Moderna : ECSMID 2025 (Mpox safety and immunogenicity)

Published: 2025-04-14 08:36:53 ET MRNA

Safety and Immunogenicity of mRNA mpox Vaccine Candidate mRNA-1769: Interim Analysis Results from a Phase 1/2 trial

Hiwot Hiruy,1 Rajeka Lazarus,2 Kieran McCafferty,3 Roxane Hasselbeck,1 Kristen Cohen,1 Rakesh Dhar,1 Tony Rizk,1 Abidemi Adeniji,1 Xiaolin Chang,1 Lisa Siquel,1 Hamilton Bennett,1 Brett Leav1

1Moderna Inc.; 2University of Bristol; 3Queen Mary University London and Bart's Health NHS Trust

Disclosures and Acknowledgments

-HH, RH, KC, RD, TR, AA,XC, LS, HB and BL are employees of Moderna Inc., may hold stock/stock options in the company.

-All relevant financial disclosures have been mitigated

We would like to thank the study participants, the study site teams, the Moderna mpox Core Team members, the Moderna Internal Independent Safety Team members, the National Institute of Health Vaccine Research Center and United States Army Medical Research Institute of Infectious Diseases for their contribution.

The study was funded by Moderna Inc.

are for personal use only and may not be reproduced without written permission of the authors

− For additional information, please contact Hiwot Hiruy ([email protected])

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 statements regarding: target product profile;

efficacy and safety; and the potential for regulatory approval. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the

negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this presentation are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those described in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov.Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements in this presentation in the event of new information, future developments, or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

Background: Mpox

Rimoin et al, 2010; McCollum et al, 2023; O'Toole et al, 2023; Kinganda-Lusamaki et al, 2025; Vakaniaki et al, 2025 Source of pictures; EM of mpox-CDC; WHO

Increase in Global Burden of Mpox

*WHO data as of January 31, 2025; #Africa CDC data as of March 12, 2025 *# include both confirmed and probable cases of mpox

WHO, 2022; WHO 2024

Source: CDC, data in the figure as of 16Jan2025

mRNA-1769 is comprised of Mature Virion(MV) and Enveloped Virion (EV) antigens

MV antigens

EV antigens

A29L

M1R

B6R

A35R

*Hooper et al(2003); Hooper et al. (2004); Edghill-Smith et al. (2005); Lustig et al. (2005); Golden et al. (2011)

#Freyn et al(2023); Mucker et al(2024), Cotter et al(2024)

mRNA-1769-P101 Overview

mRNA-1769-P101: Ongoing Phase 1/2 Trial (NCT05995275)1

Randomized, observer-blind, placebo-controlled, dose-ranging study in healthy individuals aged 18-50 years

• 350 participants (18 to <50yo) were randomized

Key Endpoints With Data Available at Interim Analysis

Safety:

2:2:2:1 to 25µg, 50µg, 100µg or placebo treatment

groups, respectively

•

Local and systemic SARs assessed for 7 days after each

• Sequential enrollment; 12 sites in the UK

injection

• Pre-specified interim analysis (IA) when at least 50%

•

Unsolicited AEs monitored for 28 days after each injection

participants from each treatment group have

•

MAAEs, serious AEs, AESIs, AEs leading to discontinuation of IP

completed Day 57 visit

and/or study until end of study (Day 395)

➢ AESIs: anaphylaxis, myo/pericarditis, thrombocytopenia, new

onset neurological diseases (GBS, ADEM, Bells'palsy, seizures)

Immunogenicity:

•

MPXV-specific nAbs and VACV-specific nAB assessed at

Day 43 via PRNT

•

GMC of bAbs to MPXV and VACV antigens measured by

MSD assay through 57

•

T-cell response (CD4+ and CD8+) in a subset of participants

ADEM, acute disseminated encephalomyelitis; AE, adverse event; AESI, adverse event of special interest ; bAbs, binding antibodies; GBS, Guillian-Barre Syndrome; IP, investigational product; MAAEs, medically attended AEs; MPXVV, mpox virus; MSD, meso-scale discovery; nAbs, neutralizing antibodies; PRNT, plaque reduction neutralization test; SAR, solicited adverse reaction; VACV, vaccinia virus;1Clinicaltrials.gov. A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of

Age to <50 Years of Age, 1https://clinicaltrials.gov/study/NCT05995275?cond=mRNA-1769&rank=1

mRNA-1769 P101 Demographics and Baseline Characteristics (Safety Set)

Placebo

mRNA-1769

25 µg

50 µg

100 µg

N=51

N=98

N=101

AGE

Median(min, max)

(20, 49)

(19, 49)

(18, 49)

Gender (n, %)

Female

19 (37.3)

43 (43.9)

45 (45.9)

45 (44.6)

Male

32 (62.7)

55 (56.1)

53 (54.1)

56 (55.4)

Race (n, %)

White

42 (82.4)

81 (82.7)

84 (85.7)

77 (76.2)

Black

8 (15.7)

4 (4.1)

3 (3.1)

4 (4)

Asian

1 (2)

9 (9.2)

7 (7.1)

13 (12.9)

Multiple or other

4(4.1)

4 (4.1)

7 (6.9)

BMI (kg/m2)

26.8

26.4

25.8

Median (max, min)

(19.2, 38.5)

(18.4, 38.9)

(18.1, 38.9)

(18.1, 38.8)

mRNA-1769-P101 IA Safety Results

Disclaimer

Moderna Inc. published this content on April 14, 2025, and is solely responsible for the information contained herein. Distributed via , unedited and unaltered, on April 14, 2025 at 12:34 UTC.