Partnership between two Canadian life sciences leaders offers a commercial GMP manufacturing solution for Acuitas’ licensed partners developing promising next generation therapies

BIOVECTRA and Acuitas Therapeutics, Inc. today announced that they have entered into a technology transfer service agreement under which BIOVECTRA will accept, on a non-exclusive basis, Acuitas’ best-in-class LNP technology platform for manufacturing mRNA-based therapeutics.

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“We are thrilled about this partnership with Acuitas Therapeutics, a global leader in LNP delivery systems,” stated Marc Sauer, Ph.D., Chief Science Officer, BIOVECTRA. “Our work together will provide their licensed partners with faster market access to cGMP-quality LNPs for early and late-stage products. BIOVECTRA looks forward to continuing to make a difference in patients’ lives by supporting GMP and commercial-ready LNP formulation at our new mRNA biomanufacturing facility in Atlantic Canada.”

Through this partnership, BIOVECTRA will formulate Acuitas’ LNP for licensed therapeutic partners for clinical and commercial products using a variety of payloads. Acuitas’ proprietary LNP technology is used in multiple vaccines and therapeutics in clinical development and enables COMIRNATY®, the Pfizer-BioNTech COVID-19 vaccine that was first to receive regulatory approval and that has been administered to people in 180 countries.

“LNP-based mRNA medicines provide the opportunity to address an incredibly wide range of health conditions, from infectious diseases such as COVID-19, flu, and malaria to therapeutic areas related to heart disease, or cancer, as well as many rare diseases,” said Dr. Chris Barbosa, Vice President, Technology Development, Acuitas Therapeutics. He added: “As we move forward in the development process in all of these areas with our partners, the demand for Acuitas’ clinical-grade LNP for our partners increases exponentially. We look forward to working with the BIOVECTRA team to expand the cGMP manufacturing capacity for Acuitas’ LNP so that we can continue to meet the growing needs of our global partners.”

The work will occur in BIOVECTRA’s new biomanufacturing centre, which, upon completion later this year, will support the GMP manufacturing of plasmid DNA, mRNA and LNP formulations. This facility adds 36,000 square feet to BIOVECTRA’s existing Charlottetown campus and will be able to produce the equivalent of 160 million doses of mRNA vaccines and to fill/finish 70 million final vaccine doses per year for commercial distribution, providing an end-to-end manufacturing solution for BIOVECTRA’s clients. Currently, BIOVECTRA is fully equipped and staffed with a team of experts at bench scale, to begin the technical transfer of nucleic acid processes that will be destined for manufacture in these new facilities. It also carries a deep track record of GMP commercial supply of lipids (including custom ionizable lipids), complex API’s and drug substances, from its five GMP facilities in Eastern Canada.

About BIOVECTRA

BIOVECTRA (www.biovectra.com) is a global biotech and pharmaceutical CDMO (contract development and manufacturing organization) that specializes in clinical-to-commercial scale production capabilities for: biologics, small molecules, bioreagents, lipids, pDNA, mRNA and LNP manufacturing. Flexibility, creativity, process optimization and compliance are at the heart of our method. With more than 50 years of experience, over 600 employees, and cGMP facilities in Prince Edward Island and Nova Scotia, Canada, we assure our programs advance on time and with the highest quality outcomes.

About Acuitas Therapeutics

Vancouver-based Acuitas Therapeutics (www.acuitastx.com) is a private biotechnology company specializing in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles. Acuitas partners with pharmaceutical and biotechnology companies, as well as non-governmental organizations and academic institutes, to advance nucleic acid therapeutics into clinical trials and the marketplace. The team works with global partners to develop new therapies to address unmet clinical needs based on the internationally recognized capabilities of its proprietary delivery technology. Acuitas Therapeutics’ lipid nanoparticle technology is used in the Pfizer-BioNTech COVID-19 vaccine COMIRNATY®. The Acuitas team is currently working on therapeutics focused on addressing cancer, HIV/AIDS, tuberculosis, malaria and other serious diseases.

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@BIOVECTRA Signs Service Agreement with Acuitas Therapeutics for Unique Lipid Nanoparticle Delivery System Used in Manufacturing mRNA-Based Therapies