Transgene Sa · EURONEXT:TNG
Transgene Sa — Investor Presentation (July 2020)
30 slides from Transgene Sa's investor presentation, Jul 22, 2020
Slide 1: Immunotherapies against cancer
Immunotherapies against cancer 22 July 2020 Corporate presentation
Slide 2: Disclaimer
Disclaimer 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 pre-clinical work and prior clinical trials will be
Slide 3: Transgene | Company overview
Transgene |Company overview Virus-based • 150 employees immunotherapies • Listed on the Paris stock exchange against solid tumors • Clinical trials active in Europe and in the US Strasbourg (HQ) • Integrated R&D manufacturing unit (GMP) • 200 registered patents, 100 pending patents • Collaborations
Slide 4: Transgene | Virus-based immunotherapeutics
Transgene | Virus-based immunotherapeutics 4 clinical-stage products and 2 novel platforms Therapeutic Vaccines Oncolytic Viruses ✓ Large transgene capabilities ✓ Good safety profile ✓ Stimulate innate and adaptive immune response HPV16 Individualized Chemotherapy Multifunctional therapeutic vaccine
Slide 5: Strong R&D and clinical activity
Strong R&D and clinical activity # trials Promising clinical activity reported in exploratory Phase 1b/2 TG4001 trial in advanced HPV16-positive cancers 1 Clinical Results TG6002 IV route - Last dose levels currently evaluated IHA route - First patient dosed in Feb. 2020 2 Two clinical trials with T
Slide 6: Objectives for the coming months
Objectives for the coming 12 months Portfolio to deliver significant news flow 3Q 2020 • TG6002 CRC - IV route: First Phase 1 clinical readout • TG4001: Finalize protocol with KOLs to continue clinical development in a larger, controlled confirmatory study • BT-001: First clinical trial approval and
Slide 7: Exploratory Phase 1b/2 trial with TG4001 and ICI demonstrates clinical activity
Exploratory Phase 1b/2 trial with TG4001 and ICI demonstrates clinical activity in HPV16-positive, recurrent metastatic cancer patients, having progressed after up to three lines of chemotherapy 7
Slide 8: Better options needed for HPV16-associated cancer patients
Better options needed for HPV16-associated cancer patients whose disease has progressed after at least one line of chemotherapy KN040(1) N = 495 (1:1) CM141(2) N = 361 (2:1) Nivolumab(3) KN028 and KN158(5) NCI9673 KN158(4) Phase 3 Phase 3 Phase 2 Phase 2 Head and neck Head and neck Anal Pooled analy
Slide 9: TG4001 | Therapeutic vaccine targeting HPV-positive cancers
TG4001 | Therapeutic vaccine targeting HPV-positive cancers Optimized virus Transgenes SC injection • HPV16 E6&7 antigens • Attenuated MVA • Human IL2 Designed to boost the patient’s immune system against the tumor ❶ Targeted response against tumor cells carrying the HPV16 E6 & E7 antigens* ❷ Stim
Slide 10: TG4001 | Phase 1b/2 in combination with Avelumab in HPV+ cancers
TG4001 | Phase 1b/2 in combination with Avelumab in HPV+ cancers In collaboration with Principal Investigator • Pr Christophe Le Tourneau, Institut Curie Key Eligibility Criteria • Histologically or cytologically documented metastatic / recurrent HPV16+ cancer (central) • At least one prior line of
Slide 11: Promising clinical activity reported in pooled analysis of the Phase 1b/2 data
Promising clinical activity reported in pooled analysis of the Phase 1b/2 data Selection criterion identified Clinical activity in overall population • Population with particularly pronounced activity (34 evaluable patients) • At 12 weeks, +50% of these patients had not progressed – while with curre
Slide 12: Creating individualized immunotherapies based on our molecular virology expertise
► Creating individualized immunotherapies based on our molecular virology expertise ► First product TG4050 in two ongoing clinical trials 12
Slide 13: TG4050 | Individualized immunotherapy already in the clinic
TG4050 | Individualized immunotherapy already in the clinic Targets the patient’s own neoantigens MVA-based immunotherapy • MVA vector: safe and immunogenic - Expected to induce broader and stronger T cell response - Prime/boost patient’s immune system to overcome the immunosuppressive environment
Slide 14: TG4050 | Process for individualized neoantigen vaccination
TG4050 | Process for individualized neoantigen vaccination Combines bioengineering and digital transformation Routine Data processing, Gene editing, tumor biopsy Gene sequencing Artificial intelligence Manufacturing Next generation Selection Vaccine generation Patient sequencing of 30 neoantigens
Slide 15: Remarkable specificity of our AI approach compared to the industry standard
Remarkable specificity of our AI approach compared to the industry standard 1 to 5% of tumor mutations are immunogenic - particularly difficult to identify Our neoantigen prediction tool was run on highly mutated tumors, thus generating a massive amount of mutations to analyze • 86+% of top ranked
Slide 16: TG4050 | Proof-of-concept Phase 1 ongoing (ovarian cancer)
TG4050 | Proof-of-concept Phase 1 ongoing Ovarian cancer after surgery Lead investigator: and adjuvant chemotherapy Matthew S. Block, MD, PhD Mayo Clinic (Rochester) Study • Single arm, open label Phase 1 trial (NCT: 03839524) • Sites in the USA and in France • 13 patients Protocol • Patients receiv
Slide 17: TG4050 | Proof-of-concept Phase 1 ongoing (head and neck)
TG4050 | Proof-of-concept Phase 1 ongoing HPV negative head and neck This trial builds upon a long-term research collaboration between cancers Transgene and the University of Southampton. I believe such perso- after surgery and adjuvant therapy nalized vaccine approaches are the next paradigm in can
Slide 18: Our next generation multifunctional oncolytic virus (OV) platform
Our next generation multifunctional oncolytic virus (OV) platform TG6002 18
Slide 19: Invir.IO | Optimized OVs attack tumor on multiple fronts
Invir.IO™| Optimized OVs (VVCop TK-RR-) tumor attacked on multiple fronts Superior oncolysis ✓ Direct lysis of infected cells ✓ More specific replication in tumor cells Delaunnay et al., 2018 Increased and durable immune response ✓ Induction of immunogenic cell death ✓ Engagement of innate and adapt
Slide 20: TG6002 | First multifunctional OV in the clinic
TG6002 | First multifunctional OV in the clinic Expected increased efficacy without CT-associated side effects ❶ Excellent oncolytic properties ❷ Production of chemotherapy (5-FU) in the tumor with FCU1 gene Optimized virus Chinese rights sold • Optimized and patented VVCop TK-RR- OV to Tasly Biop
Slide 21: TG6002 | Two Phase 1/2a trials in 5-FU sensitive GI indications
TG6002 | Two Phase 1/2a trials in 5-FU sensitive GI indications Two novel administration routes - IV and IHA Gastro-intestinal adenocarcinoma with liver Colorectal cancer patients with unresectable metastasis (colon cancer) - IV route liver metastases (CRLM) – IHA route Protocol Protocol • Phase 1
Slide 22: Collaboration and license option agreement with AstraZeneca
Collaboration and license option agreement with AstraZeneca Invir.IO™ platform validation 5 novel oncolytic immunotherapies will be Conduct of the project: developed, integrating: • Transgene designs the OVs and conduct • Transgene Invir.IO™ based oncolytic viruses in vitro preclinical development
Slide 23: BT-001 expresses GM-CSF and anti-CTLA4 mAb
B T-001 | BT-001 expresses GM-CSF and anti-CTLA4 mAb BT-001 Outstanding preclinical data Strong antitumor activity in several • Collaboration with BioInvent : Transgene’s immunocompetent mice models Invir.IO™ OV + BioInvent’s full length human Higher concentration and prolonged activity of recom
Slide 24: BT-001 | Outstanding preclinical data
B T-001 | Outstanding preclinical data for BT-001 mBT-001 has strong anti-tumoral activity mBT-001 (1 % of full dose) increases (70+% cure rate) activity of anti-PD1 mAb Source: Marchand et al., “BT-001, an oncolytic Vaccinia virus armed with a Treg-depletion-optimized recombinant human anti-CTLA4 a
Slide 25: Outlook
Outlook Strong clinical activity in 2020
Slide 26: Current pipeline
Current pipeline Partner Preclinical Clinical Phase Product Indication Phase 1 Phase 2 Next step THERAPEUTIC VACCINES * Finalize protocol for TG4001 Reccurent HPV positive cancer + avelumab (ICI) next clinical trial Ovarian cancer * 1st trials readouts TG4050 in 1H 2021 Head & neck cancers ONCOLYTIC
Slide 27: Our priorities for 2020/2021
Our priorities for 2020/2021 TG4001 • Finalize protocol to continue clinical development in a larger, controlled confirmatory study • Present data at scientific conference TG6002 • Progress our clinical development to deliver readout • Start clinical trial on BT-001 in 2H 2020 • Select second clinic
Slide 28: Appendix
See immunotherapeutics Appendix 28
Slide 29: Promising efficacy data from Phase 1b presented at ESMO 2019
Promising efficacy data from Phase 1b - presented @ESMO 2019 RECIST 1.1 evaluation: Hard-to-treat population: Partial response: 3 • 1 to 3 prior systemic chemo lines - 100% with distant metastases Stable disease: 3 Best change in tumor size Individual patient data % Change from baseline % Change fro
Slide 30: Contact
Contact Lucie Larguier Director Corporate Communication and Investor Relations +33 3 88 27 91 04 / +33 6 76 24 72 27 larguier@transgene.fr / investorrelations@transgene.fr @TransgeneSA Transgene 400 Boulevard Gonthier d’Andernach - Parc d’Innovation - CS80166 67405 Illkirch Graffenstaden Cedex Franc