- Arcturus Therapeutics has entered a strategic collaboration with Thermo Fisher Scientific to support the Phase 3 development and potential commercialization of its investigational mRNA therapy, ARCT-032, for cystic fibrosis.
- Thermo Fisher will provide integrated manufacturing, clinical research, and commercial readiness services, with exclusive commercial manufacturing rights if ARCT-032 receives regulatory approval.
Arcturus Therapeutics Holdings Inc. has entered into a strategic collaboration with Thermo Fisher Scientific to support the Phase 3 development and potential commercialization of ARCT-032, its investigational mRNA therapy for cystic fibrosis. The collaboration will utilize Thermo Fisher’s Accelerator™ Drug Development solutions to provide integrated manufacturing, clinical research, and commercial readiness services.
Under the agreement, Thermo Fisher will provide Phase 3 manufacturing, clinical research, and related services to support the development of ARCT-032. If Phase 2 results are positive, Arcturus plans to conduct its Phase 3 clinical program through Thermo Fisher’s PPD™ clinical research business. Subject to regulatory approval, Thermo Fisher will receive exclusive commercial manufacturing rights under a separate commercial agreement.
The companies said the collaboration combines Thermo Fisher’s global infrastructure and CDMO capabilities with Arcturus’ mRNA development program to support progression from late-stage clinical development through potential commercial supply. The agreement is intended to streamline development while reducing operational complexity.
“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.”
Joseph Payne, President and Chief Executive Officer of Arcturus Therapeutics
According to the companies, the collaboration is focused on supporting the continued development of ARCT-032 while preparing for potential commercialization through integrated contract manufacturing and clinical research services.
