BioVaxys Licensee SpayVac-for-Wildlife, Inc., Reports Further Positive Single-Dose Efficacy Data for Its Immunocontraceptive Vaccine and Initiation of Regulatory Submission Process

BioVaxys Licensee SpayVac-for-Wildlife, Inc., Reports Further Positive Single-Dose Efficacy Data for Its Immunocontraceptive Vaccine and Initiation of Regulatory Submission Process

BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys") and SpayVac for Wildlife, Inc. are pleased to announce 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.[1] A single-dose of its immunocontraceptive vaccine SpayVac™ vaccine ("SpayVac") significantly reduced fertility to 11% in vaccinated deer compared to a fertility rate of 86% in control animals. 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. (CSE: BIOV) (FRA: 5LB). The liposomes are composed of naturally occurring phospholipids. These liposomes encapsulate the antigen and improve the immune system's response to vaccination.

 

BioVaxys Technology Corp. (PRNewsfoto/BioVaxys Technology Corp.)

 

The one-year study was done with 47 free-ranging red deer (Cervus elaphus) and used camera traps, GPS collars, and fecal progesterone metabolites to intensively monitor pregnancies. The contraceptive efficacy of SpayVac has now been clinically validated in three distinct deer species: fallow deer (Dama dama), white-tailed deer (Odocoileus virginianus), and red deer. These results indicate a broad potential for SpayVac to be successfully applied across a wide range of deer populations. 

SpayVac-for-Wildlife has initiated the submission process to secure regulatory approval for SpayVac, its first product targeting feral horses and free-ranging deer populations. Kenneth Kovan, President & Chief Operating Officer of BioVaxys, says: "SpayVac is further clinical demonstration of the single-dose, long-duration efficacy provided by our vaccine technology platform, and with tens of millions of deer worldwide, the commercial potential for SpayVac is significant. We anticipate a healthy royalty stream from SpayVac vaccine sales."

Deer populations can double in size every 2 years, especially where natural predators have been extirpated.[2] In the U.S., overabundant deer can cause extensive damage to agricultural crops and, in suburban areas, they are one of the primary hosts for ticks that carry and spread Lyme disease, contribute to animal–vehicle collisions, damage vegetation, can adversely affect other wildlife, and facilitate disease transmission of other tick-borne diseases. Managing deer populations through non-lethal means is of significant interest, especially where hunting is not possible or favored. Surgical sterilization is available, though it involves higher costs, greater invasiveness, and requires more time. Long-lasting, single-dose, immunocontraception provides an alternative that is less invasive and may be more cost-effective. A single injection of SpayVac reduced fertility to 0-20% for 3 to 5 years in fallow and white-tailed deer studies.[3] "It's just not feasible to vaccinate free-ranging deer, give them a booster, and then administer boosters on an annual basis. SpayVac is a game changer in that respect. It can have a meaningful impact in efforts to manage overabundant deer populations," says Dr. Mark Fraker, VP of Operations at SpayVac-for-Wildlife, Inc.

SpayVac trials with feral horses, farmed trout, Asian elephants, and other species are ongoing. Tom D'Orazio, SpayVac's CEO, says: "These results are another example of replication and proof of concept that SpayVac pZP vaccine is very effective. It replicates other results we've seen in deer and other species. Therefore, we continue developing indications and other vaccines for markets where SpayVac might offer an appealing alternative to spaying or short-acting immunocontraceptives in farm-production animals and companion animals."

References

  1. Velling, M., Peters, A., Ferry, N., Bechert, U., Göritz, F., Schwarzenberger, F., Mysterud, A., Müller, J., and Heurich, M. 2025. One-time administration of SpayVac® vaccine successfully prevents pregnancy in red deer (Cervus elaphus) in a temperate forest ecosystem. European Journal of Wildlife Research 71(113):1-12.
  2. Paddock, C., Yabsley, M. 2007. Ecological havoc, the rise of white-tailed deer, and the emergence of Amblyomma americanum - associated zoonoses in the United States. Curr. Top. Microbiol. Immunol. 315:289–324.
  3. Boulanger, J., Curtis, P., Cooch, E., DeNicola, A. 2012. Sterilization as an alternative deer control technique: a review. Human-Wildl. Interact. 6:273–282.

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 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" and trade on the Frankfurt Bourse (FRA: 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.

About SpayVac-for-Wildlife

SpayVac for Wildlife, Inc., (https://spayvac.com) based in Madison, Wisconsin, develops humane fertility-control vaccines for animals. SpayVac contraceptive vaccines are effective in a variety of species for multiple years with just a single injection. SpayVac is a combination of an active ingredient encapsulated in a proprietary lipid nanoparticle. For questions about this research or SpayVac in general, please email contact@spayvac.com or follow us on LinkedIn at https://www.linkedin.com/company/spayvac.

ON BEHALF OF THE BIOVAXYS BOARD
Signed "James Passin"
James Passin, Chief Executive Officer
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. Forward-looking statements in this news release relate to, among other things, the Offering, including the expected use of proceeds from the Offering. 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 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.

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. Such factors include, without limitation, the risk that the Company does not use the proceeds from the Offering as currently expected. 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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SOURCE BioVaxys Technology Corp.

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