Right after Daiichi Sankyo picked up Japan's first mRNA vaccine approval, a potential rival has revealed substantial financial backing from the Japanese government.
The Japanese government awarded two grants totaling $115 million to Arcalis to support the production of mRNA vaccines and therapeutics. Arcalis is an mRNA-focused CDMO joint venture by Arcturus Therapeutics and Japanese drug discovery service provider Axcelead.
The money was granted in December 2021 and October 2022 to support the construction of Arcalis’ vaccine factory in the Japanese city of Minamisoma and to support the manufacturing of mRNA drug substance and final drug product, respectively, an Arcturus spokesperson told Fierce Pharma.
Arcalis completed construction of the drug substance part of the plant at the end of July. The facility occupies an area of 1,933 square meters (nearly half an acre) and boasts total floor space of 7,252 square meters (more than 78,000 square feet). The company plans to finish building the drug product plant by 2026.
The news comes a few months after Arcturus’ local partner Meiji Seika Pharma submitted to Japanese authorities an application for Arcturus’ self-amplifying mRNA COVID-19 vaccine, ARCT-154. Meiji expects to receive a verdict on the application in the fourth quarter.
The vaccine is dosed at 5mcg per shot. Given Arcalis’ annual capacity of 5kg of drug substance per year, the company can make mRNA substance for up to 1 billion doses of the shot, the Arcturus spokesperson said.
Arcturus' program suffered a major setback in April 2022, when ARCT-154 showed only 55% efficacy as a primary immunization series against symptomatic COVID in a large phase 3 trial in Vietnam. But the company came back last month with booster data from a Japanese phase 3 trial. That trial found that ARCT-154 matched up to Pfizer and BioNTech’s Comirnaty at inducing immune responses against the original coronavirus strain and was superior in neutralizing antibody responses against omicron BA.4/5.
Before the phase 3 booster readout, Arcturus in November inked a strategic collaboration with CSL Seqirus, out-licensing its self-amplifying mRNA technology covering COVID, influenza, pandemic preparedness and three other globally prevalent respiratory infectious diseases to the vaccine giant. To get those rights, CSL paid Arcturus $200 million upfront, and more than $4 billion in potential milestones are on the line. Meiji is technically CSL’s partner in Japan.
Meiji has already signed a production contract with Arcalis, but the Arcturus spokesperson declined to comment on any other clients the CDMO may have.
Earlier this month, Japan approved (PDF) Daiichi Sankyo’s mRNA vaccine Daiichirona, also known as DS-5670, as the first home-grown COVID shot after over six months of review. But because Daiichirona targets the original coronavirus, Daiichi said it won’t be able to immediately supply the shot for the upcoming vaccination season. Instead, the Japanese pharma company plans to advance an XBB.1.5-based vaccine, hoping to make it available by the end of this year at the earliest.
Meiji and Arcturus are also working on an updated XBB1.5-targeted shot, with a potential partial change application planned for early 2024.
Both Comirnaty and Moderna’s Spikevax are also available in Japan.