Uppsala-based pharmaceutical company Orexo AB (publ.) (STO: ORX) (OTCQX: ORXOY) and SVF Vaccines AB have announced a research collaboration to investigate whether Orexo's proprietary powder-based drug delivery technology, AmorphOX, can be used to develop stable powder-based formulations of lipid nanoparticle (LNP)-encapsulated messenger RNA (mRNA) vaccines.

Project assessment and vaccine development

The project will assess whether LNP-mRNA formulations can be formulated and spray dried using AmorphOX while preserving critical nanoparticle properties and functional mRNA activity.

It combines Orexo's expertise in powder formulation and intranasal drug delivery with SVF Vaccines' expertise in vaccine development.

Addressing formulation challenges

According to the announcement, LNPs protect mRNA and enable its delivery into cells.

However, maintaining the stability of both the mRNA and its lipid carrier presents formulation challenges that can complicate storage and distribution. LNP-mRNA formulations often require cold-chain storage and transportation.

Powder-based formulations could help address these challenges and allow more flexible handling, transport, and storage and could reduce cold-chain requirements, simplify handling and distribution, and help broaden access to future mRNA-based products.

Positive results from the collaboration could support further development of powder-based mRNA vaccines with improved storage, distribution, and handling characteristics, including potential needle-free intranasal applications.

If successful, the initial program could support further development toward intranasal administration, which would require additional evaluation of delivery performance, tolerability, and mucosal immune responses.

Executive commentary

"This collaboration will explore whether AmorphOX can address an important formulation challenge in mRNA vaccine development," said Nikolaj Sørensen, President and CEO at Orexo AB. "Our initial objective is to establish whether we can develop stable powder-based formulations while preserving LNP integrity and mRNA activity. Positive results would provide a foundation for further development and help us assess the potential of our technology in vaccines and other biologic applications."

Matti Sällberg, Founder and Chief Scientific Officer of SVF Vaccines, commented that the clinical success of mRNA vaccines has highlighted both the enormous promise and the formulation challenges associated with these technologies.

He said the ability to convert LNP-mRNA formulations into a stable dry powder suitable for nasal administration could represent an important advancement for the field, noting that intranasal vaccination offers an opportunity to generate immunity where respiratory pathogens enter the body.

He described the collaboration as an important first step toward exploring how SVF Vaccines' mRNA vaccine expertise and Orexo's formulation capabilities could support that goal.

Strategic context

The collaboration forms part of Orexo's strategy to evaluate AmorphOX across additional therapeutic areas and molecule classes.

Results from the initial feasibility program will inform decisions on subsequent development and potential expansion of the collaboration.

About the technologies

Messenger RNA (mRNA) carries instructions that cells use to produce proteins. In vaccines, mRNA instructs cells to produce an antigen that helps the immune system recognize and respond to a specific pathogen.

Lipid nanoparticles are tiny particles made from lipids that protect mRNA from degradation and facilitate its delivery into cells, making them a key component of mRNA vaccines and therapeutics.

AmorphOX is a proprietary drug delivery technology at the core of Orexo's innovation that improves bioavailability and stability for both large and small molecules, enabling new approaches to administration, manufacturing, and distribution.

About the companies

SVF Vaccines is a clinical-stage biotechnology company focused on the discovery and development of innovative vaccines and immunotherapies targeting serious viral infections.

The company's pipeline is built on proprietary antigen design strategies that aim to induce both potent neutralizing antibody responses and durable T-cell immunity. It has extensive expertise in immunology, virology, and translational medicine to advance next-generation vaccine technologies addressing significant unmet medical needs.

Orexo is a Swedish pharmaceutical company dedicated to advancing treatments for severe diseases and life-saving rescue medications to meet future healthcare needs.

With over 30 years of experience and multiple drugs approved globally, Orexo is advancing a diversified pipeline of programs in clinical and preclinical development and collaborates with partners in research, development, and commercialization.

Headquartered in Uppsala, Sweden, the company is listed on Nasdaq Stockholm's main market and trades as ADRs on the OTCQX market in the United States.

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