Daiichi Sankyo to Launch mRNA COVID-19 Vaccine in 2022, Shionogi Presents Clinical Results of COVID-19 Oral Drug

Japan has become a rather unexpected COVID-19 success story. In merely two months, its confirmed cases have dropped from over 22,000 in mid-August to under 500 in mid-October. What’s more, Japanese firms have made clinical progress in developing a homegrown COVID-19 vaccine and an oral antiviral drug. Their efforts may accelerate the revival of Japan’s economy and return of social activities.

First Homegrown mRNA COVID Vaccine to Enter Market in 2022

Daiichi Sankyo has unveiled a plan to commercialize its COVID-19 vaccine DS-5670 in 2022. The vaccine is Japan’s first homegrown mRNA COVID-19 vaccine and is being investigated in the Phase 1/2 clinical trial.

The Japanese firm will advance DS-5670 to Phase 2 trial in November and start Phase 3 trial in the fiscal year 2021. Furthermore, it’s in talks to commence a clinical trial for a booster dose in January 2022. Ultimately, Daiichi Sankyo expects the vaccine to be approved and sold in Japan in 2022.

DS-5670’s Phase 1/2 trial began in March 2021. The vaccine demonstrated positive data in safety and immunogenicity where the neutralizing activity and IgG titer increased after the vaccination. On the other hand, non-clinical research also showed DS-5670 is able to neutralize certain variants of concern, including the Delta variant.

Shionogi Reveals Phase 1 Result of its COVID Oral Drug

Shionogi presented the non-clinical and clinical data of its COVID-19 antiviral drug S-217622 at the ISIRV-WHO virtual conference. The findings support S-217622’s potential to be a once-daily oral drug used to decrease the viral load.

S-217622 is a 3CL protease inhibitor that can suppress an enzyme involved in virus replication. Shionogi said the drug is able to greatly decrease the Covid-19 viral load in animal studies, and the metabolism and pharmacokinetics profile is good enough for it to become an orally administered drug. Specifically, the company found that plasma concentrations of the drug exceeded the target concentration required for viral reduction.

A Phase 2/3 trial of S-217622 commenced in late September. Shionogi will examine the efficacy and safety of the drug in patients with mild or asymptomatic COVID-19.

Japan’s COVID Vaccine Status Quo

Japan has approved the 3 COVID-19 vaccines developed by Pfizer, Moderna, and AstraZeneca. Domestic pharma has also picked up the pace in vaccine development in 2021. Among them, AnGes has made the most progress in trials with 2 vaccines AG0302-COVID19 and AG0301-COVID19 in Phase 2/3 and Phase 1/2 trials respectively. Meanwhile, Shionogi’s S-268019, Daiichi Sankyo’s DS-5670a, and KM Biologics’s KD-414 are in Phase 1/2 trials.

Author

Tyler Chen

"Never go to a doctor whose office plants have died."- Erma Bombeck