Following Daiichi Sankyo’s recent accomplishment of securing Japan’s first mRNA vaccine approval, a potential competitor has emerged backed by significant financial support from the Japanese government.
Arcalis, an mRNA-focused Contract Development and Manufacturing Organization (CDMO) formed as a joint venture between Arcturus Therapeutics and Japanese drug discovery service provider Axcelead, has been awarded two grants amounting to $115 million by the Japanese government. These grants, provided in December 2021 and October 2022, aim to bolster the production of mRNA vaccines and therapeutics.
The funding serves a dual purpose, aiding in the establishment of Arcalis’ vaccine manufacturing facility in Minamisoma, Japan, and supporting the manufacturing processes for mRNA drug substances and final products. The spokesperson for Arcturus shared this information with Fierce Pharma.
Arcalis has completed the construction of the drug substance portion of its plant, spanning a vast area of 1,933 square meters and boasting an extensive floor space of 7,252 square meters. The company’s plans include completing the construction of the drug product plant by 2026.
This development comes on the heels of Arcturus’ local collaborator, Meiji Seika Pharma, submitting an application for Arcturus’ self-amplifying mRNA COVID-19 vaccine, ARCT-154, to Japanese regulatory authorities. A decision on the application is anticipated in the fourth quarter. Notably, ARCT-154 is administered at a dosage of 5mcg per shot, and with Arcalis’ yearly capacity of 5kg of drug substance, the company can potentially produce mRNA substance for up to 1 billion doses of the vaccine.
Arcturus’ journey faced a setback when ARCT-154 demonstrated only 55% efficacy as a primary immunization series against symptomatic COVID-19 in a large Phase III trial in Vietnam. However, the company rebounded with positive booster data from a Japanese Phase III trial, showcasing its effectiveness against the omicron variant. This rebound prompted a strategic partnership with CSL Seqirus, with CSL paying Arcturus $200 million upfront for self-amplifying mRNA technology rights and potential milestone payments exceeding $4 billion.
While Japan recently approved Daiichi Sankyo’s mRNA vaccine Daiichirona, targeting the original coronavirus strain, Meiji and Arcturus are pursuing an updated version of their vaccine, XBB1.5-targeted, with plans for a partial change application in early 2024.
This unfolding landscape highlights the dynamic competition in the mRNA vaccine space, with companies and their partnerships working towards effective solutions to combat evolving variants of the virus.
