Daiichi Sankyo Initiates First-in-Human Dosing in Phase I/II Clinical Trial of mRNA COVID-19 Vaccine DS-5670 in Japan Amid Global Pandemic Surge

March 23, 2021 News /BioValleyBIOON/ -- At present, the COVID-19 epidemic overseas is still spreading rapidly. According to Baidu's "Real-time Data on the Novel Coronavirus Pneumonia Epidemic"Big DataReport》 As of 15:00 on March 23, 2021, the global cumulative number of confirmed cases exceeded 100 million (124.29 million), and the number of deaths exceeded 2.735 million.

Recently, Daiichi Sankyo announced the Phase I/II clinical trial of its mRNA vaccine (DS-5670) for coronavirus disease 2019 (COVID-19) conducted in JapanClinical Trial, vaccination of subjects has commenced.

mRNA is a nucleic acid molecule that carries genetic information. mRNA vaccines deliverGeneticsInformation is introduced into the body, prompting cells to produce corresponding antigens, thereby inducing the human body to generate neutralizing antibodies and stimulate T-cell responses, combating viruses through the dual mechanisms of humoral and cellular immunity. In the face of sudden major outbreaks, compared with traditional vaccines, mRNA vaccine synthesis andManufacturing ProcessRelatively convenient, with strong immunogenicity, does not require additional adjuants necessary for traditional vaccines, and has good safety.

Currently, fromPfizer/BioNTech’s mRNA vaccine Comirnaty (BNT162b2) and Moderna’s mRNA vaccine mRNA-1273 have received emergency use authorization, temporary authorization, or conditional approval in multiple countries worldwide.

Just recently, Moderna announced that its next-generation vaccine, mRNA-1283, in Phase IClinical TrialsThe first cohort of subjects was immunized with this next-generation vaccine, which has the potential to remain stable under refrigerated storage conditions, thereby facilitating large-scale distribution and vaccination.

DS-5670 was developed using Daiichi Sankyo’s proprietary novel nucleic acid delivery technology. In collaboration with the Institute of Medical Science, The University of Tokyo, Daiichi Sankyo is leading the research and development under the “Development of Vaccines for Coronavirus Disease (Second Round)” project (company-initiated), which is promoted by the Japan Agency for Medical Research and Development (AMED). Preclinical study results have demonstrated the favorable safety and efficacy profile of DS-5670.

This Phase 1/2 trial currently underway in JapanClinical TrialsIn total, 152 healthy adults (including elderly individuals) were enrolled to evaluate the safety and immunogenicity of the vaccine, thereby estimating the recommended dose of DS-5670. The safety endpoints were adverse events andAdverse Reactions, the immunogenicity endpoints are neutralizing antibody titers and IgG titers.

As a Japanese pharmaceutical company specializing in vaccine research and development, Daiichi Sankyo Company Limited is committed to helping restore social safety and security through the early eradication of COVID-19. The company aims to achieve this goal by developing a domestically produced COVID-19 vaccine in Japan and providing sufficient quantities of DS-5670 as rapidly as possible.

Currently, the field of COVID-19 vaccine development is progressing at an unprecedented scale and speed. According to information from the World Health Organization (WHO) website, as of February 18, 2021, at least seven different vaccines were being rolled out across multiple countries on three platforms. Vulnerable populations in all countries are the highest priority for vaccination.

Meanwhile, as of March 16, 2021, more than 200 candidate vaccines were under development, with 82 in clinical development and 182 in preclinical development.

Of the 82 vaccines in clinical development, the majority (71 vaccines) primarily employ the following five technological platforms: protein subunit (PS, n=27, 33%), viralCarrier(non-replicating, VVnr, n=12, 15%), inactivated virus (IV, n=11, 13%), RNA (n=10, 12%). The remaining vaccines (11) adopted the following technological routes: viralCarrier(replicating vector, VVr, n=4, 5%), virus-like particles (VLP, n=3, 4%), VVr + antigen-presenting cells (VVr+APC, n=2, 2%), live attenuated virus (LAV, n=1, 1%), and VVnr+APC (n=1, 1%).

Of these 82 vaccines, 12 (15%) require a single-dose regimen, 50 (61%) require a two-dose regimen, 1 (1%) requires a three-dose regimen, and 19 (23%) have undetermined or unavailable data. (Bioon.com)

Original Sources: Daiichi Sankyo, World Health Organization, Bioon