Daiichi Sankyo Initiates Phase 2 Trial of mRNA Vaccine Against COVID-19 (DS-5670) in Japan

TOKYO, Japan I November 17, 2021 I Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) today announced that the first patient has been dosed in a phase 2 trial in Japan of DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (COVID-19).

This phase 2 trial is being conducted in 80 unvaccinated healthy adults using a batch of DS-5670 from the optimized manufacturing process to evaluate the safety and determine the recommended dose of DS-5670. If successful, a phase 3 trial of DS-5670 will be initiated within FY2021.

Daiichi Sankyo also will continue discussions with the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to determine next steps for initiating development of a supplemental (booster) dose of DS-5670 by January 2022.

As a Japanese pharmaceutical company with a 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 and commercialization of DS-5670 in Japan during 2022.

About DS-5670

DS-5670 is an mRNA vaccine against COVID-19 using a novel nucleic acid delivery technology discovered by Daiichi Sankyo. It is anticipated to be safe and efficacious by targeting the receptor binding domain (RBD) of the new coronavirus.

The clinical development of DS-5670 is being conducted through “Development of vaccines for the novel coronavirus disease (COVID-19) (Second Round)” (company-initiated) promoted by Japan Agency for Medical Research and Development (AMED) and “Urgent improvement project for vaccine manufacturing systems” supported by MHLW.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world- class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical need. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit www.daiichisankyo.com.

SOURCE: Daiichi Sankyo

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