Biovectra to undertake tech transfer for Acuitas LNP platform

Biovectra will use Acuitas Therapeutics’ LNP platform to manufacture mRNA-based therapeutics at its facility in Atlantic Canada.

Under the terms of the deal, contract development manufacturing organization (CDMO) Biovectra said it will accept, on a non-exclusive basis, Acuitas’ lipid nano-particle (LNP) technology platform to produce messenger RNA (mRNA)-based therapeutics.

“While it is policy not to disclose financial information, what we can tell you is that both parties have invested to transfer the technology and establish manufacturing processes at Biovectra. This included procurement of equipment, multiple formulation runs, and transfer of analytical methods,” Jessica Madigan, director, business development, Nucleic Acid Modalities at Biovectra, told us.

The CDMO will create LNPs for Acuitas’ therapeutic partners for both clinical and commercial products using various payloads. Biovectra will conduct this work at its biomanufacturing center in Charlottetown, Canada, which is set to be complete later this year and will support GMP production of plasmid DNA (pDNA), mRNA, and LNP formulations.

“The initial agreement is 5 years with optional renewal,” said Madigan.

DepositPhotos/MaksLab

The firm said the addition of 36,000 square feet to its existing Charlottetown campus will enable production of 160 million doses of mRNA vaccines and the ability to fill/finish 70 million final vaccine doses per year for commercial distribution.

“We are thrilled about this partnership with Acuitas Therapeutics, a global leader in LNP delivery systems,” stated Marc Sauer, 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.”

In January 2022, Pfizer announced it had access on a non-exclusive bases to Acuitas’ LNP technology delivery system to develop up to ten targets for potential mRNA vaccines or therapeutics. Additionally, the platform was used for Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty, which received regulatory approval in December 2020.

“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 Chris Barbosa, vice president, Technology Development, Acuitas.

“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.”