Transgene Sa · EURONEXT:TNG
Transgene Sa — J.P. Morgan Healthcare Conference 2023
48 slides from Transgene Sa's conference presentation, January 2023
Slide 1: Virus Powered Immunotherapies against Solid Tumors
Virus Powered Immunotherapies against Solid Tumors Corporate Presentation January 2023
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: An Experienced Management Team
An Experienced Management Team Click to edit Master title style ÉRIC QUÉMÉNEUR, PHD HEDI BEN BRAHIM Executive VP Chief Executive Officer Chief Scientific Officer 20 YEARS EXPERIENCE 30+ YEARS EXPERIENCE ALESSANDRO RIVA Chairman Joined in May 2022 30+ YEARS EXPERIENCE MAUD BRANDELY, MD, STEVEN BLOOM
Slide 4: Transgene – Frontline Player in Virus-Based Immunotherapy Against Cancer
Transgene – Frontline Player in Virus-Based Immunotherapy Against Cancer Versatile technology Click to edit Master title style platforms to fit each patient need 2 platforms 4 clinical-stage Dense news flow Diversified pipeline Therapeutic vaccines immunotherapies in 2023-2024 (individualized and of
Slide 5: Our Expertise Translates into Two Unique Technology Platforms
Our Expertise Translates into Two Unique Technology Platforms Virus Click to based platforms edit Master title style with unique track record of clinical experience and MoA data 1 THERAPEUTIC VACCINES Transgene’s Viral 1. Select the right antigens: Patient specific antigens selected to vectors gener
Slide 6: A Comprehensive Immunotherapy Portfolio Designed to Fit Patients’ Needs
A Comprehensive Immunotherapy Portfolio Designed to Fit Patients’ Needs From Click to antigen edit Master agnostic title style to tumor specific antigens, and from off-the-shelf to patient tailored Product Target/transgene Indication Collaboration Preclinical Phase I Phase II Next step THERAPEUTIC V
Slide 7: TG4001: Potential to Transform the Treatment of Anogenital HPV Positive Solid Tumors
TG4001 Potential to Transform the Treatment of Anogenital HPV Positive Solid Tumors Ongoing randomized Ph. II in combination with checkpoint blocker
Slide 8: TG4001 | Optimized Treatment Designed for HPV-Positive Tumors
TG4001 | Optimized Treatment Designed for HPV-Positive Tumors Potential to Address Click to edit Master title style All HPV Positive Cancers Ongoing Phase II trial MVA virus Anogenital HPV16-positive cancers E6 and E7 HPV antigens without liver metastasis Designed to induce 25,000 new pts/year[1] sp
Slide 9: TG4001 + Avelumab | Increased Benefit in Large Patient Subset
TG4001 + Avelumab (Single Arm Ph. Ib/II) | Increased Benefit in Large Patient Subset Promising results, Click to edit Master particularly in patients without liver metastasis title style Compares favorably to ICIs in monotherapy Metastatic patients and competitive landscape w/o liver metastasis (n=2
Slide 10: TG4001 + Avelumab | Treatment Induced Long-Lasting Responses
TG4001 + Avelumab (Single Arm Ph. Ib/II) | Treatment Induced Long-Lasting Responses Click to edit Master title style Change in tumor size – End of Aug. 2022 in metastatic patients without liver metastases 1 patient still treated after 4+ years 2 patients with 2+ years follow up Responses were also o
Slide 11: TG4001 | Randomized Controlled Phase II Trial Backed by Multiple Clinicians
TG4001 | Randomized Controlled Phase II Trial Backed by Multiple Clinicians Trial to Enroll up to ~ 120 Patients (NCT03260023) Patients with HPV16-positive anogenital cancer incl. cervical, vulvar, vaginal, penile and anal cancers With recurrent/metastatic disease Treated in 1st line or in 2nd line
Slide 12: Our Objective: Boost Response to Immune Checkpoint Inhibitors in HPV+ Cancers
Our Objective: Boost Response to Immune Checkpoint Inhibitors in HPV+ Cancers Click to edit Master title style Increased Induces Active in PD-L1 Response Rate Good safety antigen-specific Induces broad Long-lasting positive and and PFS in profile immune T cell response responses negative hard-to-tre
Slide 13: Individualized Neoantigen Vaccine
Individualized Neoantigen Vaccine Taking the Treatment of Each Patient’s Tumor to a New Level Initial positive data from the two Phase I trials one patient • one genome • one vaccine
Slide 14: Medical Needs and Current Gaps – Moving Therapeutic Vaccines Up Treatment Lines
Medical Needs and Current Gaps – Moving Therapeutic Vaccines Up Treatment Lines Click to edit Master title style Surgery + First-line of advanced disease Adjuvant therapy therapy and beyond Strong NEED TO INCREASE and EXTEND REMISSION Remission / periods Minimal residual disease Ideal opportunity fo
Slide 15: TG4050 - First Individualized Vaccine Based on the myvac Technology
TG4050 - First Individualized Vaccine Based on the myvac® Technology 2Click ongoing clinical to edit Master trials title style TWO TRIALS DESIGNED TO PROVIDE FIRST EFFICACY DATA AND SUPERIOR IMMUNOGENICITY TG4050 monotherapy could address variety of solid tumors Moderately mutated tumors in patients
Slide 16: TG4050 | An Individualized Neoantigen Vaccine Combining Unique Capabilities
TG4050 | An Individualized Neoantigen Vaccine Combining Unique Capabilities Combines Bioengineering Click to edit Master title style and Digital Transformation 50% Click to play of development costs covered by NEC DATA PROCESSING, ARTIFICIAL INTELLIGENCE GENE EDITING MUTANOME & Selection of 30 Vacci
Slide 17: TG4050 | HPV-Negative Head and Neck Cancer Trial
TG4050 | HPV-Negative Head and Neck Cancer Trial after Surgery and Adjuvant Therapy Click to edit Master title style TG4050 is designed to Arm A INCREASE and EXTEND REMISSION period TG4050 TG4050 + SOC (single agent) (incl. checkpoint Randomized Repeated injections blockers) Phase I Trial Recurrence
Slide 18: Head & Neck Cancer Trial: Extremely Promising First Signals of Clinical Activity
Extremely Promising First Signals of Clinical Activity Repeated Injections Click to edit Master title styleof single agent TG4050 in patients with minimal residual disease Head & Neck Cancer Trial No related SAEs 20 patients randomized - At end of August 2022 Good safety profile 6 months 12 months 1
Slide 19: Unprecedented Rate of T Cell Response Against Tumor Specific Epitopes
Unprecedented Rate of T Cell Response Against Tumor Specific Epitopes Profound Remodeling Click to edit Master title style of Immune Cells Consistent with Anti Tumor Response Priming of innate immunity Immune differentiation during response to immunotherapies Differentiation of CD4 and CD8 Naïve Eff
Slide 20: TG4050 | Exciting First Data Serve Ambitious Development Plan
TG4050 | Exciting First Data Serve Ambitious Development Plan Click to edit Master title style one patient • one genome • one vaccine First signs Induces Potential to of clinical neoantigen- Induces Good safety extend remission activity specific broad T cell profile period and lower in high-risk imm
Slide 21: Our Unique Invir.IO Platform
Our Unique Invir.IO™ Platform Rapidly Generating Multiple Virus-Powered Off-the-Shelf Drug Candidates
Slide 22: Invir.IO Oncolytic Viruses Are Designed to Address Most Cancer Indications
Invir.IO™ Oncolytic Viruses Are Designed to Address Most Cancer Indications Competitive Advantage of the Patented Backbone VVcopTK-RR- from Invir.IO™ Platform Safety and Selectivity Tumor eradication including metastases Multiple modes of action Patented TK-RR- deletion for enhanced tumor selectivit
Slide 23: Transgene & AstraZeneca to Co-Develop Novel Invir.IO OVs
Transgene & AstraZeneca to Co-Develop 5 Novel Invir.IO™ OVs Click to edit Master title style Transgene and AstraZeneca entered into a collaboration and exclusive license option agreement in 2019 For 5 innovative Invir.IO™ based armed oncolytic immunotherapies Integrating one or more transgene(s) cho
Slide 24: BT-001 | Patented OV Armed with Anti-CTLA4 Ab + GM-CSF
BT-001 | Patented OV Armed with Anti-CTLA4 Ab + GM-CSF 50/50 collaboration with BioInvent Ongoing Click to edit Phase I Trial Master title style Assessing IT* Route of Administration The right virus + payload Positive initial Phase I part A VVcopTK-RR- oncolytic armed with readout BioInvent’s potent
Slide 25: TG6050 administered IV | IL-12 and anti-CTLA4 Produced Directly in the Tumor
TG6050 administered IV | IL-12 and anti-CTLA4 Produced Directly in the Tumor Approved Phase Click to edit Master titleIstyle Trial to assess systemic route of administration Oncolytic armed with Indication: metastatic IL-12 and anti-CTLA4 Ab and PD1 failed tumors · Triggers a powerful antitumor Adva
Slide 26: IV Route | Exciting Phase I Data Presented at ESMO 2022
IV Route | Exciting Phase I Data Presented at ESMO 2022 Clinical PoC Click to edit of title Master Feasibility of IV Route for our Patented VVcop TK-RR- Virus (TG6002) thestyle TG6002 replicates in tumor 5-FU is expressed in tumor Long-lasting expression tissue without sign of tissue in most of the
Slide 27: Invir.IO Pipeline Will Allow us to Generate Significant Value
Invir.IO™ Pipeline Will Allow us to Generate Significant Value Next Click toCandidates edit Master title are style Already in Preclinical Development Value provider and collaboration High speed initiator from design Backbone with to clinics AstraZeneca collaboration: development of new OVs demonstra
Slide 28: Outlook
Outlook transgene
Slide 29: Company Funded to Deliver Multiple Value Generating Milestones
Company Funded to Deliver Multiple Value Generating Milestones Ownership €36.3 million in cash and cash equivalents As of December 31, 2022 as of September 30, 2022 In addition: Tasly BioPharmaceuticals shares valued at €19.6 million at the end of June 2022 60% Free float 40% • Listed on Euronext Pa
Slide 30: Dense News Flow in next 18-24 months
Dense News Flow in next 18-24 months AClick to editLeader World Master title style in Virus-Powered Immunotherapies against Solid Tumors TG4001 TG4050 H1 2024 | Last patient randomized in H1 2023 | Additional Phase I data Phase II to be presented H2 2023 | Phase II expected to start ➔ Launch registr
Slide 31: Appendices
Ccpamecrane Appendices
Slide 32: How Virus Powered Vaccines Treat Solid Tumors
How Virus Powered Vaccines Treat Solid Tumors Our vaccines Click to edit Masterinduce title style specific and strong immune response Local transgene Tumor cell killing expression and antigen processing CD8 Immune cell infiltration Cytotoxic activity of CD8 T cell Antigen spreading Danger signals An
Slide 33: Invir.IO Products Display Multiple Modes of Action in the Tumor Micro-Environment
Invir.IO™ Products Display Multiple Modes of Action in the Tumor Micro-Environment Armed oncolytics Click to edit designed to improve the treatment of primary and secondary tumors Master title style Tumor cell breakdown Immune system ignition Local delivery of therapeutic APC CD4 Payload VV expressi
Slide 34: Appendices: TG4001
Ccpamecrane Appendices TG4001
Slide 35: HPV is Associated with a Broad Variety of Anogenital Cancers
HPV is Associated with a Broad Variety of Anogenital Cancers Click to edit Master title style Incidence of anogenital HPV16 positive cancers % of HPV induced cancers by localization w/o liver metastases Newly diagnosed patients with metastatic disease and patients with recurrent disease 70% Orophary
Slide 36: Increasing Role of Immunotherapy in Standards of Care
Increasing Role of Immunotherapy in Standards of Care In first Click and to edit second Master lines of treatment title style CERVIX ANAL VULVAR / VAGINAL PENILE 1L: 1L: 1L: 1L: platinum-based platinum-based platinum single agent, platinum-based chemotherapy +/- chemotherapies platinum-based chemoth
Slide 37: TG4001 - Anogenital Cancer Patients Undergoing 2nd Line Treatment Still Have Poor Prognosis
TG4001 - Anogenital Cancer Patients Undergoing 2nd Line Treatment Still Have Poor Prognosis Overview of clinical nd Click to edit Master title styletrials in anogenital cancers – 2 line of care H&N+ Anogenital Anal Cancer Cervical, Vaginal and Vulvar Cancers Cervical Therapy TG4001 Nivolumab Pembrol
Slide 38: TG4001 Competitive Landscape - Off the Shelf HPV16 Cancer Treatment
TG4001 Competitive Landscape - Off the Shelf HPV16 Cancer Treatment Overview of key Click to edit Master titlemodalities style approved and in development to treat HPV+ Cancers In Development Approved Checkpoint Checkpoint Cancer Vaccines Inhibitor Inhibitor Viral vectors mRNA Peptide DNA Antibody A
Slide 39: Appendices: TG4050
Ccpamecrane Appendices TG4050
Slide 40: TG4050 | Ovarian Cancer Trial after Surgery and Adjuvant Chemotherapy
TG4050 | Ovarian Cancer Trial after Surgery and Adjuvant Chemotherapy Phase I Trial Click to edit intitle Master upstyle to 13 Patients (NCT03839524) TG4050 is designed to Complete response INCREASE and EXTEND Approx. 80% of patients REMISSION periods experience CR Asymptomatic relapse with 12-month
Slide 41: First Patient Treated with TG4050 in Ovarian Cancer Trial
First Patient Treated with TG4050 in Ovarian Cancer Trial Normalization Click to edit Masteroftitle CA-125 style and ctDNA without Clinical Progression for 9 Months 73-year-old female Relevant medical history and treatments Delord et al, “Phase 1 studies of personalized neoantigen vaccine TG4050 in
Slide 42: Extremely Promising First Signals of Clinical Activity
Extremely Promising First Signals of Clinical Activity From Click to Repeated Injections edit Master title style of TG4050 as Monotherapy in Patients with Minimal Residual Disease Ovarian Cancer Trial Data updated end of August 2022 Expected time of clinical progression[1] 6 months 12 months One pat
Slide 43: ctDNA changes are Consistent with Changes in CA-125 and Clinical Outcome
ctDNA changes are Consistent with Changes in CA-125 and Clinical Outcome Click to edit Master title style Patient 1 Patient 2 ctDNA Tumor molecule/mL of plasma ctDNA Tumor molecule/mL of plasma 2.0 400 4 400 CA-125 CA-125 1.5 300 3 300 CA-125 CA-125 (U/mL) (U/mL) ctDNA ctDNA 1.0 200 2 200 0.5 100 1
Slide 44: TG4050 has a Unique Positioning among Personalized Cancer Vaccines
TG4050 has a Unique Positioning among Personalized Cancer Vaccines Click to edit Master title style TG4050 Company Areas of differentiation Technology Modified Vaccinia Ankara (MVA) mRNA DNA self replicating RNA virus (+adenoviral vectors) # targets Up to 30 20 20 20 Simple drug delivery method: SC
Slide 45: Appendices: Invir.IO
Ccpamecrane Appendices invir®
Slide 46: Invir.IO Pipeline in the Clinic
Invir.IO™ Pipeline in the Clinic TG6002 BT-001 TG6050 Payload FCU1 anti-CTLA4 Ab + GM-CSF IL-12 + anti-CTLA4 Ab « Cold » and metastatic tumors Intended indications 5-FU sensitive tumors T reg infiltrated tumors (NSCLC) after PD1/PDL1 treatment failure Route of administration IV IT IV Ability to expr
Slide 47: Overview of Oncolytic Viruses in Clinical Development
Overview of Oncolytic Viruses in Clinical Development OV Platform Click to edit Master title style Company Areas of Differentiation Technology Poxvirus, Vaccinia Virus /Strain Copenhagen strain Best-in-class virus engineering capabilities Chimeric vaccinia (pox)virus HSV1 SKV Vaccinia Adenovirus Pat
Slide 48: Contact
C O N TA C T Lucie Larguier Director Investor Relations and Corporate Communication +33 6 7624 7227 larguier@transgene.fr 400 Boulevard Gonthier d’Andernach | Parc d’Innovation | CS80166 67405 Illkirch Graffenstaden Cedex | France Tél.: + 33 (0)3 88 27 91 21 | www.transgene.fr