Arcturus Therapeutics & Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine

Arcturus Therapeutics Holdings Inc. and Catalent, Inc.recently 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 company’s LUNAR lipid-mediated delivery to produce an extraordinarily low dose, potential single shot COVID-19 vaccine.

The manufacture of LUNAR-COV19 at Catalent’s state-of-the-art drug substance biomanufacturing facility in Madison, WI, 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 100s of millions of doses annually for worldwide use. Preparations for this program have already begun at the Madison facility, and both organizations 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, Chair and Chief Executive Officer 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.”

Joseph Payne, President & CEO of Arcturus, added “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.”

Founded in 2013 and based in San Diego, CA, Arcturus Therapeutics Holdings Inc. is a clinical-stage mRNA medicines and vaccines company with enabling technologies: LUNAR lipid-mediated delivery, STARR mRNA Technology, and mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic candidates includes programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Glycogen Storage Disease Type 3, Hepatitis B, non-alcoholic steatohepatitis (NASH) and a self-replicating mRNA vaccine for SARS-CoV-2. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (187 patents and patent applications, issued in the US, Europe, Japan, China, and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS, and the Cystic Fibrosis Foundation. For more information, visit www.ArcturusRx.com

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx cell line development technology, and 35+ commercially approved products. Catalent has recently acquired MaSTherCell, a technology-focused cell therapy development and manufacturing partner with expertise in autologous and allogeneic cell therapy that complements Catalent’s industry-leading expertise and commercial success in gene therapy development, manufacturing and adeno-associated virus (AAV) vector production. Together, Paragon Gene Therapy and MaSTherCell have produced over 100 GMP batches across 60+ clinical and commercial programs. For more information, visit www.catalent.com/biologics