Results Lung cancer : from the first 16 evaluable patients receiving MVA-MUC1-IL2 in association with chemotherapy, positive responses are observed in more than 50 % of the cases. Among them, one patient is stable for 250 days Breast cancer : preliminary data from t
Slide 11: MVA-HPV-IL2 Interim Results
MVA-HPV-IL2 Interim Results Phases II £ Cervix cancer : - Study amended end of stage 1 Combination with chemotherapy £ CIN 2/3 : - Encouraging interim data with viral clearance - Proceed with enrolment both arms ; Study results by year end. £ VIN : recruitment to be completed in June 2003 (5 new cen
Slide 12: Adeno IL2 - Clinical Program
Adeno IL2 - Clinical Program Study design £ Dose escalation £ 5 dose levels 3.10E8 tp → 3.10E11 tp £ 3 patients / cohort Treatment plan £ IT administration £ Every 3 weeks for the first 5 injections then every 6 weeks Results £ 20 patients included £ Well tolerated – IL2 expression Future developmen
Slide 13: Adeno IFNγ Cutaneous T Cell Lymphoma
Adeno IFNγ Prof Dummer Cutaneous T Cell Lymphoma Design £ 3 dose levels 3.10E9 tp - 3.10E10 tp - 3.10E11 tp £ 1 IT injection weekly for 3 weeks Results £ Clinical responses in 7 out of 11 patients £ 6 out of 8 patients (75 %) in the subgroup excluding Sezary Syndrome £ Immunological and histological
Slide 14: Kill the tumor: suicide gene FCU1
Kill the tumor : suicide gene FCU1 5-fluorocytosine 5-fluorocytosine Bystander effect 5-fluorocytosine 5-fluorocytosine Tumor volume of nude mice with LoVo tumors 800 vehicle/water ) +/- sem 600 vehicle/5-FC 0,1% Tumor volume (mm 3 MVA-null/water 400 P53 MVA-null/5-FC 0.1% MVA-FCU1/water 200 MVA-FCU
Slide 15: Business Development Objectives
Business Development Objectives Cancer products Identify partners for the development of our Phase I-II products Targets Identification of targets/technologies in the cancer field Technology platform £ Vectors £ Homologous recombination Manufacturing Subcontracting agreements for the production of p
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