Transgene SA · EURONEXT:TNG
Transgene SA — Investor Presentation (May 2006)
23 slides from Transgene SA's investor presentation, May 2006
Slide 1: Transgene Corporate Presentation May 2006
TRANSGENE Corporate Presentation May 2006 1 transgene
Slide 2: Company Profile
Company Profile 1. An integrated company focused on Therapeutic Vaccines for the treatment of cancer and Infectious Diseases. located in Strasbourg, France - 167 employees Basic Research + cGMP - Manufacturing + Clinical Trials & Regulatory Affairs Preclinical Quality Controls Europe / US 2. Financi
Slide 3: Substantial Pipeline at key turning point
Substantial Pipeline at key turning point Drug Candidate Indication Preclinical Phase I Phase II Phase III New Drug Current Status Application TG 4010 Non-Small Phase II b interim (MVA- MUC1-IL2) Cell results 2007 Lung Cancer TG 4001 Prevention of Phase IIb completed (MVA –HPV-IL2) Cervical Q2 2006
Slide 4: TG 4010 (MVA-MUC1-IL2) in lung cancer
TG 4010 (MVA-MUC1-IL2) in lung cancer § Antigen-specific therapeutic vaccine Market potential derived from recombinant non-replicative § Lung cancer. First line treatment in highly immunogenic Modified Vaccinia combination with chemotherapy. Estimated mortality in EU & US = Ankara (MVA) poxvirus con
Slide 5: TG 4010 Phase IIa Results (ASCO, May 2005) in Non Small Cell Lung Cancer
TG 4010 (MVA-MUC1-IL2) Phase IIa Results (ASCO, May 2005) in Non Small Cell Lung Cancer Clear clinical benefit from the combination therapy as compared to the standard cisplatin/vinorelbine chemotherapy 35 evaluable patients # patients Response rate (%) Partial responses 13/35 37% Stable disease 12/
Slide 6: TG 4010 in NSCLC: controlled Phase IIb protocol
TG 4010 (MVA-MUC1-IL2) in non-small cell lung cancer : controlled Phase IIb protocol § Randomized, open label, multicenter study § Principal Investigator : Professor E. Quoix § 28 centers to be opened in the European Union § Primary objective : to assess the efficacy of TG4010 combined with chemothe
Slide 7: TG 4010 in NSCLC: controlled Phase IIb
TG 4010 (MVA-MUC1-IL2) in NSCLC: controlled Phase IIb § Recruitment expected to be completed by the beginning of Q4 2006 with first interim results due in Q2 2007. § These results will form the basis for partnering discussions for advanced development and commercialization of TG 4010 which are expec
Slide 8: MVA-HPV-IL2: preventing cervical cancer
MVA-HPV-IL2 : preventing cervical cancer § Antigen-specific therapeutic vaccine derived from Potential market recombinant non-replicative highly immunogenic Modified Vaccinia Ankara (MVA) poxvirus containing sequences coding HPV16 E6/E7 antigens and the § Prevention of cervical cancer. cytokine inte
Slide 9: TG4001 (MVA-HPV-IL2): HPV-linked cervical lesions
TG4001 (MVA-HPV-IL2) : HPV-linked cervical lesions Infection Expression of all HPV genes and virus production Chronic Infection Viral DNA Integration in infected cells Cervical Dysplasia (CIN1, 2/3) High risk HPV, E6 & E7 genes Microinvasive cancer Expression Cervical Cancer 9 transgene
Slide 10: Incidence of HPV-linked diseases
Incidence of HPV-linked diseases Linked to Europe/U.S. HPV16 Cervical 80,000 <50% Cancer CIN2/3 900,000 >50% CIN1 2,500,000 >25% Chronic Infection 25,000,000 10 transgene
Slide 11: Prevalency of different HPV genotypes in Europe + USA for CIN 2/3
Prevalency of different HPV genotypes in (Europe + USA) for CIN 2/3 CIN2/3 100 Others HPV16-like 50 average= 80.9% HPV16 average= 0 50.8% 00 0 38 87 02 =5 ,2 =1 =4 ,3 N =1 =4 N N N N Clifford, 2003 Meta-analysis Padilla, 2003 Becker,1994 Schiffman, 1993 Roda Husman, 1994 52% EU, 19% Latin America Al
Slide 12: Therapeutic options
Therapeutic options Disease evolution INFECTION CIN1 CIN2/3 CERVICAL CANCER NO TREATMENT FOLLOW-UP CONE BIOPSY SURGERY LEEP CHEMO-RADIOTHERAPY 12 transgene
Slide 13: CIN2/3 existing therapy: Cone biopsy
CIN2/3 existing therapy : Cone biopsy §Surgical procedure under local or general anesthetic in hospital. § Efficacy of about 90 %. § However complications may arise: §Bleeding in 3.5 - 5% of cases (International Agency for Research on Cancer) §Miscarriage and inability to become pregnant §Recurrence
Slide 14: TG 4001 (MVA-HPV-IL2) Phase II study
TG 4001 (MVA-HPV-IL2) Phase II study § Presented at Eurogin 2006 congress in Paris on April 25, 2006 § 9 clinical centres in France § Open label study design; 3 subcutaneous weekly injections of 5x107 pfu § 21 patients treated, 18 evaluable to date § Age range: 25 to 44 years old, average of 34 year
Slide 15: TG 4001 Phase II results: Objective met!
TG 4001 (MVA-HPV-IL2) Phase II results : “Objective met !” § Results at month 6: ü 9 cone biopsies avoided / 18 ü Normal colposcopy : 10 patients / 18 ü Eradication of CIN 2/3 : 9 patients / 18 ü No more mRNA of E6/E7 : 9 patients / 18 § Very good tolerance. § Open the way for developing a safe and
Slide 16: TG 1042 (Ad-IFNγ) in cutaneous lymphoma
TG 1042 (Ad-IFNγ) in cutaneous lymphoma § Adenoviral vector containing the human Potential market interferon gamma cytokine. § Cutaneous B-Cell Lymphoma. Orphan indication. Prevalence of 10,000-15,000 patients EU/US. Potential market § Immunotherapy product developed cutaneous estimated at about EUR
Slide 17: Ad-IFNγ Phase I/II Results (ASH, December 2005) in cutaneous lymphoma
Ad-IFNγ Phase I/II Results (ASH, December 2005) in cutaneous lymphoma Open-label multicenter, dose-escalation phase I/II trial with 39 patients (31 evaluable) with relapsing primary cutaneous T-cell or B-cell lymphoma. Repeated monthly cycles of 3 intratumoral injections. Complete Partial Total Eval
Slide 18: TG 1042 current status and future direction
TG 1042 (Ad-IFNγ) current status and future direction § IND application with the US FDA to obtain authorization to initiate a Phase II/III study in the US filed in January 2006. § The open label, multicenter, two-step trial will enroll 41 patients with relapsing CBCL following radiotherapy in the US
Slide 19: TG 4040 (MVA-HCV): therapeutic vaccine for hepatitis C chronic carriers
TG 4040 (MVA-HCV): therapeutic vaccine for hepatitis C chronic carriers § 170-200 M people infected worldwide ; 12 M people infected in US, EU and Japan; in France, 500 000 people infected, 50 % diagnosed, 30 % treated with 50% efficacy. § Preclinicals ongoing. § Funding by Lyon BioPôle (€ 1.3 M ove
Slide 20: Myodys
Myodys® § Gene therapy against Duchenne Muscular Dystrophy § Fully financed by the French Association Against Muscular Dystrophy § Phase I/II planned in late 2007 20 transgene
Slide 21: 2006 Milestones
2006 Milestones § Mid-year : Expected initiation of a Phase I/II trial with TG 4040 (MVA-HCV) in the U.S. in chronic hepatitis C patients. § Warrants exercise by July 17, 2006 (max. € 18.5 Million ). § Third quarter : Expected launch of the Phase II/III trial in the U.S. in cutaneous B-cell lymphoma
Slide 22: Today we are well on our way to meet our objectives
Today we are well on our way to meet our objectives. 22 transgene
Slide 23: Contacts Transgene
Contacts Transgene Philippe Archinard, CEO Philippe Poncet, CFO +33 3 88 27 91 00 Transgene 67082 Strasbourg Cedex Web Site: www.transgene.fr 23 transgene