Moderna, Inc. · NASDAQ:MRNA
Moderna — 7th ReSViNET Conference (RSVVW 2023)
15 slides from Moderna's conference presentation, Feb 23, 2023
Slide 1: Safety and Efficacy of mRNA-1345, an mRNA-based Vaccine Against RSV, in Adults 60 Years and Older
Safety and Efficacy of mRNA-1345, an mRNA-based Vaccine Against Respiratory Syncytial Virus, in Adults 60 Years and Older Eleanor Wilson, Jaya Goswami, Sonia K. Stoszek, Runa Mithani, Shraddha Mehta, Archana Kapoor, Wenmei Huang, Lan Lan, Laila El Asmar, Catherine A. Panozzo, Parinaz Ghaswalla, Alli
Slide 2: Disclosures, Acknowledgments, and Abstract Plain Language Summary
Disclosures, Acknowledgments, and Abstract Plain Language Summary • EW, JG, SKS, RM, SM, AK, WH, LL, LEA, CAP, PG, AA, CAS, JM, and GLC are employees of Moderna, Inc., and hold stock/stock options in the company • Medical writing and editorial assistance were provided by Jared Mackenzie, PhD, of MED
Slide 3: mRNA-1345, an mRNA-based RSV Vaccine, Encodes for a Stabilized Prefusion F Glycoprotein
mRNA-1345, an mRNA-based RSV Vaccine, Encodes for a Stabilized Prefusion F Glycoprotein • mRNA-1345 is an mRNA-based RSV v accine candidate consisting of a single mRNA sequence encoding the membrane-anchored RSV F glycoprotein stabilized in the prefusion conformation – Prefusion F elicits superior n
Slide 4: mRNA-1345 Phase 2/3 Clinical Trial
mRNA-1345 Phase 2/3 Clinical Trial • In this ongoing phase 2/3, randomized, observer-blind, placebo-controlled, case-driven study in adults aged ≥60 years (NCT05127434)1, 35,541 participants from 22 countries were randomized 1:1 to receive 1 dose of mRNA -1345 50 µg or placebo – Healthy participants
Slide 5: mRNA-1345 Phase 2/3 Clinical Trial: Efficacy Endpoint Definition
mRNA-1345 Phase 2/3 Clinical Trial: Efficacy Endpoint Definition Two Primary Endpoint Definitions for RSV Lower Respiratory Tract Disease (LRTD) RSV LRTD with 2 or more lower respiratory symptoms RSV LRTD with 3 or more lower respiratory symptoms • RT-PCR-confirmed RSV PLUS • RT-PCR-confirmed RSV PL
Slide 6: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics mRNA-1345 Placebo mRNA-1345 Placebo (N=17,793) (N=17,748) (N=17,793) (N=17,748) Age at Enrollment (Years), Race Groups, n (%) 68.1 (6.19) 68.1 (6.20) Mean (SD) White 11,285 (63.4) 11,254 (63.4) Age Group, n (%) a Black 2210 (12.4) 2173 (12.2) 60 to 69 Years
Slide 7: Overview of Solicited Adverse Reactions
Overview of Solicited Adverse Reactions mRNA-1345 Placebo Solicited local adverse reactions within 7 days Solicited local adverse reactions within 7 days, 10,367/17,662 (58.7%) 2845/17,593 (16.2%) n/N (%) Grade 3 or greater cases, n/N (%) 558/17,662 (3.2%) 305/17,593 (1.7%) Solicited systemic advers
Slide 8: Percentage of Participants With Solicited Local Adverse Reactions Within 7 Days
Percentage of Participants With Solicited Local Adverse Reactions Within 7 Days • Pain at the injection site (mostly grade 1) was the most frequently reported local adverse reaction Note: Data are from the Solicited Safety Set analysis population. Summary of participants w ith solicited adverse reac
Slide 9: Percentage of Participants With Solicited Systemic Adverse Reactions Within 7 Days
Percentage of Participants With Solicited Systemic Adverse Reactions Within 7 Days • Arthralgia, fatigue, headache, and myalgia were the most frequently reported systemic adverse reactions Note: Data are from the Solicited Safety Set analysis population. Summary of participants w ith solicited adver
Slide 10: Efficacy of mRNA-1345 Against RSV LRTD
Efficacy of mRNA-1345 Against RSV LRTD mRNA-1345 Placebo (N=17,572) (N=17,516) RSV LRTD with ≥2 symptoms Cases, n/N (%)a,b 9/17,572 (0.05%) 55/17,516 (0.31%) V E (%) based on hazard ratios (alpha adjusted 95.88% CI)c 83.7% (66.0%, 92.2%) RSV LRTD with ≥3 symptoms Cases, n/N (%)a,b 3/17,572 (0.02%) 1
Slide 11: Efficacy of mRNA-1345 Against RSV LRTD Across Age Groups
Efficacy of mRNA-1345 Against RSV LRTD Across Age Groups • In adults ≥80 years, no cases of RSV LRTD with ≥2 or ≥3 symptoms were observed (mRNA-1345, n/N=0/964; PBO, n/N=0/982) Note: Data are from the Per-Protocol Efficacy Set analysis population, 14 days to 12 months post -injection. CI, confidence
Slide 12: Efficacy of mRNA-1345 Against RSV LRTD in Participants With Pre-existing Comorbidities
Efficacy of mRNA-1345 Against RSV LRTD in Participants With Pre-existing Comorbidities Note: Data are from the Per-Protocol Efficacy Set analysis population, 14 days to 12 months post-injection. CHF, congestive heart failure; CI, confidence interval; COPD, chronic obstructive pulmonary disease; LRTD
Slide 13: Conclusions
Conclusions • mRNA-1345 was well tolerated and had an acceptable safety profile; solicited adverse reactions were mostly grade 1 or grade 2 in severity • A single dose of mRNA-1345 50 µg is efficacious in preventing RSV LRTD with ≥2 or ≥3 symptoms in adults aged ≥60 years within 14 days to 12 months
Slide 14: Forward-Looking Statements and Disclaimer
Forward-Looking Statements and Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning potential development candidate applications, development candi
Slide 15: Thank you
Thank you Safety and Efficacy of mRNA-1345, an mRNA-based Vaccine Against Respiratory Syncytial Virus, in Adults 60 Years and Older. Prese nted at RSVVW 2023, Lisbon, Portugal. © 2023 M oderna, Inc. Confidential. All rights reserved.