Moderna, Inc. · NASDAQ:MRNA
Moderna — 35th Congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCM (April 2025)
14 slides from Moderna's conference presentation, Apr 12, 2025
Slide 1: Immunogenicity of JN.1- and KP.2-Encoding mRNA COVID-19 Vaccines Against JN.1 Sublineages
Immunogenicity of JN.1- and KP.2- Encoding mRNA COVID-19 Vaccines Against JN.1 SARS-CoV- 2 Sublineages in Adult Participants Amparo Figueroa, Darin Edwards, Kimball Johnson, David C. Montefiori, Bethany Girard, Steven Hack, Xin Cao, Elizabeth de Windt, Veronica Urdaneta, Frances Priddy, Rituparna Da
Slide 2: Disclosures and Acknowledgments
Disclosures and Acknowledgments • AF, DE, BG, SH, XC, EDW, VU, FP, RD, and SC are employees of Moderna, Inc., and hold stock/stock options in the company. KJ is an employee of CenExel and holds stocks in Moderna, Inc. DM has received research funding from Moderna, Inc. • Medical writing and editoria
Slide 3: Forward-Looking Statements
Forward-Looking Statements • This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: target product profile; efficacy and safety; and the potential for regulatory approval. In some c
Slide 4: mRNA-1273.167 (JN.1) and mRNA-1273.712 (KP.2)
mRNA-1273.167 (JN.1) and mRNA-1273.712 (KP.2) • COVID-19 is no longer considered to be a public health emergency; however, SARS-CoV-2 continues to cause illness, hospitalisation, and mortality1,2 o In the United States, 210,000−350,000 hospitalisations and 24,000–41,000 deaths were reported between
Slide 5: JN.1 family subvariants continue to evolve, differentiated by 8-10 Spike mutations
JN.1 family subvariants continue to evolve, with currently circulating subvariants differentiated from JN.1 by 8-10 Spike mutations 8-10 mutations • JN.1 became the dominant global variant in early 2024, with JN.1 subvariants continuing to evolve and circulate globally1,2 • Currently circulating JN.
Slide 6: mRNA-1273-P403: Immunogenicity of mRNA COVID-19 Variant-Encoding Vaccine Formulations
mRNA-1273-P403: Immunogenicity of mRNA COVID-19 Variant-Encoding Vaccine Formulations (NCT06585241) Phase 3b/4 open-label, single-arm design: Ongoing study with multiple subprotocols to assess immunogenicity and cross-neutralization against new variants 50 individuals aged ≥18 years per subprotocol
Slide 7: Participant Demographics and Baseline Characteristics
Participant Demographics and Baseline Characteristics Safety Seta JN.1 vaccine KP.2 vaccine mRNA-1273.167 (50 µg) mRNA-1273.712 (50 µg) N = 50 N = 50 Mean age (range), year 62 (35, 77) 53.6 (24, 79) Median age, years 63 53.5 Sex, female, % 31 (62) 33 (66) Age subgroup, % 18-65 years 27 (54) 37 (74)
Slide 8: mRNA-1273.167 (JN.1) and mRNA-1273.712 (KP.2) immunogenicity
mRNA-1273.167 (JN.1) and mRNA-1273.712 (KP.2) immunogenicity Per-Protocol Immunogenicity Seta • JN.1 and KP.2 vaccines mRNA-1273.167 50 µg (JN.1) neutralize matched variants and Neutralising Antibody Titre (ID 50) cross-neutralize circulating subvariants of JN.1 mRNA-1273.712 50 µg (KP.2) • Response
Slide 9: Cross-neutralised all tested JN.1 subvariants
mRNA-1273.167 (JN.1) and mRNA-1273.712 (KP.2) cross-neutralised all tested JN.1 subvariants Per-Protocol Immunogenicity Seta • Neutralization of currently circulating subvariants was 1.7-3.4-fold lower Neutralising Antibody Titre (ID50) than vaccine matched variants LLOQ, lower limit of quantitation
Slide 10: No new safety concerns observed through 28 days
No new safety concerns observed through 28 days after mRNA-1273.167 (JN.1) and mRNA-1273.712 (KP.2) Safety Set; Up to 28 Days After Vaccination • Safety was evaluated as a secondary objective, with endpoints including SAEs, AEs leading to study discontinuation, and AESIs • There were no deaths, SAEs
Slide 11: Summary
Summary Immunogenicity Safety • Our neutralisation results demonstrate that • No SAEs, AEs leading to the study withdrawal, both the JN.1 and KP.2 vaccines induce or AESIs related to study vaccine were robust nAb responses to vaccine matched reported following vaccination with antigens mRNA-1273.167
Slide 12: Thank you
Thank you © 2025 Moderna, Inc. All rights reserved.
Slide 13: Vaccination with mRNA-1273.167 (JN.1) cross-neutralised matched and circulating subvariants
Vaccination with mRNA-1273.167 (JN.1) cross-neutralised matched and currently circulating subvariants of JN.1 Per-Protocol Immunogenicity Seta mRNA-1273.167 (50 µg) N = 49 JN.1 KP.2 KP.3.1.1 XEC LP.8.1 Baseline (Day 1) 143.1 116.0 46.4 64.4 63.5 GMT (95% CI) (91.2, 224.6) (75.3, 178.6) (28.9, 74.3)
Slide 14: Vaccination with mRNA-1273.712 (KP.2) cross-neutralised matched and circulating subvariants
Vaccination with mRNA-1273.712 (KP.2) cross-neutralised matched and currently circulating subvariants of JN.1 Per-Protocol Immunogenicity Seta mRNA-1273.712 (50 µg) N = 49 KP.2 JN.1 KP.3.1.1 XEC LP.8.1 Baseline (Day 1) 163.2 259 89.2 133.3 114.4 GMT (95% CI) (106.9, 249.3) (165.2, 406) (55.9, 142.3)