BIOVAXYS ANNOUNCES ISSUANCE OF DPX RELATED PATENT FROM THE U.S. PATENT AND TRADEMARK OFFICE

Biotech
Tuesday, July 23rd, 2024 1:59 pm EDT

VANCOUVER, BC, July 23, 2024 /PRNewswire/ — BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (“BioVaxys” or “Company”) announced that the United States Patent and Trademark Office (“USPTO”) has issued BioVaxys U.S. Patent No. 12,042,537. (“Patent”) for inducing an antibody immune response from a low dose volume delivery of a B-cell epitope formulated with DPX™.

This Patent was recently allowed in Japan and is currently pending in the European Union.

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 (93%) who received DPX-RSV demonstrated antigen-specific immune responses.  One dose was tested out to one year and 100% of older adults (7/7 immune responders) maintained antigen-specific immune responses one year after receiving the booster dose. After one year, their antibody levels measured were still at peak with no sign of decrease.

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 British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it’s HapTenix© ‘neoantigen’ tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company’s clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using its’ proprietary HapTenix© ‘neoantigen’ tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit www.biovaxys.comand connect with us on X and LinkedIn.

ON BEHALF OF THE BOARD
Signed “James Passin”

James Passin, CEO
+1 646 452 7054

Cautionary Statements Regarding Forward Looking Information

The CSE has neither approved nor disapproved the contents of this press release. The CSE does not accept responsibility for the adequacy or accuracy of this release. 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.

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SOURCE BioVaxys Technology Corp.