Moderna, Inc. · NASDAQ:MRNA
Moderna — Technical Presentation (June 2022)
13 slides from Moderna's technical presentation, Jun 8, 2022
Slide 1: Bivalent COVID Booster Ph 2/3 Interim Analysis (mRNA-1273.214)
DNA mRNA Protein Bivalent COVID Booster Ph 2/3 Interim Analysis (mRNA-1273.214) June 8th, 2022
Slide 2: 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 statements regarding: Moderna’s expectations regarding the endemic phase of COVID-19, including trends wit
Slide 3: COVID booster development for endemic phase
COVID booster development for endemic phase • Neutralizing titers (NT) will wane, similar to endemic HCoV • Decline in NT will increase risk of breakthrough hospitalization for Strategic rationale those at higher risk (e.g., older adults, immune compromised) for seasonal booster • Emergence of new v
Slide 4: Overview Phase 2/3 (P205) study for mRNA-1273.214
Overview Phase 2/3 (P205) study for mRNA-1273.214 All subject received mRNA-1273 primary series (100 µg) and mRNA-1273 booster (50 µg) 4th dose Trial Booster Dose Subjects(n) Comments Phase mRNA- 50 µg 377 Enrolled February m RNA-1273.214 also 2/3 1273 21 to March 8 being evaluated in study in UK (P
Slide 5: Primary immunogenicity objectives for the Phase 2/3 study (P205)
Primary immunogenecity objectives for the Phase 2/3 study (P205) The Day 29 testing sequence for the immunogenecity endpoints is the following: Non-inferiority (GMR) Non-inferiority (SRR difference) Non-inferiority (GMR) Ancestral SARS-CoV-2 Day 29 Omicron Day 29 Omicron Day 29 Yes Yes Yes Superiori
Slide 6: Demographics and baseline characteristics were consistent between groups
Demographics and baseline characteristics were consistent between groups mRNA-1273.214 mRNA-1273 Characteristics n (%) (50 µg), N=437 (50 µg), N=377 Age at Screening (yr) Mean (range) 57.3 (20, 88) 57.5 (20, 96) Age subgroup ≥18 and <65 years 263 (60.2) 227 (60.2) ≥65 years 174 (39.8) 150 (39.8) Gen
Slide 7: Solicited adverse reactions were consistent with prior doses
Solicited adverse reactions were consistent with prior doses Solicited adverse reactions within 7 days of the dose Local Syst emic Solicited adverse reactions trended lower for mRNA-1273.214 compared to prior doses Frequency and types of unsolicited adverse events were also comparable, with no vacci
Slide 8: Omicron neutralizing titers (PsVNT50)
Omicron neutralizing titers (PsVNT50) All part icipants Seronegative Seropositive mRNA-1273 (prototype) mRNA-1273.214 (biv alent) 10000 Omicron Omicron neutralizing titers neutralizing were significantly higher antibody titers 1000 following bivalent (.214) (PsVNT50) booster compared to prototype fo
Slide 9: Bivalent booster (.214) resulted in superior neutralizing GMT against Omicron
Bivalent booster (.214) resulted in superior neutralizing GMT against Omicron Only baseline seronegative participants mRNA-1273.214 mRNA-1273 50 µg (N=334) 50 µg (N=260) • All primary and key secondary Pre-booster GMT, 95% 298.13 332.02 immunogenicity objectives were met CI (258.75, 343.49) (282.05,
Slide 10: Bivalent booster (.214) resulted in superior neutralizing GMT against Omicron
Bivalent booster (.214) resulted in superior neutralizing GMT against Omicron All participants mRNA-1273.214 mRNA-1273 • Bivalent booster (.214) resulted in 50 µg (N=428) 50 µg (N=367) superior neutralizing GMT against Pre-booster GMT, 95% 432.05 511.98 Omicron compared to mRNA- CI (372.47, 501.17)
Slide 11: Bivalent booster (.214) elicited higher neutralizing antibody titers against ancestral SARS-CoV-2 (D614G)
Bivalent booster (.214) elicited higher neutralizing antibody titers against ancestral SARS-CoV-2 (D614G) SARS-CoV-2 negative pre-booster part icipants All part icipants mRNA-1273.214 mRNA-1273 mRNA-1273.214 mRNA-1273 50 µg (N=334) 50 µg (N=260) 50 µg (N=428) 50 µg (N=367) Pre-booster GMT, 95% 1266.
Slide 12: Conclusions
Conclusions • The mRNA-1273.214 50 μg booster dose was well-tolerated and the safety and reactogenicity profile was similar to that of the prototype mRNA-1273 50 μg booster dose • All primary and key secondary immunogenicity objectives were met: – mRNA-1273.214 (50 μg) elicited a superior neutralizi
Slide 13: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 13