Vancouver, British Columbia--(Newsfile Corp. - December 17, 2025) - BioVaxys Technology Corp. (CSE: BIOV) (FSE: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company"), a clinical stage biotechnology company focused on developing advanced treatments in oncology, infectious disease, allergy, and other immune diseases based on its DPX™ antigen delivery and immune-educating technology platform, is very pleased to announce 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 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.

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

MVP-S is a formulation of multiple peptides of survivin packaged in the Company's DPX, a highly unique liposome-based delivery platform designed to create a non-systemic, long-lasting, targeted immune responses. Survivins are a well-recognized cancer antigen commonly overexpressed in many tumors such as breast cancer, as well as an innate immune activator and a universal CD4 T-cell helper peptide, which 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. Survivin upregulation is strongly associated with a subpopulation of breast cancer patients that are resistant to breast cancer drugs in a class of chemotherapeutics known as aromatase inhibitors, which includes letrozole.

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.

Under the direction of Sasha Stanton, MD, PhD, of the Earle A. Chiles Research Institute, Providence Cancer Center, Portland, OR, a phase I trial evaluated immunologic effects of BioVaxys' MVP-S plus letrozole. The three postmenopausal patients with HR+/HER2-breast cancer and Ki67 levels >10% received two doses of MVP-S and 7 weeks of neoadjuvant letrozole prior to surgery. The Ki-67 marker is a protein used in breast cancer to measure the proliferation or growth rate of cancer cells. Elevated Ki-67 scores typically indicate a more aggressive tumor.

All three patients in the study had at least a 50% decrease in Ki67 between biopsy and surgery, from median 24% (from a range of 12% to 43%) before treatment to median 6% (from a range of 5% to 8%) after treatment. One patient had an 8-fold increase of survivin-specific circulating Interferon-gamma (IFN-γ) T cells at surgery. IFN-γ is a critical messenger molecule produced by T cells that promotes an effective cell-mediated immune response against cancer by activating immune cells.

In women with hormone receptor positive Her2 negative (HR+HER2-) breast cancer, neoadjuvant hormone therapy provides an alternative to chemotherapy with conversion from mastectomy to breast conservation in approximately half of patients2-3. However, one barrier to wide adoption of neoadjuvant hormone therapy is the variability in patient response. There is a significant unmet need for novel treatments in this population, as chemotherapy on its own does not induce complete response in the majority of these patients. Kenneth Kovan, President and Chief Operating Officer at BioVaxys says that "We are very encouraged by the positive clinical data from this study, as the use of MVP-S together with neoadjuvant hormone therapy could lead to a treatment for women with hormone receptor positive HER2 negative Stage II-III breast cancer."

BioVaxys and Dr. Stanton 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.

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.

2. Smith, I. E., Dowsett, M., Ebbs, S. R., Dixon, J. M., Skene, A., Blohmer, J. U., Ashley, S. E., Francis, S., Boeddinghaus, I. & Walsh, G. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: The Immediate Preoperative Anastrozole, Tamoxifen, or Combined With Tamoxifen (IMPACT) multicenter double-blind randomized trial. J. Clin. Oncol. 23: 5108-5116, 2005.

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.

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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/278219