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BioVaxys Developing DPX to be the Carrier of Choice for mRNA Vaccines, a market projected to grow to USD$48,000,000,000 by 2030*

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BioVaxys Technology Corp (BVAXF) is developing its DPX™ platform as an alternative to lipid nanoparticles (LNPs) for delivering mRNA vaccines. The DPX technology is a patented delivery platform that can incorporate various bioactive molecules to produce targeted, long-lasting immune responses.

Proof-of-concept studies conducted with Etherna and PCI Biotech showed that DPX provides enhanced stability of packaged mRNA, attracts specific Antigen Presenting Cells to the injection site, and induces specific immune responses. Unlike LNPs, which can cause adverse reactions and stability issues, DPX remains localized at the injection site and demonstrated stability for up to 14 days in vivo.

The company is pursuing collaborations with organizations having promising tumor and virus-specific polynucleotide antigens, positioning DPX as a potential solution in the mRNA vaccine market, which is projected to reach $48 billion by 2030.

BioVaxys Technology Corp (BVAXF) sta sviluppando la sua piattaforma DPX™ come un'alternativa alle nanoparticelle lipidiche (LNP) per la somministrazione di vaccini mRNA. La tecnologia DPX è una piattaforma di consegna brevettata che può incorporare varie molecole bioattive per produrre risposte immunitarie mirate e durature.

Studi di prova del concetto condotti con Etherna e PCI Biotech hanno dimostrato che DPX garantisce una maggiore stabilità dell'mRNA confezionato, attira specifiche cellule presentanti antigeni nel sito di iniezione e induce risposte immunitarie specifiche. A differenza delle LNP, che possono causare reazioni avverse e problemi di stabilità, DPX rimane localizzato nel sito di iniezione e ha dimostrato stabilità per un massimo di 14 giorni in vivo.

L'azienda sta perseguendo collaborazioni con organizzazioni che possiedono promettenti antigeni polinucleotidici specifici per tumori e virus, posizionando DPX come una potenziale soluzione nel mercato dei vaccini mRNA, che si prevede raggiungerà i 48 miliardi di dollari entro il 2030.

BioVaxys Technology Corp (BVAXF) está desarrollando su plataforma DPX™ como una alternativa a las nanopartículas lipídicas (LNP) para la entrega de vacunas de ARNm. La tecnología DPX es una plataforma de entrega patentada que puede incorporar diversas moléculas bioactivas para producir respuestas inmunitarias específicas y sostenidas.

Los estudios de prueba de concepto realizados con Etherna y PCI Biotech mostraron que DPX proporciona una mayor estabilidad del ARNm empaquetado, atrae células presentadoras de antígenos específicas al sitio de inyección e induce respuestas inmunitarias específicas. A diferencia de las LNP, que pueden causar reacciones adversas y problemas de estabilidad, DPX permanece localizado en el sitio de inyección y ha demostrado estabilidad de hasta 14 días en vivo.

La empresa está buscando colaboraciones con organizaciones que tengan antígenos polinucleotídicos específicos para tumores y virus prometedores, posicionando DPX como una solución potencial en el mercado de vacunas de ARNm, que se proyecta alcanzará los 48 mil millones de dólares para 2030.

BioVaxys Technology Corp (BVAXF)는 mRNA 백신 전달을 위한 대안으로 DPX™ 플랫폼을 개발하고 있습니다. DPX 기술은 다양한 생리활성 분자를 포함하여 표적화된 장기적인 면역 반응을 생성할 수 있는 특허받은 전달 플랫폼입니다.

Etherna와 PCI Biotech와 함께 진행된 개념 증명 연구는 DPX가 포장된 mRNA의 안정성을 높이고, 주사 부위에 특정 항원 제시 세포를 유도하며, 특정 면역 반응을 유도한다는 것을 보여주었습니다. LNP와는 달리, 부작용이나 안정성 문제를 일으킬 수 있는 LNP와 달리, DPX는 주사 부위에 국한되어 있으며, 최대 14일간 생체 내에서 안정성을 보였습니다.

회사는 유망한 종양 및 바이러스 특정 폴리뉴클레오타이드 항원을 보유한 조직과의 협력을 추구하고 있으며, DPX를 mRNA 백신 시장의 잠재적 솔루션으로 위치시키고 있습니다. 이 시장은 2030년까지 480억 달러에 이를 것으로 예상됩니다.

BioVaxys Technology Corp (BVAXF) développe sa plateforme DPX™ comme une alternative aux nanoparticules lipidiques (LNP) pour la livraison de vaccins à ARNm. La technologie DPX est une plateforme de livraison brevetée qui peut intégrer diverses molécules bioactives pour produire des réponses immunitaires ciblées et durables.

Les études de preuve de concept réalisées avec Etherna et PCI Biotech ont montré que DPX offre une stabilité améliorée de l'ARNm conditionné, attire des cellules présentatrices d'antigènes spécifiques sur le site d'injection et induit des réponses immunitaires spécifiques. Contrairement aux LNP, qui peuvent provoquer des réactions indésirables et des problèmes de stabilité, DPX reste localisé au site d'injection et a démontré une stabilité allant jusqu'à 14 jours in vivo.

L'entreprise poursuit des collaborations avec des organisations disposant d'antigènes polynucléotidiques spécifiques prometteurs pour les tumeurs et les virus, positionnant DPX comme une solution potentielle sur le marché des vaccins à ARNm, qui devrait atteindre 48 milliards de dollars d'ici 2030.

BioVaxys Technology Corp (BVAXF) entwickelt seine DPX™-Plattform als Alternative zu lipidbasierten Nanopartikeln (LNPs) zur Lieferung von mRNA-Impfstoffen. Die DPX-Technologie ist eine patentierte Lieferplattform, die verschiedene bioaktive Moleküle integrieren kann, um gezielte, langanhaltende Immunantworten zu erzeugen.

Machbarkeitsstudien, die mit Etherna und PCI Biotech durchgeführt wurden, zeigten, dass DPX eine verbesserte Stabilität des verpackten mRNA bietet, spezifische antigenpräsentierende Zellen an den Injektionsort anzieht und spezifische Immunantworten induziert. Im Gegensatz zu LNPs, die Nebenwirkungen und Stabilitätsprobleme verursachen können, bleibt DPX am Injektionsort lokalisiert und zeigt eine Stabilität von bis zu 14 Tagen in vivo.

Das Unternehmen verfolgt Kooperationen mit Organisationen, die vielversprechende tumor- und virus-spezifische polynucleotidartige Antigene aufweisen, und positioniert DPX als potenzielle Lösung im mRNA-Impfstoffmarkt, der bis 2030 voraussichtlich 48 Milliarden US-Dollar erreichen wird.

Positive
  • DPX platform demonstrates enhanced stability of mRNA compared to LNPs
  • Technology shows better manufacturing economics than current LNP solutions
  • Company holds multiple patents related to DPX-mRNA formulations
  • Platform demonstrates 14-day shelf-life integrity in preliminary studies
Negative
  • None.

VANCOUVER, BC, Jan. 16, 2025 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") highlights the potential for its DPX™ non-systemic immune educating platform to address the inherent limitations of lipid nanoparticles ("LNPs") for packaging and delivering mRNA and other polynucleotides. Continued development of DPX-mRNA formulations is one of the Company's objectives, with BioVaxys pursuing collaborations with companies and academic institutions that possess pipelines of promising tumor and virus-specific polynucleotide antigens.

 

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BioVaxys' DPX™ technology ("DPX") is a patented delivery platform that can incorporate a range of bioactive molecules, such as mRNA/polynucleotides, peptides/proteins, virus-like particles, and small molecules, to produce targeted, long-lasting immune responses enabled by various formulated components.  The DPX platform facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease.

Data from proof-of-concept studies of DPX-mRNA formulations conducted in collaboration with leading RNA technology company Etherna and PCI Biotech demonstrate that DPX provides enhanced in vitro and in vivo stability of packaged mRNA, attracts a therapeutically unique subset of Antigen Presenting Cells (APCs) to the injection site for targeted uptake of mRNA by the immune system, and that immunization with DPX containing mRNA induces specific immune responses towards encoded antigens.   

mRNA vaccines have emerged as a major scientific breakthrough in the development of immuno-therapeutics and have become the foundation for many new vaccine programs as the Covid pandemic accelerated the development of mRNA vaccines. The genetic sequence in mRNA vaccines instructs host cells to produce proteins to elicit immunological responses and prepare the immune system to fight infections or cancer cells.

During the pandemic, mRNA vaccines were proven to be highly effective, with billions of doses administered worldwide. However, their rapid development has led to challenges, particularly concerning relatively strong adverse reactions, including severe ones. Adverse reactions associated with current mRNA vaccines are primarily attributed to the LNPs that carry the mRNA. LNPs possess immunostimulatory properties and can spill out of the injection site, leading to systemic inflammatory responses.  While these adverse reactions may be considered acceptable for a limited number of doses during a pandemic, a safer platform that allows multiple doses over a lifetime is desirable for the extension of mRNA vaccine applications to other applications.

For instance, mRNA that is packaged using LNP- based vaccine delivery systems enters cells through endocytosis and faces several limitations and challenges such as systemic delivery leading to rapid degradation by nucleases, macrophage phagocytosis removal, and renal filtration clearance.  Due to their relatively short half-life, LNPs can show instability under in vivo conditions. Endosomal escape and removal through macrophages of lipid nanoparticles is possible without proper cellular uptake. Their instability and degradation affect their storage, delivery, and overall efficiency, compared with prior studies demonstrating that DPX™ recruits and activates unique subsets of antigen presenting cells ("APCs") to drive immunogenicity of antigens, exhibiting superior immune activation compared to aqueous and emulsion-based antigen delivery systems. The studies with Etherna and PCI Biotech demonstrated a preliminary, non-optimized, mRNA formulated in DPX with shelf-life integrity maintained for over the 14 days of the study, with mRNA formulated in DPX demonstrated to be stable for up to 14 days in vivo.  It was also seen that DPX attracts a unique subset of antigen presenting cells (APCs) to site of injection for targeted uptake of mRNA, with immunization with DPX containing mRNA inducing a specific immune response towards encoded antigens.

BioVaxys President and Chief Operating Officer Kenneth Kovan says "The DPX platform is essentially a 'pipeline from a product' and will play a significant commercial role for the Company as an enabling technology for delivering nucleic acids and other antigens.  DPX is ideal for mRNA delivery, as it remains localized and does not spill out from the injection site and has superior stability than LNPs. With better manufacturing economics than LNPs, it is generating interest from potential partners in the mRNA vaccine field."

BioVaxys has several issued patents related to DPX-mRNA formulations.

 * mRNA Vaccine Market Size And Forecast, Verified Market Research

About BioVaxys Technology Corp.

BioVaxys Technology Corp. (www.biovaxys.com) is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© 'neoantigen' tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization for food allergy, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company's clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX™ platform, and is in Phase IIB clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, DPX+rPA for peanut allergy prophylaxis, and BVX-0918, a personalized immunotherapeutic vaccine using its proprietary HapTenix© 'neoantigen' tumor cell construct platform for refractive late-stage ovarian cancer. BioVaxys common shares are listed on the CSE under the stock symbol 'BIOV', trade on the Frankfurt Bourse (FRA: 5LB), and in the US (OTCQB: BVAXF). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn.

ON BEHALF OF THE BOARD

Signed "James Passin"

James Passin, Chief Executive Officer
Phone: +1 740 358 0555

Cautionary Statements Regarding Forward Looking Information

This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Investors are encouraged to read BioVaxys continuous disclosure documents and audited annual consolidated financial statements which are available on SEDAR at www.sedar.com.

Logo: https://mma.prnewswire.com/media/2415135/5119958/BioVaxys_Technology_Corp_Logo.jpg

SOURCE BioVaxys Technology Corp.

FAQ

What are the advantages of BioVaxys' DPX platform over LNPs for mRNA vaccine delivery?

The DPX platform offers enhanced mRNA stability, remains localized at injection sites, attracts specific antigen presenting cells, and has better manufacturing economics compared to LNPs. It also demonstrates reduced adverse reactions typically associated with LNP-based delivery systems.

How long can mRNA remain stable in BioVaxys' (BVAXF) DPX platform?

According to preliminary studies, mRNA formulated in DPX demonstrated stability for up to 14 days both in shelf-life integrity tests and in vivo conditions.

What is the projected market size for mRNA vaccines that BioVaxys (BVAXF) is targeting?

The mRNA vaccine market is projected to grow to USD 48 billion by 2030, according to Verified Market Research.

Which companies has BioVaxys (BVAXF) collaborated with for DPX-mRNA studies?

BioVaxys has conducted proof-of-concept studies of DPX-mRNA formulations in collaboration with Etherna and PCI Biotech.

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