An mRNA approach to vaccination

SAN DIEGO & SOMERSET, N.J.—Arcturus Therapeutics Holdings Inc., a leading clinical-stage messenger RNA (mRNA) medicines and vaccines company, and Catalent Inc., a global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, cell and gene therapies, have announced a partnership to support the expected manufacture of Arcturus’ COVID-19 mRNA vaccine candidate (LUNAR-COV19), intended to protect against the SARS-CoV-2 coronavirus.

LUNAR-COV19 utilizes Arcturus’ self-transcribing and replicating mRNA (STARR) technology and the vompany’s LUNAR lipid-mediated delivery to produce what they say is "an extraordinarily low dose, potential single-shot COVID-19 vaccine."

The manufacture of LUNAR-COV19 at Catalent’s drug substance biomanufacturing facility in Madison, Wis., will support human clinical studies and, if successful, commercialization of the vaccine. The COVID-19 vaccine program will take advantage of the facility’s flex-suite, a cGMP manufacturing suite that can produce batches at multiple scales and support Arcturus’ proprietary mRNA manufacturing process.

The partnership will combine Arcturus’ low-dose STARR mRNA vaccine technology with Catalent’s scalable cGMP manufacturing capabilities to produce millions of doses of LUNAR-COV19 mRNA in 2020 and potentially hundreds of millions of doses annually for worldwide use. Preparations for this program have already begun at the Madison facility, and both organizations say they are committed to meeting the global demand on "unprecedented manufacturing timelines." Technology transfer will be completed this month and manufacture of the first cGMP batches of LUNAR-COV19 mRNA are expected to be completed by June 2020.

“Catalent is proud to partner with Arcturus in the pursuit of a vaccine that could protect people against the coronavirus pandemic,” said John Chiminski, CEO of Catalent. “Our unique experience and flex-suite cGMP capacity will enable rapid scale-up of Arcturus’ proprietary manufacturing process to make the vaccine available as soon as possible.”

Added Joseph Payne, president & CEO of Arcturus: “Government agencies and foundations are securing rights and access to vaccines being developed to protect their respective populations. The Catalent Biologics team and their high-tech Madison facility is ideally suited to manufacture a substantial number of doses. Arcturus will be better positioned to supply these entities with our COVID-19 vaccine candidate on an accelerated basis with Catalent as our manufacturing partner.”