Transgene Sa · EURONEXT:TNG

Transgene Sa — World Congress on Infectious Diseases 2026

30 slides from Transgene Sa's conference presentation, Jun 25, 2026

  1. Slide 1: Robust Protection Against Monkeypox Virus Mediated By a Novel Cell-Line-Derived MVA Vaccine (TG-MVACL)

    Robust Protection Against Monkeypox Virus Mediated By a Novel Cell-Line-Derived MVA Vaccine (TG-MVACL) Nathalie Silvestre, Head of the Vectorology Laboratory at Transgene World Congress on Infectious Diseases 25 June 2026 1

  2. Slide 2: Disclaimer

    Disclaimer Data presented herein reflect preclinical analyses available as of the date of this presentation. These results are preliminary and intended for scientific discussion only. They are not predictive of future outcomes and should not be construed as a guarantee of the results, safety, or eff

  3. Slide 3: Outline

    OUTLINE • Background • TG-MVA : a proposed third generation vaccine for mpox and smallpox produced on cell line • TG-MVA : immunogenicity and efficacy in animal models 3

  4. Slide 4: Monkeypox Virus (MPXV)

    Monkeypox Virus (MPXV) An orthopoxvirus belonging to the same family as the Variola virus causing smallpox • General features • Large complex enveloped virions (360 x 250 x 200 nm) belonging to the Poxviridae family • Member of the orthopoxvirus genus, which includes vaccinia virus (VACV) and variol

  5. Slide 5: Monkeypox (mpox): a New Threat

    Monkeypox (mpox) : a New Threat Increase of global burden since 2022 Before 2022 • Mpox was an emerging disease circulating in limited regions in Africa with sporadic cases out of the continent • May: Outbreak caused by Clade IIb in Africa and in non endemic country (UK) and fast spread to EU and US

  6. Slide 6: Orthopox-Related Diseases: a Global Threat

    Orthopox-Related Diseases : a Global Threat • Mpox: a convergence of viral evolution, ecological changes, human behavior, and public health limitations • Increased risk of health emergency due to climate change, emerging and engineered pathogens, global mobility, and geopolitical instability • Emerg

  7. Slide 7: Vaccines Against Smallpox and Mpox

    Vaccines Against Smallpox and Mpox Licensed second & third-generation smallpox / mpox vaccines • Vaccines used during the smallpox eradication campaign based on live vaccinia virus (replication-competent) First • Produced directly on the skin of live animals (e.g: Dryvax®) generation • Highly effect

  8. Slide 8: MVA (Modified Vaccinia Ankara): a Potent Smallpox and Mpox Vaccine

    MVA (Modified Vaccinia Ankara) : a Potent Smallpox and Mpox Vaccine • MVA was obtained from the CVA1 vaccinia virus isolate by Pr. A. Mayr in late 70's after 572 passages onto chicken embryo fibroblasts (CEF) • Lost over 15% of the viral genome (6 major deletions), including host range restriction g

  9. Slide 9: Orthopox-Related Threats: a Strategic Preparedness Challenge

    Orthopox-Related Threats : a Strategic Preparedness Challenge • Challenge as vaccine supply is fragile • Current system depends on too few suppliers • Single supplier (monopoly) for MVA vaccine (Bavarian Nordic) with limited capacity and centralized production • Europe relies on a single approved mp

  10. Slide 10: TG-MVA | Building Next Line of Biosecurity Against Pox-Diseases

    TG-MVA | Building Next Line of Biosecurity Against Pox-Diseases • TG-MVA : A Safe Third-Generation Vaccine • Non-replicating pox vaccine built on a viral backbone identical to Bavarian Nordic’s reference platform: shared MVA lineage (100% Region of Interest (ROI) sequence identity) • Designed to pro

  11. Slide 11: TG-MVA | Pre-Clinical Studies

    TG-MVA | Pre-Clinical Studies Generated non-clinical evidence of TG-MVA efficacy, immunogenicity & safety Objective: to compare the efficacy, immunogenicity & safety of TG-MVA and MVA-BN® in established Non-human primates and murine animal models Immunogenicity study mpox lethal-challenge mpox letha

  12. Slide 12: Immunogenicity in BALB/c Mice: Study Design

    Immunogenicity in BALB/c Mice: Study Design • Tested items • MVA-BN® (Jynneos®) : registered as a prophylactic vaccine against Mpox and smallpox, produced on CEF • TG-MVACEF (TG4080) : TG-MVA produced on CEF • TG-MVACL (TG4090) : TG-MVA produced on avian cell line • Vehicule: formulation buffer Obje

  13. Slide 13: Immunogenicity in BALB/c Mice: Antibodies Response

    Immunogenicity in BALB/c Mice: Antibodies Response TG-MVA induce Total and Neutralizing VACV Ab comparable to MVA-BN® Total Ab detected at D42/D43 Neutralizing Ab detected at D42/D43 LOD *** *** LOD *** *** *** *** *** p<0.001, **p<0.01, * p<0.05 Total Anti-VAVC titers expressed as IC50 for individu

  14. Slide 14: Immunogenicity in BALB/c Mice: Cellular Response Assessed by ELISpot

    Immunogenicity in BALB/c Mice : Cellular Response Assessed by ELISpot TG-MVA and MVA-BN® induce similar cellular immune response Stimulation : Not infected P815 cells : P815 cells infected with VACV strain Western Reserve : mix of 3 specific MVA peptides : mix of 3 specific WR peptides Detection of

  15. Slide 15: Mpox Lethal-Challenge Study in CAST/Ei Mice: Study Design

    Mpox Lethal-Challenge Study in CAST/Ei Mice: Study Design Objective: Demonstrate that TG-MVA and MVA-BN® have similar immunogenicity and that change of manufacturing process has no impact on immunotoxic potential compared to manufacturing on CEF ➢ CAST/Ei mice* is a strain of mice for which MPXV cha

  16. Slide 16: Mpox Lethal-Challenge Study in CAST/Ei Mice: Survival and Weight Loss

    Mpox Lethal-Challenge Study in CAST/Ei Mice : Survival and Weight Loss TG-MVA and MVA-BN® provide equivalent protection against MPXV challenge Survival Weight loss ➢ No lethality in all MVA-vaccinated group ➢ Minor weight loss in MVA-vaccinated mice 16

  17. Slide 17: TG-MVA | Conclusions in Mice Models

    TG-MVA | Conclusions in Mice Models • Primary end-point: Protection is reached (CAST/Ei mice) for all three MVAs and with identical efficacy (100% for all groups) • Secondary end-points: Morbidity/Immunogenicity o Weight Loss : minimal and same weight loss for the three MVA vaccines groups o MPXV ne

  18. Slide 18: Mpox Lethal-Challenge Study in NHP: Study Design

    Mpox Lethal-Challenge Study in NHP: Study Design A gold-standard for anti-Mpox vaccine evaluation Objective: Demonstrate that TG-MVA and MVA-BN® have similar immunogenicity and that change of manufacturing process has no impact on immunotoxic potential compared to manufacturing on CEF NHP Vehicle MP

  19. Slide 19: Mpox Lethal-Challenge Study in NHP: Survival and Weight Loss

    Mpox Lethal-Challenge Study in NHP : Survival and Weight Loss TG-MVA and MVA-BN® provide equivalent protection against MPXV challenge : MVA-BN® : TG-MVA_CEF : MVA-BN® : TG-MVA_CEF (Log-rank p=0.0001) : TG-MVA_CL : TG-MVA_CL ➢ 7/8 animals survived in all MVA-vaccinated group ➢ Minor weight loss in MV

  20. Slide 20: Mpox Lethal-Challenge Study in NHP: Lesion Counts

    Mpox Lethal-Challenge Study in NHP: Lesion Counts TG-MVA and MVA-BN® strongly protect against MPXV-induced lesion development : MVA-BN® Number of animal : TG-MVA_CEF With lesions* Without lesions : TG-MVA_CL MVA-BN® 7 (87,5%) 1(12,5%) TG-MVACEF 8 (100.0%) 0 (0%) TG-MVACL 5 (62.5%) 3 (37.5%) Vehicle

  21. Slide 21: NHP: Neutralizing anti-VACV Ab

    Mpox Lethal-Challenge Study in NHP: Neutralizing anti-VACV Ab TG-MVA and MVA-BN® provide similar immunogenicity against VACV MPXV Challenge Anti-VAVC neutralization titers expressed as NT50. Data represents geometric mean for each group. ➢ Prior to challenge, peak of response at D42 ➢ Comparable Tit

  22. Slide 22: NHP: Neutralizing anti-MPXV

    Mpox Lethal-Challenge Study in NHP: Neutralizing anti-MPXV TG-MVA and MVA-BN® provide similar immunogenicity against MPXV a Anti-MPXV neutralization titers expressed as NT50. Data represents geometric mean for each group. • Prior to challenge, peak of response at D42 • Prior to challenge, peak of re

  23. Slide 23: NHP: Total Antibodies Against VACV Proteins

    Mpox Lethal-Challenge Study in NHP: Total Antibodies Against VACV Proteins* TG-MVA and MVA-BN® provide similar immunogenicity against VACV proteins * : Orthologous late proteins from IMV and EEV viral particle known to be associated with protection Mean of log concentration of VACV protein-binding I

  24. Slide 24: NHP: Total Antibodies Against MPXV Proteins

    Mpox Lethal-Challenge Study in NHP : Total Antibodies Against MPXV Proteins* TG-MVA and MVA-BN® provide similar immunogenicity against MPXV proteins * : Orthologous late proteins from IMV and EEV viral particle known to be associated with protection Mean of log concentration of MPXV protein-binding

  25. Slide 25: NHP: Cellular Response Assessed by ELISpot

    Mpox Lethal-Challenge Study in NHP: Cellular Response Assessed by ELISpot TG-MVA and MVA-BN® induce similar cellular immune response Stimulation: PepMix Pan-Poxviridae Select 127 peptides class I & II restricted T-cells epitopes) - 122 found in MPXV - 126 found in VACV WR Detection of IFN-gamma prod

  26. Slide 26: NHP: Viremia in Blood and Throat Swab

    Mpox Lethal-Challenge Study in NHP: Viremia in Blood and Throat Swab TG-MVA and MVA-BN® provide markedly attenuated systemic viral burden Log10 MPXV genome copy numbers. Data represents mean +/-SEM Log10 MPXV genome copy numbers. Data represents mean +/-SEM TG-MVA_CL : Only 1 positive NHP from J18 •

  27. Slide 27: Safety Assessment

    Safety Assessment Similar safety profile among all three vaccines Safety end-points were incorporated in the NHP efficacy study : • Hematology/biochemistry : • Variations observed after MPXV exposure consistent with viral infection (increased WBC, slight increased of liver enzymes and globulin conce

  28. Slide 28: TG-MVA | Conclusions

    TG-MVA | Conclusions • TG-MVACEF and TG-MVACL demonstrate efficacy, immunogenicity and safety comparable to MVA-BN® • Protection for severe mpox morbidity and mortality • Induction of comparable level of Neutralizing anti-VACV antibody • Comparable peak viremia levels observed in blood and throat sw

  29. Slide 29: Acknowledgments

    Acknowledgments Jean-Baptiste Marchand Kar Swagata Patricia Kleinpeter Bhavna Chawla Véronique Koerper Christelle Remy Hakim Makhloufi Bérangère Marie-Bastien Clémentine Spring-Giusti Geneviève Inchauspé Emmanuelle Dochy Maurizio Ceppi Laurence Laruelle Sarkar Sanjay Martine Marigliano Jessica Marti

  30. Slide 30: Thank you for your attention

    Thank you for your attention 30

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