VANCOUVER, BC, December 31st. 2025 / - TheNewswire - BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF) (FRA: 5LB) ("BioVaxys" or the "Company") is pleased to provide a summary of operating initiatives over the past year following the integration of the DPX™ platform into the BioVaxys business.  

The Company's focus continues to drive organic growth by:

• Expanding its early-stage pipeline by pursuing multiple out licensing opportunities and research collaborations where the Company's DPX platform can address specific needs  

• Reducing internal risk & the considerable funding requirements of late-stage clinical studies by out-licensing maveropepimut-S (MVP-S) in selected indications seeking a co-development partner for DPX-formulations in infectious diseases. 

• Re-engagement of clinical trial investigators for continuations of phase 1 studies of DPX formulations  

The Company's DPX platform is a major innovation in vaccine development that offers a solution to limitations faced by vaccines using other antigen delivery methods. The DPX platform delivers active ingredients to the immune system using a novel mechanism of action that does not release active ingredients at the site of the injection, but rather forces an active uptake of immune cells and delivery into the lymphatic nodes. The programming of immune cells happens in vivo and offers a more efficient approach that mimics the natural function of the immune system. This "no release" mechanism allows for an active uptake of antigens into immune cells and lymph nodes for a sustained activation of the immune system in which the T cell flow is sustained over a longer duration than traditional vaccines on the market.

Enhanced Scientific and Business Development Expertise

In 2025, BioVaxys made significant enhancements to its scientific and business development expertise through the addition of Dr. James Tartaglia to the Company’s Board of Directors, and Dr Marianne Stanford as Scientific Advisor.  

Dr. Tartaglia is an internationally recognized vaccine R&D leader with over 34 years of industry experience, including contributions to partnerships with private sector, government and international agencies.  Dr. Tartaglia recently retired as Global Head of Vaccine Development and Life Cycle Management for Sanofi.  During his twenty-seven years at Sanofi, Dr. Tartaglia was responsible for a vaccine portfolio of 25 projects extending from phase I/II through life cycle management in the areas of influenza, pediatric combination vaccines, RSV, rabies, Yellow Fever, pneumococcal and meningococcal vaccines. Over his career, Dr. Tartaglia has been involved in the licensure of 20 vaccines in veterinary and human health. Prior to Sanofi, he was Executive Director of Research at Virogenetics Corporation, a former subsidiary of Sanofi Pasteur. At Virogenetics he helped develop the poxvirus vector technology as an immunization vehicle for both veterinary and human application, including HIV and cancer.  He is an inventor on over 20 patents relating to recombinant vaccines and has authored over 130 publications in the areas of molecular virology and recombinant vaccine technology and participates as associate editor and/or reviewer for several peer-reviewed journals.

Dr Stanford was Vice President of R&D at the former IMV Inc, where she and her team were responsible for the development of the DPX™ vaccine portfolio. This included the study of the unique mechanism of action of the DPX platform and its safety, efficacy, and dosing schedules in preclinical models. Under her leadership, Dr. Stanford’s team also demonstrated that combining DPX, cyclophosphamide and then PD-1 blockade (using antibodies such as pembrolizumab, Merck’s Keytruda™) enhanced immunogenicity and thus efficacy in cancer models.  Dr. Stanford and collaborators have published numerous studies and she is named inventor on multiple patents related to the DPX platform and DPX formulations. This includes patents that explore DPX compositions that express mRNA encoded by the nucleic acid components in targeted cells.

With new doors opening from its Scientific Advisors and Board, BioVaxys has been engaging in outreach efforts with major vaccine and pharma companies to introduce the DPX platform and explore research collaborations in the infectious disease field for its RSV and flu vaccine programs, as well as for new DPX-based formulations in cancer and viral diseases.

Clinical Studies

Phase 1 Study of MVP-S in HR+ / HER2- Stage II-III breast cancer

Earlier this month, BioVaxys announced positive results from a phase 1 clinical study of maveropepimut-S ("MVP-S") along with neoadjuvant hormone therapy in women with hormone receptor positive HER2 negative (HR+HER2-) stage II-III breast cancer.  

The global market for HER2-negative breast cancer was valued at $14.4 billion in 2024 and is projected to reach $21.5 billion by 2030. HR+/HER2- tumors represent the largest subgroup within this market, accounting for an estimated 57.77% of the total revenue share in 2024.1

The clinical study demonstrated that BioVaxys' MVP-S in combination with letrozole (a commonly used neoadjuvant hormone therapy for treating some types of breast cancer by decreasing the amount of estrogen hormone your body makes) generated a strong immune response in study participants with positive HER2 negative (HR+HER2-) stage II-III breast cancer.  Patients in the study had at least a 50% decrease in Ki67 levels from median 24% before treatment to median 6% after treatment. Ki-67 is a protein marker used in breast cancer to measure the proliferation or growth rate of cancer cells, with elevated levels typically indicating a more aggressive tumor. One patient had an 8-fold increase of survivin-specific circulating Interferon-gamma (IFN-γ) T cells, which is a critical messenger molecule produced by T cells that promotes an effective cell-mediated immune response against cancer by activating immune cells.

BioVaxys and the investigating team at Providence Cancer Center in Oregon now plan to further evaluate the systemic immunity of MVP-S and conduct expanded profiling of biopsy compared to post-treatment surgical samples, using the additional data to pursue a phase II study with MVP-S to modify the tumor immune environment in high-risk HR+ breast cancer.

Collaborations and Licensing

BioVaxys/Sona Nanotech

In May 2025, the Company and Sona Nanotech Inc. ("Sona") jointly announced that they entered into a research agreement to collaborate on the development of new cancer therapeutics based on the Company's DPX Immune Educating Platform in combination with Sona's Targeted Hyperthermia Therapy™ (“THT”), a photothermal cancer therapy that uses highly targeted infrared light and intra-tumoral gold nanorods to treat solid tumors. The collaboration will evaluate the immune stimulatory properties of DPX (without an antigen cargo) administered together with THT, as a characteristic of DPX is that it helps prime the innate immune system which in turn can activate and strengthen the adaptive immune response. The collaboration will also evaluate the combination use of THT together with a DPX formulation as a carrier for novel neoantigens expressed on the surface of tumor cells following immunotherapy, such as with THT. Neoantigens are unique proteins that are not present in healthy tissues that arise from changes in cancer cells and play a crucial role in stimulating anti-tumor immune response. Immunotherapy such as THT can trigger these tumor cell changes and the expression of neoantigens, so packaging a tumor neoantigen in DPX for presentation to the immune system is anticipated to accelerate THT's efficacy. The research studies based on the BioVaxys and Sona technologies will be conducted at Dalhousie University, Halifax, Nova Scotia, under the direction of Sona's CMO, Carman Giacomantonio, MD MSc FRCSC, Division of General and Gastrointestinal Surgery, Department of Pathology, Dalhousie University, and Barry Kennedy, PhD, of the Giacomantonio Immuno-Oncology Research Group at Dalhousie University.

Maveropepimut-S (MVP-S)

To reduce internal risk and the considerable funding requirements of late-stage clinical studies, BioVaxys has been exploring out-licensing maveropepimut-S (MVP-S) in selected indications.  In addition to previous licensing discussions this year, the Company has been in discussions with a global pharma company interested in licensing maveropepimut-S (MVP-S) for ovarian cancer.  Although in early stages of a transaction, this potential licensee sees MVP-S as an excellent fit for expanding its footprint in oncology.  BioVaxys President and Chief Operating Officer Kenneth Kovan stated "The clinical data from MVP-S is very compelling and we think the vaccine can become a valuable tool in cancer immunotherapy. The significant investment for internal development of a later-stage program is such that it makes more sense for remaining clinical studies with MVP-S to be pursued by a company with the appropriate resources, as this potential partner certainly does.”

DPX+mRNA Formulations

The Company and a prospective partner in the animal health field have agreed to advance a research collaboration for a proof-of-product program to evaluate a DPX formulation of a proprietary mRNA sequence for diseases requiring long-duration protection such as rabies.  The research agreement governing the collaboration is expected to be finalized and announced early 2026.

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

Kovan says "The DPX platform is ideal for mRNA delivery, as it remains localized and does not spill out from the injection site and has superior stability than LNPs.  We are looking forward to this collaboration as it will advance our current proof-of-concept data for DPX+mRNA formulations and provide us with proof-of-product, give us another pipeline asset, and lay the foundation to explore other mRNA formulations.”

DPX-RSV

The Company is seeking a partner for further clinical development of its DPX-RSV for Respiratory Syncytial Virus (“RSV”), which successfully completed a phase 1 human study for safety and efficacy. DPX-RSV demonstrated antigen-specific immune responses in 93% of subjects, with 100% of responders in a 25μg single-dose cohort maintaining antigen-specific immunity one year post vaccination. Currently available RSV vaccines including GSK's Arexvy, Moderna's mResvia, and Pfizer's Abrysvo target either the F or G proteins of the virus and provide protection by neutralizing the RSV virus. Clinical measures of efficacy focus on the amount of neutralizing antibodies in the bloodstream. DPX-RSV works differently, as it targets the SH viral ectodomain of the RSV virus and, instead of neutralizing the virus, it enables the immune system to recognize and destroy RSV-infected cells.  

Additional infectious disease programs in the BioVaxys portfolio that are potential out-license candidates include DPX-rHA/DPX-FLU, an influenza vaccine candidate of recombinant hemagglutinin (whole protein ~300 amino acids) / whole heat killed virus package in DPX, and DPX-rPA, an and an anthrax vaccine consisting of DPX+ recombinant anthrax protective antigen. Animal challenge studies performed with lethal anthrax respiratory exposure levels with our DPX-based anthrax vaccine demonstrated 100% immunity following a single injection compared to current vaccines which require more than one dose.

Kovan stated "With input from Dr. Tartaglia, we have been aggressively conducting targeted outreach to major vaccine companies and international vaccine initiatives to introduce the DPX platform and share its capabilities, with several discussions already ongoing.”

Licensees: SpayVac for Wildlife, Inc. and Zoetis, Inc.

The Company has revenue generating licenses with Zoetis Inc. and SpayVac-for-Wildlife, Inc. for vaccines in the animal health field based on the Company's lipid encapsulation technology, with both licensors making excellent progress towards commercialization.

SpayVac for Wildlife, Inc., initiated the submission process to secure regulatory approval for SpayVac™, a pZP immunocontraceptive vaccine targeting feral horses and free-ranging deer populations. At the core of SpayVac is a patented technology for a liposome-based delivery platform designed to create long-lasting, targeted immune responses that is licensed from BioVaxys Technology Corp.  

SpayVac for Wildlife, Inc also announced this fall that results from a collaborative research project conducted in the Bavarian Forest National Park in Germany have recently been published in the European Journal of Wildlife Research.  A single-dose of SpayVac significantly reduced fertility to 11% in vaccinated deer compared to a fertility rate of 86% in control animals.

Ongoing research with other antigens is targeting commercial aquaculture, companion animals, and other applications. In April 2025, the Company announced the expansion of the Fields of Use in the current License Agreement with SpayVac to include commercial aquaculture, plus the farm-raised fish market, which will further increase BioVaxys' royalty revenue.

Zoetis is preparing for regulatory submission for a pZP immunocontraception vaccine based on the Company's lipid encapsulation technology for cattle in Australia and Brazil.

James Passin, CEO, stated, “In 2025, we have continued to build a world-class team of advisors and directors to help the Company develop and monetize its extraordinarily undervalued DPX IP portfolio. We look forward to advancing and crystallizing ongoing out-licensing and research collaboration discussions in 2026, a year in which we anticipate aggressive business development activity and booking our first royalty income.”  

1. Ellis, M. J., Suman, V. J., Hoog, J., Lin, L., Snider, J., Prat, A., Parker, J. S., Luo, J., DeSchryver, K., Allred, D. C., Esserman, L. J., Unzeitig, G. W., Margenthaler, J., Babiera, G. V., Marcom, P. K., Guenther, J. M., Watson, M. A., Leitch, M., Hunt, K., et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: Clinical and biomarker outcomes and predictive value of the baseline PAM50-based int. J. Clin. Oncol. 29: 2342-2349, 2011. 

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© 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, 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 the survivin family, a set of well-recognized cancer antigens 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" and trade on the Frankfurt Bourse (FSE: 5LB) and in the U.S. on the OTC Markets (OTCQB: BVAXF). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn.

ON BEHALF OF THE BIOVAXYS BOARD

Signed "James Passin" / James Passin, Chief Executive Officer

Office Phone: +1 740 358 0555

Cautionary Statements on Forward-Looking Information

This news release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein, without limitation, statements relating to 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.

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 BioVaxys, 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 DPX platform 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.

Many factors, both known and unknown, could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements and the parties have made assumptions and estimates based on or related to many of these factors. BioVaxys 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 applicable securities laws.

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