Arcturus Therapeutics and Thermo Fisher Scientific Form Strategic Collaboration to Advance ARCT-032 for Cystic Fibrosis Through Phase 3 Development and Potential Commercialization
Arcturus Therapeutics Holdings Inc., a clinical-stage messenger RNA (mRNA) medicines company focused on developing innovative therapies for liver and respiratory rare diseases, has announced a strategic collaboration with Thermo Fisher Scientific to support the late-stage clinical development and potential commercialization of ARCT-032, the company’s investigational mRNA therapy for cystic fibrosis (CF).
The partnership brings together Arcturus’ expertise in mRNA therapeutics with Thermo Fisher Scientific’s extensive capabilities in biopharmaceutical manufacturing, clinical research, and commercialization support. Through the collaboration, the companies aim to streamline the transition of ARCT-032 from clinical development into potential commercial production, should the therapy ultimately receive regulatory approval.
The agreement represents an important milestone for Arcturus as it prepares for the next phase of clinical development for one of its most advanced pipeline candidates, while highlighting the growing role of integrated development partnerships in accelerating the delivery of innovative medicines to patients with serious diseases.
Supporting the Development of an Investigational mRNA Therapy
Under the terms of the collaboration, Thermo Fisher Scientific will provide a comprehensive suite of services designed to support the continued advancement of ARCT-032 through Phase 3 clinical development and potential commercialization.
The collaboration will utilize Thermo Fisher’s Accelerator™ Drug Development platform, an integrated offering that combines contract development and manufacturing (CDMO), clinical research, regulatory support, and commercial manufacturing services under a unified development model.
By bringing these capabilities together, the companies aim to simplify operational complexity, improve development efficiency, and ensure manufacturing readiness as ARCT-032 progresses through the final stages of clinical evaluation.
The integrated approach is intended to reduce the challenges often associated with coordinating multiple external partners during late-stage drug development while supporting continuity throughout the product lifecycle.
Focus on ARCT-032 for Cystic Fibrosis
ARCT-032 is an investigational messenger RNA therapy being developed as a potential treatment for cystic fibrosis, a serious inherited disease that primarily affects the lungs and digestive system.
Unlike conventional therapies that target specific mutations or manage symptoms, ARCT-032 is designed to deliver messenger RNA encoding functional cystic fibrosis transmembrane conductance regulator (CFTR) protein, with the goal of restoring normal protein production within affected cells.
Messenger RNA therapies represent an emerging therapeutic approach that enables cells to temporarily produce functional proteins without permanently altering a patient’s DNA.
Arcturus has focused its research efforts on developing proprietary mRNA technologies capable of delivering therapeutic proteins directly to target tissues, including the respiratory system.
The company’s respiratory disease platform seeks to address significant unmet medical needs among patients living with rare pulmonary disorders.
Preparing for Phase 3 Development
The newly announced collaboration comes as Arcturus continues advancing ARCT-032 toward late-stage clinical testing.
According to the agreement, Thermo Fisher will provide manufacturing support for Phase 3 clinical supplies while also delivering related development services necessary to prepare the investigational therapy for pivotal clinical evaluation.
Should ongoing Phase 2 studies generate positive results, Arcturus intends to conduct its Phase 3 clinical program utilizing Thermo Fisher’s PPD™ clinical research business, one of the world’s largest providers of clinical research services.
This integrated model allows manufacturing, clinical operations, and commercialization planning to be coordinated through a single strategic partner, helping reduce delays that can occur during transitions between development stages.
Leveraging Thermo Fisher’s Global Infrastructure
Thermo Fisher Scientific brings extensive global capabilities in pharmaceutical development, manufacturing, and clinical research to the collaboration.
Its worldwide network of manufacturing facilities, regulatory expertise, and clinical research infrastructure has supported numerous biotechnology and pharmaceutical companies across a broad range of therapeutic areas.
Through the Accelerator™ Drug Development platform, Thermo Fisher integrates multiple services that traditionally would require coordination among separate organizations.
These services include process development, analytical testing, manufacturing, clinical trial management, regulatory support, supply chain planning, and commercial readiness activities.
For emerging biotechnology companies such as Arcturus, access to this comprehensive infrastructure can help accelerate product development while reducing operational complexity.
Commercial Manufacturing Plans
Beyond supporting clinical development, the agreement also establishes a framework for future commercial manufacturing.
Subject to successful clinical outcomes and regulatory approval of ARCT-032, Thermo Fisher will receive exclusive commercial manufacturing rights under a separate commercial manufacturing agreement.
This forward-looking arrangement enables both companies to begin planning commercial-scale production well before potential regulatory approval, reducing the time required to transition from clinical development to market availability.
Establishing commercial manufacturing plans early in development has become increasingly important for advanced biologic and mRNA therapies, where production processes often require specialized expertise and sophisticated manufacturing infrastructure.
Executive Perspective from Arcturus
Joseph Payne, President and Chief Executive Officer of Arcturus Therapeutics, described the collaboration as an important step in advancing the company’s cystic fibrosis development program.
According to Payne, Thermo Fisher’s global CDMO capabilities, manufacturing expertise, and proven experience supporting complex mRNA development programs align closely with Arcturus’ objectives for ARCT-032.
He noted that the collaboration will help position the company to efficiently advance the investigational therapy into Phase 3 clinical development while simultaneously preparing for potential future commercial supply if regulatory approvals are achieved.
Payne emphasized that partnering with an experienced global organization allows Arcturus to remain focused on advancing the scientific and clinical aspects of the program while leveraging established manufacturing and operational expertise.
Thermo Fisher Highlights Integrated Development Model
Mike Shafer, Executive Vice President and President of Biopharma Services at Thermo Fisher Scientific, noted that biotechnology companies increasingly seek strategic partners capable of supporting development programs from early clinical stages through commercialization.
He explained that Thermo Fisher’s Accelerator™ Drug Development platform was created to simplify drug development by combining manufacturing, clinical research, and commercialization expertise into a coordinated service model.
According to Shafer, integrating these capabilities helps reduce operational complexity, improve efficiency, and accelerate the delivery of innovative therapies to patients.
He added that the collaboration with Arcturus demonstrates the value of providing end-to-end support for advanced therapeutic programs, particularly those involving emerging technologies such as messenger RNA.
Growing Importance of mRNA Technologies
Messenger RNA technology has become one of the fastest-growing areas in biotechnology following significant advances in delivery systems, manufacturing processes, and clinical development over recent years.
While mRNA technology gained worldwide attention through vaccine development, researchers are now exploring its application across a wide range of diseases, including genetic disorders, rare diseases, infectious diseases, and oncology.
Companies such as Arcturus are developing specialized delivery platforms capable of transporting therapeutic mRNA molecules to specific tissues, enabling the temporary production of proteins that may correct or compensate for disease-causing genetic abnormalities.
The continued evolution of manufacturing technologies has also made large-scale production of mRNA therapeutics increasingly feasible, supporting the transition of experimental therapies into late-stage clinical development.
Addressing an Unmet Need in Cystic Fibrosis
Cystic fibrosis remains one of the most common inherited life-threatening disorders, affecting tens of thousands of individuals worldwide.
The disease is caused by mutations in the CFTR gene, resulting in defective ion transport across epithelial cells and leading to the accumulation of thick mucus in the lungs, pancreas, and other organs.
Although significant progress has been made through the development of CFTR modulator therapies, not all patients benefit equally from currently available treatments. Certain individuals possess mutations that remain difficult to treat, while others may continue to experience progressive disease despite existing therapies.
Investigational approaches such as ARCT-032 seek to address these challenges by introducing messenger RNA capable of directing cells to produce functional CFTR protein, potentially expanding treatment options for broader patient populations.
The strategic collaboration between Arcturus Therapeutics and Thermo Fisher Scientific underscores the increasing importance of integrated partnerships in advancing next-generation medicines from research through commercialization.
By combining Arcturus’ innovative mRNA platform with Thermo Fisher’s extensive manufacturing, clinical research, and commercial capabilities, the companies aim to accelerate the development of ARCT-032 while establishing the infrastructure needed for future regulatory submissions and commercial supply.
As ARCT-032 continues through clinical evaluation, the collaboration positions both organizations to efficiently support pivotal Phase 3 development and, if approved, bring a novel mRNA-based treatment option to people living with cystic fibrosis. The agreement also reflects the broader evolution of the biotechnology industry, where strategic collaborations increasingly enable innovative therapies to progress more rapidly from scientific discovery to potential patient access.
About Arcturus
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise.
Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration with CSL Seqirus, US BARDA for pandemic flu and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics.
Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA (siRNA), circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics.