Transgene Sa · EURONEXT:TNG
Transgene Sa — Investor Presentation (September 2017)
42 slides from Transgene Sa's investor presentation, September 2017
Slide 1: Viral-based immunotherapies to transform the fight against cancers and infectious diseases
Viral-based immunotherapies to transform the fight against cancers and infectious diseases September 2017 Corporate presentation
Slide 2: Safe harbour statement
Safe harbour statement This presentation contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that (i) the results of the Phase 2b part of the TIME trial wil
Slide 3: Transgene | Poised to play a key role in immunotherapy
Transgene | Poised to play a key role in immunotherapy A pioneer in developing viral vector-based 2 5 immunotherapies Immunotherapy platforms Immunotherapy products for cancers in clinical trials • Therapeutic vaccines and infectious diseases • Oncolytic viruses o/w 3 at Phase 2 stage Advanced cance
Slide 4: Our combination focused strategy
Our combination focused strategy Demonstrate the power of our current immunotherapies Today by focusing on combination trials with the new standard of care (ICIs) Deliver a new cancer combination paradigm centered Tomorrow on our multifunctional oncolytic viruses 4
Slide 5: Management | Experienced team
Management | Experienced team Philippe Archinard, PhD Chairman & Chief Executive Officer Eric Quéméneur, PhD Executive VP and Chief Scientific Officer E Christophe Ancel, PharmD VP Quality and Qualified Person C Maud Brandely, MD, PhD Chief Medical Officer D Jean-Philippe Del VP Finance A B C D E F
Slide 6: Recent Achievements | Validate Transgene's strategy
Recent Achievements | Validate Transgene’s strategy Refocused clinical development on combi. trials with ICIs • 3 clinical collaboration agreements for TG4010 and TG4001 Exciting clinical • Actively working on 5 combination clinical trials, 4 already recruiting product portfolio 7 active clinical tr
Slide 7: Anti-PD-1/PD-L1 | A new paradigm – need for improvement
Anti-PD-1/PD-L1 | A new paradigm – need for improvement Transgene’s indications of interest 100 Non-responders ORR % 50 0 FDA approved agent available Source: from ASCO Annual meeting 2017, ORR = approximate objective response rate % by Gregory L. Beatty, MD PhD 7
Slide 8: Our strategy | Materialize the value of mature clinical assets & develop disruptive future innovation
Our strategy | Materialize the value of mature clinical assets & develop disruptive future innovation Optimized to deliver Today Combined with ICIs Tomorrow multi functional payloads Transgene’s Immune Checkpoint Engineered viruses that attack the tumor + at multiple points immunotherapies Inhibitor
Slide 9: Diversified portfolio of clinical-stage immunotherapies
Diversified portfolio of clinical-stage immunotherapies Preclinical Clinical Phase Product Indication 1 2 3 THERAPEUTIC VACCINES Non-small cell lung cancer – 2nd line + nivolumab (ICI) TG4010 Non-small cell lung cancer – 1st line + nivolumab (ICI) + CT Non-small cell lung cancer Neo-adjuvant (transl
Slide 10: Therapeutic Vaccines
Therapeutic Vaccines Ideally Suited for Combination Immunotherapy Regimens
Slide 11: Our Therapeutic Vaccines platform
Our Therapeutic Vaccines platform Therapeutic vaccines express tumor/viral antigens to stimulate a safe and specific immune response Vaccination Lymph node Tumor Site (SC injection) (priming site) Therapeutic vaccines have shown important benefits when combined MHC-1 APC Tumor with chemotherapy and/
Slide 12: TG4010 Targeting NSCLC
TG4010 Targeting NSCLC Modified Virus Ankara (MVA) expressing MUC1 antigen & interleukin 2 Supported by
Slide 13: TG4010 | Strong clinical data
TG4010 | Strong clinical data Well positioned for further development in NSCLC SUCCESSFUL PHASE 2B TRIAL (RANDOMIZED, PLACEBO-CONTROLLED, 222 PATIENTS) TG4010 in combination with chemotherapy for 1st line NSCLC Progression-free survival (months) Overall survival (months) ✓ Significant improvements i
Slide 14: TG4010 | Strong clinical data
TG4010 | Strong clinical data Improved response rate & duration of response TG4010 Placebo Non-squamous (n) 98 98 ORR 40% 28% Median duration of response (wks) 41 18 ✓ Improved response rate & duration of response ✓ Good safety profile Source: The Lancet Oncology, Dec. 2015, Quoix, E. et al. 14
Slide 15: TG4010 | Clinical positioning
TG4010 | Clinical positioning A very large population in NSCLC, stage IV, non-squamous patients Eligible Population (US, EU, JP), in thousands of patients STAGE IV 710 K NON-SQUAMOUS 532 K NON-MUTATED (ALK, EGFR, …) 441 K 1L - TG4010 LOW PD-L1 - 1ST LINE 331 K positioning 2L - TG4010 2ND LINE (INDEP
Slide 16: TG4010 | Combination with ICIs
TG4010 | Combination with ICIs Scientific Rationale TG4010 Immune Checkpoints Inhibitors (Therapeutic vaccine) (ICIs) Demonstrated mechanism of action: Block the signal that prevents induction of CD8+ T cell response activated T-cells from attacking cancer cells Activity shown in patients with no/lo
Slide 17: TG4010 | Clinical development plan (non sq. NSCLC)
TG4010 | Clinical development plan (non sq. NSCLC) Generate additional data in combination with ICIs 3 trials to position TG4010 in all settings of advanced NSCLC Initiate two Phase 2 trials in combination with PD-1 inhibitor and a translational study to further document MoA NSCLC - 1st line TG4010
Slide 18: TG4010 | NSCLC - 2nd line
TG4010 | Non-Small Cell Lung Cancer (NSCLC) - 2nd line Phase 2 in combination with Opdivo® (Nivolumab) Protocol Support of • Up to 33 patients • Multi-center, single-arm, open label study • Stage IV non-squamous NSCLC who have progressed after one line of systemic therapy Endpoints • Principal Inves
Slide 19: TG4010 | NSCLC - 1st line
TG4010 | Non-Small Cell Lung Cancer (NSCLC) - 1st line Phase 1/2 in combination with Opdivo® + Chemotherapy (CT) Support of Protocol • Up to 39 patients • Multi-center, single-arm, open label study • Stage III B-IV or delayed relapse, tumors with low or undetectable PD-L1 expression • Collaborative
Slide 20: TG4001 targeting HPV-positive head and neck cancer
TG4001 targeting HPV-positive head and neck cancer MVA expressing HPV16 E6 & E7 antigens & interleukin 2 Supported by
Slide 21: TG4001 | Current treatments for recurrent/metastatic HNSCC
TG4001 | Current treatments for recurrent/metastatic HNSCC First-line therapy Dismal prognosis • For patients with good performance status: historically platinum- based doublet Better therapeutic options (eg. Cisplatin/5-FU or carboplatin/paclitaxel) needed – ORR: 30% to 40%; median OS: 6-9 months r
Slide 22: TG4001 | HPV-positive Head & Neck Cancers (HNSCC)
TG4001 | HPV-positive Head & Neck Cancers (HNSCC) Phase 1/2 in combination with avelumab (Bavencio®) Support of Protocol • Up to 50 patients (France) • Multi-center, single-arm, open label trial • Metastatic or refractory/recurrent HPV-16+ head & neck cancers, after failure of standard therapy Colla
Slide 23: TG1050 targeting chronic hepatitis B
TG1050 targeting chronic hepatitis B Modified Adenovirus 5 that expresses 3 different HBV (Hepatitis B Virus) antigens
Slide 24: TG1050 | Phase 1/1b in HBV patients close to completion
TG1050 | Phase 1/1b in HBV patients close to completion Combination with standard antivirals Only ~3% of patients treated Large unmet medical need: cure rate is extremely low with antivirals are cured Chronic HBV Need to improve clinical outcome High risk of developing cirrhosis • ~500,000 eligible
Slide 25: Oncolytic Viruses
Oncolytic Viruses A New Promising Therapeutic Class
Slide 26: Our Oncolytic Virus platform
Our Oncolytic Virus platform • Act by directly attacking tumor cells Next generation of cancer immunotherapies • And by stimulating immune response IT / IV administration Oncolytic viruses T cell Infiltrated T cell 3 (CD8+) (OV) selectively oVV cause cell lysis in 1 the primary tumor 4 and boost the
Slide 27: Pexa-Vec in hepatocellular carcinoma (HCC)
Pexa-Vec in hepatocellular carcinoma (HCC) Vaccinia Virus expressing GM-CSF
Slide 28: Pexa-Vec | complementary mechanisms of action
Pexa-Vec | 3 complementary mechanisms of action 3 1.Cancer cell oncolysis (Kirn D 2009): Infection, cell lysis and viral spread 1 2.Tumor vascular shutdown (Breitbach C 2013): Infection and cell lysis 3.Active immunotherapy (Kim MK, 2013): Tumor- 2 specific immune response stimulation (GM-CSF) Kirn
Slide 29: Pexa-Vec | Large unmet medical need in HCC
Pexa-Vec | Large unmet medical need in HCC First-line therapy • Sorafenib is currently the only approved product - modest Dismal prognosis activity – ORR: 2% ; median OS: 10.7 months Better therapeutic options needed • Nivolumab likely to become a new therapeutic option: Promising activity in Phase
Slide 30: Pexa-Vec | Clinical development plan
Pexa-Vec | Clinical development plan Pivotal Phase 3 and three complementary studies 1. Complete the Phase 3 Trial in 1st Line HCC in Combination with Sorafenib • Multi-center Phase 3 trial in Europe, US, Asia Advanced HCC Pexa-Vec • Randomized, two arm trial 1st line + sorafenib • Ongoing recruitme
Slide 31: Pexa-Vec | Ongoing Phase 3 clinical trial (PHOCUS trial)
Pexa-Vec | Ongoing Phase 3 clinical trial (PHOCUS trial) 1st line advanced hepatocellular carcinoma Phase 3 study in combination with sorafenib (Kinase inhibitor) • Pexa-Vec + sorafenib versus sorafenib (only approved drug for advanced HCC) Conducted by Design • N=600 patients (Europe, North America
Slide 32: Engineering oncolytic viruses
Engineering oncolytic viruses Creating next generation of immunotherapies
Slide 33: Oncolytic viruses | Transgene's roadmap for success
Oncolytic viruses | Transgene’s roadmap for success FUTURE GENERATIONS Innovative content NEW GENERATION • Oncolytic activity • Systemic (IV) administration • Better tumor selectivity Imlygic/T-Vec, Pexa-Vec • Oncolytic activity (double gene deletion) • Systemic (IV) administration • “Armed” – targe
Slide 34: TG6002 | First product from our new generation platform
TG6002 | First product from our new generation platform Improved backbone and advanced therapeutic payload Superior oncolytic properties with local production of chemotherapy Viral oncolysis • Proprietary backbone FCU1 gene Cell • Double gene deletion TK- RR- Targeted Prodrug activating Cytotoxic dr
Slide 35: Immuno-armed oncolytic strategy
Immuno-armed oncolytic strategy A multifunctional design Validated Differentiating Additional 1 backbone 2 Targets 3 Targets Cytokines / Chemokines Enzyme VV TK- RR- + + 2nd antibody Antibody Receptor ligands Oncolytic activity Key effectors of the tumor Complementary effectors of the Immunogenic pr
Slide 36: Research collaboration with Servier
Research collaboration with Servier Development of a novel method for allogenic CAR-T preparation Application of viral vectors technology • Large collection of viral vectors for to the engineering of allogenic CAR-T therapeutic applications • Competence in genome engineering Objectives • Evaluate an
Slide 37: Outlook
Outlook On Track to Deliver Multiple Value-Enhancing Clinical Data Read-Outs
Slide 38: Significant news flow in the next 12-18 months
Significant news flow in the next 12-18 months TG4010 Lung cancer (NSCLC) TG4001 HPV+ head & neck cancer (HNSCC) 5 clinical stage TG1050 Chronic hepatitis B (HBV) products Pexa-Vec Liver cancer (HCC) TG6002 Glioblastoma & gastro-intestinal tumors 38
Slide 39: 2017 - A year of significant progress
2017 - A year of significant progress 1st line: • Collaboration agreement • US FDA IND Approval TG4010 • 1st patient of the Phase 2 trial 2nd line: • 1st patient treated TG4001 First patient treated (H2 2017) TG1050 First results (H2 2017) Phase 3, HCC, 1st line: 1st patient treated in Europe (Q2 20
Slide 40: Appendices
See immunotherapeutics Appendices 40
Slide 41: Transgene Ownership
Transgene Ownership Key Shareholders As of June 30, 2017 • 56.4 million shares outstanding + 1.1 million options and free shares • Market capitalization: ~ €200 million as of September 12, 2017 60 % Free float • Listed on Euronext Paris 40 % • ISIN: FR0005175080 • Ticker: TNG 41
Slide 42: Contact
Contact Lucie Larguier Director Corporate Communication and Investor Relations +33 3 88 27 91 04 / +33 6 76 24 72 27 [email protected] / [email protected] @TransgeneSA Transgene 400 Boulevard Gonthier d’Andernach - Parc d’Innovation - CS80166 67405 Illkirch Graffenstaden Cedex Franc