Unlocking the Potential of AmorphOX® in Vaccines

Expanding the Use of the AmorphOX^® Technology into Vaccines

From her office in the U.S., Lisa Moore is leading Orexo’s product and portfolio strategy. She has a successful career in the pharmaceutical industry across marketing, new product planning, strategy, and commercialization. At Orexo’s R&D Day on March 24th, Lisa had a central role presenting the strategy to expand the use of AmorphOX into new areas such as GLP-1 agonists and vaccines.

Lisa, at the R&D Day you talked about the potential to use the AmorphOX technology in vaccines. Can you summarize why this is an exciting opportunity?

AmorphOX has the potential to transform vaccination by enabling thermostable, needle-free intranasal vaccines that are easier to distribute globally and less reliant on cold-chain infrastructure. By combining dry-powder stability with administration beyond traditional healthcare settings, the technology could expand vaccine access, improve vaccination rates, and reduce healthcare, distribution, and storage costs. In addition, by inducing strong mucosal immunity in the nose, at the site where many respiratory infections begin, it may help prevent the initial infection in the lungs and upper airway and reduce infectious disease transmission rates, improving outbreak control. Together, these benefits create a compelling opportunity to deliver value for patients, healthcare systems, and vaccine manufacturers, while strengthening preparedness for future public health threats.

AmorphOX has the potential to transform vaccination by enabling thermostable, needle-free intranasal vaccines that are easier to distribute globally and less reliant on cold-chain infrastructure.

Use of nasal delivery for vaccines is not widely used today. Why do you think AmorphOX can change that?

One reason intranasal vaccines have not been widely adopted is that developers have historically faced challenges with vaccine stability, distribution logistics, and achieving the right balance of efficacy and ease of use. Traditional liquid intranasal vaccines have stability issues and require refrigeration to maintain potency, and temperature excursions during shipping, storage, and handling can compromise the product. Furthermore, some liquid intranasal vaccines have shown variability in absorption and efficacy, with inconsistent vaccine performance between individuals. AmorphOX may help overcome these barriers by enabling thermostable vaccine formulations that can remain stable without extensive cold-chain infrastructure, making vaccines easier and less costly to distribute. The technology could ease distribution for mail-order and at-home vaccination, significantly improving convenience and access. From an efficacy standpoint, AmorphOX formulated vaccines may provide rapid absorption, low variability, and consistent deposition and dissolution of the powder in the nasal mucosa, potentially leading to more dependable and reproducible results.

Will a nasally delivered AmorphOX vaccine provide the same immune protection as an injectable vaccine? 

Based on the data generated to date, the answer appears to be yes. An intranasal vaccine formulated with AmorphOX has the potential to provide immune protection comparable to a more traditional vaccine formulation, although this still needs to be confirmed in human studies. In Orexo's collaboration with Abera Bioscience, a preclinical influenza vaccine study showed that the AmorphOX intranasal powder formulation generated strong systemic antibody responses (IgG) as well as local mucosal antibody responses (IgA) in the nose. What makes the nasal approach particularly interesting is that it may provide an additional layer of protection by stimulating mucosal immunity, which injectable vaccines often induce less effectively. Mucosal antibodies in the nose may help prevent infection at the point of entry and potentially reduce transmission of infectious diseases.

What has happened since the R&D Day in March? Has Orexo made any progress in vaccines?

Since the R&D Day in March, we have continued to advance our understanding of how AmorphOX could be applied to vaccines and have further strengthened the scientific rationale for this opportunity. We have initial collaborations with leading U.S. and Swedish vaccine research institutions to test the AmorphOX platform and together are exploring external non-dilutive funding for vaccine development. Discussions have ensued to evaluate the effect of formulating various types of experimental and commercially available vaccines – mRNA, DNA, and live attenuated virus vaccines – with AmorphOX, measuring the vaccines’ viability, stability, and immunogenicity.

In May, we held a meeting with the Biomedical Advanced Research and Development Authority (BARDA) TechWatch Team to discuss the AmorphOX technology and potential applications enabling thermostable powder-based vaccines and protein biologics. More than 60 U.S. government personnel attended, including representatives from BARDA, NIH, IBMSC, ARPA-H, DTRA, and the DoW. The meeting also introduced potential non-dilutive government funding pathways for AmorphOX vaccine development. Other vaccine partnership and feasibility testing discussions with vaccine manufacturers are ongoing, focused on next-generation vaccine technologies. These efforts are helping us expand the evidence base around AmorphOX and its potential role in enabling more stable and accessible vaccines.

From an investor’s perspective, what are the key value inflections to watch?

The Abera collaboration has generated encouraging preclinical vaccine data, but human data will be important to build credibility and would represent a major step-change in value. Progression to funded vaccine studies, government contracts, or strategic vaccine partnerships, whether with an industry player or research institution, would also provide important proof points and additional external validation. Investors should also look for evidence that AmorphOX can successfully formulate other molecules and secure regulatory approval as platform validation. This would shift the investment thesis from a single product story to a platform story, demonstrating success across multiple products and therapeutic areas.

Progression to funded vaccine studies, government contracts, or strategic vaccine partnerships, whether with an industry player or research institution, would also provide important proof points and additional external validation.