BIOVAXYS ANNOUNCES ISSUANCE OF DPX RELATED PATENT FROM THE U.S. PATENT AND TRADEMARK OFFICE
BioVaxys Technology Corp. (CSE: BIOV, OTCQB: BVAXF) has been issued U.S. Patent No. 12,042,537 by the USPTO for inducing an antibody immune response using a low dose volume delivery of a B-cell epitope formulated with DPX™. This proprietary lipid-based delivery platform allows for a robust and long-duration immune response. The technology enables delivery of less than 100 µl, packaging 5-50 µL of an antigen.
Potential applications include epitope-based vaccines for chronic hepatitis-B, influenza, and RSV. A previous Phase 1 study of DPX-RSV showed promising results, with 93% of participants maintaining antigen-specific immune responses after nine months. This patent issuance strengthens BioVaxys' position for further development and potential partnerships in epitope-based vaccine development.
BioVaxys Technology Corp. (CSE: BIOV, OTCQB: BVAXF) ha ricevuto il Brevetto Statunitense N. 12,042,537 dall'USPTO per l'induzione di una risposta immunitaria anticorpale utilizzando un metodo di somministrazione a basso volume di un epitopo B-cellulare formulato con DPX™. Questa piattaforma di somministrazione a base lipidica proprietaria consente una risposta immunitaria robusta e di lunga durata. La tecnologia permette la somministrazione di meno di 100 µl, confezionando 5-50 µL di un antigene.
Le potenziali applicazioni includono vaccini basati su epitopi per l'epatite cronica-B, l'influenza e l'RSV. Uno studio precedente di Fase 1 su DPX-RSV ha mostrato risultati promettenti, con il 93% dei partecipanti che ha mantenuto risposte immunitarie specifiche per l'antigene dopo nove mesi. L'emissione di questo brevetto rafforza la posizione di BioVaxys per ulteriori sviluppi e potenziali partnership nello sviluppo di vaccini basati su epitopi.
BioVaxys Technology Corp. (CSE: BIOV, OTCQB: BVAXF) ha recibido la Patente de EE. UU. N.º 12,042,537 por parte de la USPTO para inducir una respuesta inmune de anticuerpos utilizando una administración de bajo volumen de un epítopo de células B formulado con DPX™. Esta plataforma de entrega lipídica propietaria permite una respuesta inmune robusta y de larga duración. La tecnología permite la administración de menos de 100 µl, empaquetando de 5-50 µL de un antígeno.
Las aplicaciones potenciales incluyen vacunas basadas en epítopos para hepatitis crónica-B, influenza y RSV. Un estudio previo de Fase 1 de DPX-RSV mostró resultados prometedores, con el 93% de los participantes manteniendo respuestas inmunitarias específicas del antígeno después de nueve meses. La emisión de esta patente refuerza la posición de BioVaxys para un mayor desarrollo y posibles asociaciones en el desarrollo de vacunas basadas en epítopos.
BioVaxys Technology Corp. (CSE: BIOV, OTCQB: BVAXF)는 미국 특허 제12,042,537호를 USPTO로부터 수여받았습니다. 이는 DPX™로 조제된 B 세포 에피토프의 저용량 전달을 사용하여 항체 면역 반응을 유도하는 기술입니다. 이 독점적인 지질 기반 전달 플랫폼은 강력하고 지속적인 면역 반응을 가능하게 합니다. 이 기술은 100µl 이하의 양을 전달할 수 있으며, 항원을 5-50µL로 포장할 수 있습니다.
가능한 응용 분야로는 만성 B형 간염, 독감 및 RSV를 위한 에피토프 기반 백신이 포함됩니다. DPX-RSV의 이전 1상 연구는 유망한 결과를 보였으며, 참가자의 93%가 9개월 후에도 항원 특이적인 면역 반응을 유지했습니다. 이 특허의 발부는 BioVaxys가 에피토프 기반 백신 개발을 위한 추가 개발과 잠재적인 파트너십을 강화하는 데 도움을 줍니다.
BioVaxys Technology Corp. (CSE: BIOV, OTCQB: BVAXF) a reçu le Brevet américain n° 12,042,537 de l'USPTO pour l'induction d'une réponse immunitaire par anticorps utilisant une administration à faible volume d'un épitope B-cellulaire formulé avec DPX™. Cette plateforme de livraison lipidique propriétaire permet une réponse immunitaire robuste et de longue durée. La technologie permet la livraison de moins de 100 µl, permettant d'emballer 5-50 µL d'un antigène.
Les applications potentielles incluent des vaccins basés sur des épitopes pour l'hépatite chronique B, la grippe et le RSV. Une précédente étude de phase 1 du DPX-RSV a montré des résultats prometteurs, 93 % des participants maintenant des réponses immunitaires spécifiques à l'antigène après neuf mois. L'émission de ce brevet renforce la position de BioVaxys pour le développement futur et les partenariats potentiels dans la mise au point de vaccins basés sur des épitopes.
Die BioVaxys Technology Corp. (CSE: BIOV, OTCQB: BVAXF) hat vom USPTO das US-Patent Nr. 12,042,537 erhalten, das die Induktion einer Antikörper-Immunantwort unter Verwendung einer niedrig dosierten Volumenverabreichung eines B-Zellen-Epitops formuliert mit DPX™ betrifft. Diese proprietäre lipidhaltige Verabreichungsplattform ermöglicht eine robuste und langanhaltende Immunantwort. Die Technologie erlaubt die Verabreichung von weniger als 100 µl, was das Verpacken von 5-50 µL eines Antigens umfasst.
Mögliche Anwendungen umfassen epitopbasierte Impfstoffe gegen chronische Hepatitis-B, Influenza und RSV. Eine frühere Phase-1-Studie zu DPX-RSV zeigte vielversprechende Ergebnisse, wobei 93 % der Teilnehmer spezifische immunologische Antworten auf das Antigen nach neun Monaten aufrechterhielten. Die Patenterteilung stärkt die Position von BioVaxys für weitere Entwicklungen und potenzielle Partnerschaften in der Entwicklung epitopbasierter Impfstoffe.
- Issuance of U.S. Patent No. 12,042,537 for low dose volume delivery of B-cell epitope with DPX™
- Patent already allowed in Japan and pending in the European Union
- Potential applications in vaccines for chronic hepatitis-B, influenza, and RSV
- Previous Phase 1 study showed 93% of participants maintained immune responses after 9 months
- 100% of older adults maintained immune responses one year after booster dose in RSV study
- None.
This Patent was recently allowed in
DPX™ is a proprietary lipid-based delivery platform with no aqueous component that can be formulated with a range of packaged antigens, proteins, peptides, mRNA, or small molecules. Its unique "no release" mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and long-duration immune response.
The smallest dose of a currently approved vaccine is 0.1ml for Sanofi-Pasteur's Fluzone™ Intradermal Quadrivalent vaccine. Low dose volume delivery of DPX™ formulated B-cell epitope is designed to be delivered in single low dose volume of less than 100 µl that can package 5µL to 50 µL of of an antigen comprising a B-cell epitope.
An epitope is the part of an antigen that the host's immune system recognizes, eliciting the immune response to an invading pathogen. It specifically binds to the corresponding antigen receptor on the immune cell (such as a B-cell). Whereas T-cells protect people from getting infected by destroying cancerous and infected cells, B-cells produce antibodies to fight infection.
Potential applications of this technology include epitope-based vaccines for diseases such as chronic hepatitis-B, influenza, and Respiratory Syncytial Virus (RSV)---where BioVaxys' clinical study data is encouraging for product development.
In a prior randomized, observer-blinded, first-in-humans Phase 1 study of a novel synthetic RSV antigen based on the ectodomain of the small hydrophobic glycoprotein (SHe) of RSV subgroup A formulated with DPX ("DPX-RSV"), the data showed that more than nine months after the last vaccination, 15 of 16 participants (
BioVaxys President and Chief Operating Officer Kenneth Kovan stated "Issuance of this Patent by the USPTO expands the value of our IP and DPX platform, and puts the Company on strong footing for further development and partnering with companies developing epitope-based vaccines for diseases such as chronic hepatitis-B, influenza, and RSV, where we have such promising human study results."
About BioVaxys Technology Corp.
BioVaxys Technology Corp. (www.biovaxys.com), a biopharmaceuticals company registered in
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Signed "James Passin"
James Passin, CEO
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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.
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