FY2022 Q3 Financial and R&D Update
DS-5670
Dose 1
Dose 2
ComirnatyⓇ
Dose 1
Dose 2
Booster vaccination Ph1/2/3 Study Part 2
(non-inferiority verification part)
The 26th Annual Meeting of the Japanese Society of vaccinology
Dose 3
DS-5670a
ok
R
Dose 3
Dose 3
ComirnatyⓇ
DS-5670a
Daiichi-Sankyo
Non-inferiority verification of DS-5670a against approved
mRNA vaccines
GMFR ratio (DS-5670a/ ComirnatyⓇ)
SpikevaxⓇ
R
어
Dose 3
Spikevax®
Booster vaccination Ph1/2/3 Study Part 2 (non-inferiority verification part)
Subjects: Healthy adults and the elderly subjects who received the primary
vaccination (the first and second dose) of approved COVID-19 mRNA vaccine
(ComirnatyⓇ or Spikevax ®) in Japan
■Primary endpoint: Geometric mean fold rise (GMFR) of serum neutralizing
antibody titer against SARS-CoV-2 (original strain) after four weeks (Day 29) from
the administration of study drug
Secondary endpoints: Geometric mean titer (GMT) and seroconversion rate of
serum neutralizing against SARS-CoV-2 (original strain) after four weeks (Day 29)
from the vaccination, etc
0.5
0.67
GMFR ratio (DS-5670a/ Spikevax®)
0.5
0.67
1
1
2
2
GMFR ratio (DS-5670a/Comrnaty® or Spikevax®) of serum neutralizing antibody
titer against SARS-CoV-2 on Day 29 was calculated. The result demonstrated
non-inferiority of DS-5670a arm to control arms with the two-sided 97.5% lower
confidence interval exceeding the non-inferiority margin 0.67.
Rates of TEAE and severity of DS-5670a arm were comparable to those of control
arms
Confirmed efficacy and safety of DS-5670a booster vaccination in subjects who received
approved mRNA vaccine as the primary vaccination
Verified non-inferiority of DS-5670a booster vaccination in statistical comparison with
ComirnatyⓇ and Spikevax ® booster vaccination
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