Collaboration expands Aldevron’s capabilities in mRNA lipid nanoparticle encapsulation

Aldevron, a leading global manufacturer of DNA, RNA, and proteins used in cell and gene therapies and vaccine development, today announced it has entered a strategic partnership with Acuitas Therapeutics, Inc., a private biotechnology company specializing in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles (LNPs). This partnership will allow Aldevron to expand its capabilities in mRNA LNP encapsulation by incorporating Acuitas’ proprietary LNP encapsulation platform, increasing Aldevron’s services and capabilities as an mRNA sequence-to-vial custom manufacturer.

In May of 2023, Aldevron announced the expansion of its mRNA production capabilities to include Cytiva’s mRNA LNP encapsulation and aseptic fill-finish platform. This new strategic partnership with Acuitas Therapeutics, working with its encapsulation platform, equips Aldevron with a diverse range of mRNA LNP technologies, significantly enhancing its mRNA end-to-end drug product service capabilities. The partnership will enable Aldevron to support Acuitas’ LNP formulations and licensees.

“This collaboration with Acuitas is an exciting addition to our existing mRNA sequence-to-vial services and will enable Acuitas partners to leverage Aldevron’s extensive mRNA manufacturing experience and comprehensive end-to-end capabilities,” said Mark Wetzel, Vice President mRNA CDMO at Aldevron. “We look forward to our continued partnership that is poised to enhance the landscape of mRNA-based therapies, bringing faster timelines and hope, to patients worldwide.”

“We have long known of Aldevron’s reputation and broad experience in the manufacturing of nucleic acids and their commitment to quality,” said Chris Barbosa, Vice President of Technology Development at Acuitas Therapeutics, Inc. “We are pleased to work with Aldevron to provide Acuitas partners with an integrated path to clinical drug products using Acuitas’ lipid nanoparticle manufacturing processes.” He added, “We look forward to Aldevron’s contribution to working with us to support our global partners in bringing new mRNA-based therapies to patients as quickly and efficiently as possible.”

“The Acuitas technology, combined with Aldevron’s extensive experience providing cutting-edge solutions for advancing therapies and rigorous quality processes, provides an exceptional advantage,” continued Wetzel. “With our two decades of experience in mRNA technologies, Aldevron has developed a seamless workflow from mRNA sequence-to-vial, and this partnership provides clients LNP platform flexibility for the appropriate development stage for their program.”

About Aldevron

Aldevron is a premier manufacturing partner, producing high-quality plasmid DNA, mRNA, proteins, and other key components for the development of vaccines, gene and cell therapies, immunotherapies, and molecular diagnostics. Headquartered in Fargo, North Dakota, with additional locations in Madison, Wisconsin, and Lincoln, Nebraska, Aldevron supports scientists who are developing revolutionary, lifesaving treatments for millions of people. To learn more about how Aldevron is advancing biological science, visit https://www.aldevron.com.

About Acuitas

Vancouver-based Acuitas Therapeutics (www.acuitastx.com) partners with pharmaceutical and biotechnology companies, as well as non-governmental organizations and academic institutes, to advance nucleic acid therapeutics into clinical development and commercialization. Acuitas’ lipid nanoparticle (LNP) technology is clinically validated, enabling Alnylam Pharmaceuticals’ ONPATTRO® for the treatment of people with a rare genetic and otherwise fatal disorder known as transthyretin amyloidosis and the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY®, which has protected billions of people in more than 180 countries. Acuitas has also helped to enable the first human proof-of-concept for genome base editing to treat a serious genetic disease. The company is currently focused on further innovations to its LNP carriers to advance the development of novel gene therapies, such as epigenetic medicines, to modulate gene expression without genetic editing to treat a range of diseases, including cancer. In addition, Acuitas works with partners on the development of improved vaccines – such as multi-valent vaccines to prevent a range of infectious diseases (including malaria, HIV/AIDS and tuberculosis) – and on novel therapeutic vaccines against cancer, including personalized cancer vaccines.

Alderon Contact: Ellen Shafer Senior Director of Communications ellen.shafer@aldevron.com 701-551-8704

Acuitas Contact: Ruth Atherley Communications ratherley@acuitastx.com 604-787-7379