FY2022 Q3 Financial and R&D Update slide image

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 30
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