Daiichi Sankyo Initiates Phase 1/2 Clinical Trial for mRNA COVID-19 vaccine in Japan

TOKYO, Japan I March 22, 2021 I Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) announced today it has started the first vaccinations in a phase 1/2 clinical trial in Japan of an mRNA vaccine (hereinafter, DS-5670) that is being developed by the company against the novel coronavirus infectious disease (hereinafter, COVID-19).

DS-5670 is being developed by Daiichi Sankyo’s proprietary novel nucleic acid delivery technology. Daiichi Sankyo is leading the research and development, in collaboration with the University of Tokyo’s Institute of Medical Science, through “Development of vaccines for the novel coronavirus disease (Second Round),” (company-initiated), which is promoted by the Japan Agency for Medical Research and Development. Results from preclinical studies suggest that positive safety and efficacy of DS-5670 have been confirmed.

The phase 1/2 trial is being conducted in Japan in a total of 152 healthy adults, including elderly individuals, to evaluate the safety and immunogenicity1 of the vaccine and thereby estimate the recommended dose of DS-5670. The endpoints for safety are adverse events and reactions, and those for immunogenicity are neutralizing antibody titer 2 and IgG titer3.

As a Japanese pharmaceutical company with specialty in developing vaccines, Daiichi Sankyo is striving to help restore safety and security in society through the early eradication of COVID-19, which it hopes to achieve by pursuing the development of DS-5670, a Japan-made vaccine against COVID-19, as well as by generating adequate supplies of DS-5670 as soon as possible.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma

Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: https://www.daiichisankyo.com/.

References

1 Immunogenicity is defined as the ability of a vaccine to induce immunity in a living human body.

2 Neutralizing antibody titer is defined as the amount of antibody needed to inhibit (neutralize) the infectivity of the virus.

3 IgG titer is defined as the indicator of the immune response to antigens of IgG, one of the antibodies.

SOURCE: Daiichi Sankyo

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