Orexo announces positive data for powder-based intranasal vaccine formulated with the AmorphOX technology
Orexo AB (ORXOY) has announced positive in-vivo proof-of-concept data for a powder-based intranasal vaccine using their AmorphOX technology. The study, conducted in partnership with Abera Bioscience, tested an influenza vaccine candidate in rats using both liquid nasal solution and intranasal powder formulations.
The results showed that both formulations successfully induced strong systemic antibody response in serum (IgG) and locally in the nose and lungs (IgA), with no difference in immune response between the two delivery methods. The powder formulation, utilizing AmorphOX technology, offers potential advantages including cost-efficiency and thermostability without cold chain requirements.
This development represents a significant milestone in vaccine delivery innovation, particularly relevant for pandemic scenarios, as powder-based vaccines could enable simplified logistics and potential self-administration during mass vaccination campaigns.
Orexo AB (ORXOY) ha annunciato dati positivi di prova di concetto in-vivo per un vaccino intranasale a base di polvere utilizzando la loro tecnologia AmorphOX. Lo studio, condotto in collaborazione con Abera Bioscience, ha testato un candidato vaccinale contro l'influenza in ratti utilizzando sia una soluzione nasale liquida che formulazioni in polvere intranasali.
I risultati hanno mostrato che entrambe le formulazioni hanno indotto con successo una forte risposta anticorpale sistemica nel siero (IgG) e localmente nel naso e nei polmoni (IgA), senza differenze nella risposta immunitaria tra i due metodi di somministrazione. La formulazione in polvere, che utilizza la tecnologia AmorphOX, offre vantaggi potenziali tra cui efficienza dei costi e termostabilità senza necessità di catena del freddo.
Questo sviluppo rappresenta una pietra miliare significativa nell'innovazione nella somministrazione dei vaccini, particolarmente rilevante per scenari pandemici, poiché i vaccini a base di polvere potrebbero semplificare la logistica e consentire potenzialmente l'auto-somministrazione durante le campagne di vaccinazione di massa.
Orexo AB (ORXOY) ha anunciado datos positivos de prueba de concepto in-vivo para una vacuna intranasal a base de polvo utilizando su tecnología AmorphOX. El estudio, realizado en colaboración con Abera Bioscience, probó un candidato a vacuna contra la influenza en ratas utilizando tanto una solución nasal líquida como formulaciones en polvo intranasales.
Los resultados mostraron que ambas formulaciones indujeron con éxito una fuerte respuesta de anticuerpos sistémicos en suero (IgG) y localmente en la nariz y los pulmones (IgA), sin diferencias en la respuesta inmunitaria entre los dos métodos de administración. La formulación en polvo, que utiliza la tecnología AmorphOX, ofrece ventajas potenciales que incluyen eficiencia de costos y termostabilidad sin requisitos de cadena de frío.
Este desarrollo representa un hito significativo en la innovación de la entrega de vacunas, especialmente relevante para escenarios pandémicos, ya que las vacunas a base de polvo podrían permitir una logística simplificada y una posible auto-administración durante las campañas de vacunación masiva.
Orexo AB (ORXOY)는 AmorphOX 기술을 사용한 분말 기반의 비강 백신에 대한 긍정적인 생체 내 개념 증명 데이터를 발표했습니다. Abera Bioscience와 협력하여 실시된 이 연구는 액체 비강 용액과 비강 분말 제형을 사용하여 쥐에서 인플루엔자 백신 후보를 테스트했습니다.
결과는 두 제형 모두 혈청에서 강력한 전신 항체 반응(IgG)과 코 및 폐에서 국소적으로(IgA) 성공적으로 유도했으며, 두 전달 방법 간의 면역 반응에는 차이가 없음을 보여주었습니다. AmorphOX 기술을 활용한 분말 제형은 비용 효율성과 냉장 유통 필요 없이 열 안정성을 포함한 잠재적인 이점을 제공합니다.
이 개발은 백신 전달 혁신에서 중요한 이정표를 나타내며, 특히 팬데믹 시나리오에 적합합니다. 분말 기반 백신은 물류를 단순화하고 대규모 백신 접종 캠페인 중 자가 투여를 가능하게 할 수 있습니다.
Orexo AB (ORXOY) a annoncé des données positives de preuve de concept in-vivo pour un vaccin intranasal à base de poudre utilisant leur technologie AmorphOX. L'étude, réalisée en partenariat avec Abera Bioscience, a testé un candidat vaccin contre la grippe chez des rats en utilisant à la fois une solution nasale liquide et des formulations en poudre intranasales.
Les résultats ont montré que les deux formulations induisaient avec succès une forte réponse anticorps systémique dans le sérum (IgG) et localement dans le nez et les poumons (IgA), sans différence dans la réponse immunitaire entre les deux méthodes d'administration. La formulation en poudre, utilisant la technologie AmorphOX, offre des avantages potentiels tels que l'efficacité des coûts et la thermostabilité sans exigences de chaîne du froid.
Ce développement représente une étape importante dans l'innovation de la délivrance des vaccins, particulièrement pertinente pour les scénarios pandémiques, car les vaccins à base de poudre pourraient permettre une logistique simplifiée et une auto-administration potentielle lors des campagnes de vaccination de masse.
Orexo AB (ORXOY) hat positive In-vivo-Daten zur Machbarkeit eines pulverbasierten intranasalen Impfstoffs unter Verwendung ihrer AmorphOX-Technologie bekannt gegeben. Die Studie, die in Zusammenarbeit mit Abera Bioscience durchgeführt wurde, testete einen Influenza-Impfstoffkandidaten bei Ratten mit sowohl flüssiger Nasenlösung als auch intranasalen Pulverformulierungen.
Die Ergebnisse zeigten, dass beide Formulierungen erfolgreich eine starke systemische Antikörperreaktion im Serum (IgG) und lokal in der Nase und in der Lunge (IgA) induzierten, ohne Unterschiede in der Immunantwort zwischen den beiden Verabreichungsmethoden. Die Pulverformulierung, die die AmorphOX-Technologie nutzt, bietet potenzielle Vorteile wie Kosteneffizienz und Thermostabilität ohne Kühlkettenanforderungen.
Diese Entwicklung stellt einen bedeutenden Meilenstein in der Impfstoffabgabe-Innovation dar, die insbesondere für pandemische Szenarien relevant ist, da pulverbasierte Impfstoffe eine vereinfachte Logistik und potenzielle Selbstverabreichung während Massenimpfkampagnen ermöglichen könnten.
- Successful proof-of-concept data showing effective vaccine delivery
- Powder formulation performs equally well as traditional liquid delivery
- Technology eliminates cold chain requirements, reducing costs
- Potential for simplified logistics and self-administration in mass vaccination
- Study to early-stage animal testing only
- Results yet to be validated in human trials
- The study was conducted in partnership with Abera Bioscience, a platform and vaccine developer with over 30 years of research in the medical, molecular and microbiological fields.
- Both formulations tested induced strong systemic antibody response in serum (IgG) as well as locally in the nose and lungs (IgA).
- The collaboration is in line with Orexo's strategy to broaden the use of its powder-based drug delivery technology, AmorphOX®.
UPPSALA,
The data was generated under the collaboration between Orexo and Abera Biosciences ("Abera") entered in December 2024. The aim of the collaboration is to develop mucosal vaccines by combining Orexo's powder-based drug delivery technology AmorphOX with Abera's innovative and patented vaccine platform BERA™.
The proof-of-concept study was conducted in rats where Abera's influenza vaccine candidate was administered intranasally, either formulated as a liquid nasal solution or as an intranasal powder using Orexo's AmorphOX technology. Both formulations induced strong systemic antibody response in serum (IgG) as well as locally in the nose and lungs (IgA). No difference in immune response was seen between the liquid nasal solution and the intranasal powder.
An intranasal influenza vaccine has the potential to easily and effectively help reduce the spread of infections and prevent disease, which could play an important role in a potential future pandemic. Formulating vaccines in powder form using the AmorphOX technology provides the potential to develop cost-efficient, thermostable vaccines with no need for cold chain requirements.
Robert Rönn, SVP and Head of R&D, comments: "We are pleased by these results providing us with important proof-of-concept data for a vaccine formulated in our proprietary powder-based drug delivery technology AmorphOX. The potential benefits from formulating vaccines in powder form are significant, as they can reach so many more patients worldwide. The study results represent an important milestone in our continued efforts to develop new and innovative drugs."
"It is very encouraging to see that our vaccines perform well in both liquid and powder forms. Powder formulations offer significant advantages in future pandemic scenarios, particularly in terms of simplified logistics, thermal stability, and the potential for self-administration during mass vaccination campaigns. Orexo's AmorphOX technology is an innovative platform that appears to preserve the immunogenic properties of our vaccine," says Mats Lundgren, CSO of Abera Bioscience.
For further information contact:
Nikolaj Sørensen, President and CEO
Lena Wange, IR & Communications Director
Robert Rönn, SVP and Head of R&D
Tel: +46 (0)18 780 88 00
E-mail: ir@orexo.com
About Orexo
Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs.
On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2024 amounted to
For more information on Orexo, visit www.orexo.com. Follow Orexo on X, LinkedIn, and YouTube.
About AmorphOX®
Orexo's proprietary drug delivery platform, AmorphOX, is a powder made up of particles that
are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure.
About Abera Bioscience
Abera Bioscience AB is a Swedish vaccine and biotechnology company founded in 2012, originating from molecular biology research at Vrije Universiteit Amsterdam and
For more information on Orexo, www.aberabio.com.
About BERA™
Abera's BERA™ vaccine platform is based on bacterial particles known as OMVs (Outer Membrane Vesicles), which are decorated with a large number of disease-specific antigens. Vaccines based on the BERA platform can be administered as nasal sprays and create protection in both mucosal membranes and systemically in the body, aiming to protect against both disease and transmission. The platform technology that enables the rapid development of new vaccine candidates as antigens can be replaced in a plug-and-play manner.
The information was submitted for publication at 8.00 am CET on April 10, 2025.
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SOURCE Orexo
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