ARCALIS

ARCALIS is a contract development and manufacturing organization ("CDMO") for messenger RNA (mRNA) vaccines and therapeutics. The company was jointly established by Axcelead, Inc., the first drug discovery platform company in Japan, and Arcturus Therapeutics, a US-based global late-stage clinical mRNA medicines company. mRNA is a new therapeutic and vaccine modality that was only recently commercialized in the wake of the Coronavirus infection, but the challenge toward practical application has been ongoing since the 1990s. Although various technical obstacles (such as low stability of mRNA molecules) present challenges to the commercialization of these medicines, innovative work by many scientists and companies, have resulted in an accumulation of solutions that make practical applications possible. Research and development of mRNA have begun targeting not only infectious diseases but also therapeutics and vaccines for various applications, such as rare diseases, cancer, regenerative medicine, and genome editing. However, since RNA is a new field for therapeutic development, the industry still needs to overcome the following: - Challenges in drug discovery, such as identifying mRNA sequences to express the target protein or optimizing drug formulations to deliver the appropriate cell and tissues. - Manufacturing challenges that include designing reproducible and robust analytical and manufacturing methods. ARCALIS was founded in 2021 as a joint venture between Axcelead, Inc. and Arcturus Therapeutics to provide solutions to these challenges. The company provides drug discovery support, CMC development, and manufacturing support services for mRNA therapeutics and vaccines to pharmaceutical and biotech companies. These services are backed by expertise accumulated in Arcturus in the fields of manufacturing technologies.