Arcturus Therapeutics Announces Strategic Collaboration with Thermo Fisher Scientific

The partnership will support the Phase 3 development and potential commercial launch of ARCT-032, Arcturus' investigational mRNA therapy for cystic fibrosis.

Under the collaboration, Thermo Fisher Scientific will provide manufacturing, clinical research, and commercial support through its Accelerator™ Drug Development platform. These services are intended to help speed the Phase 3 development of ARCT-032 and prepare the therapy for potential commercialization. Arcturus will continue leading the development of ARCT-032 while working with Thermo Fisher to advance the program.

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Under the agreement, Thermo Fisher will provide manufacturing, clinical research, and other support services for the Phase 3 program. If the Phase 2 trial is successful, Arcturus plans to conduct the Phase 3 study through Thermo Fisher's PPD™ clinical research business.

If ARCT-032 receives regulatory approval, Thermo Fisher will become the exclusive commercial manufacturing partner under a separate commercial agreement.

“We are pleased to collaborate with Thermo Fisher to utilize its impressive CDMO capabilities, global infrastructure, and proven ability to support complex mRNA programs from Phase 3 through potential commercialization,” said Joseph Payne, President and Chief Executive Officer of Arcturus Therapeutics. “Their capabilities are aligned with Arcturus’ goal of efficiently advancing our cystic fibrosis program into Phase 3 and preparing for potential commercial supply.”

“Biotechnology innovators increasingly seek strategic collaborators that can support complex development programs across clinical and commercial stages,” said Mike Shafer, Executive Vice President and President, Biopharma Services, Thermo Fisher Scientific. “Through Accelerator™ Drug Development, Thermo Fisher brings together manufacturing, clinical research, and commercialization expertise to help customers simplify development, reduce operational complexity, and accelerate the delivery of innovative therapies to patients.

About Arcturus

Founded in 2013 by Padmanabh Chivukula and based in San Diego, California, Arcturus Therapeutics Holdings Inc. is a biotechnology company developing messenger RNA (mRNA) medicines for rare liver and respiratory diseases. Its technology platform includes LUNAR® lipid delivery, STARR® self-amplifying mRNA (sa-mRNA) technology, and in-house mRNA manufacturing capabilities.

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