BioVaxys Announces Phase 1 Clinical Study Results Advancing DPX(TM)-Formulated Products in Patients with Non-Muscle Invasive Bladder Cancer

Vancouver, British Columbia--(Newsfile Corp. - January 8, 2026) - BioVaxys Technology Corp. (CSE: BIOV) (FSE: 5LB0) (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 pleased to announce highly promising results from a two-arm phase 1 clinical study of the safety and immunogenicity of both its maveropepimut-S (MVP-S) and DPX-SurMAGE cancer vaccines in patients with non-muscle invasive bladder cancer (NMIBC). Treatment with either MVP-S or DPX-SurMAGE was shown to be well tolerated, with both products inducing significant systemic antigen-specific T cell responses, which is a critical goal in cancer immunotherapy.

MVP-S is a novel DPX-based formulation that delivers antigenic peptides from the survivin family, a set of well-recognized cancer antigens commonly overexpressed in advanced cancers such as bladder tumors, and also delivers an innate immune activator and a universal CD4⁺ T cell helper peptide. In previous human studies, MVP-S has been shown to be well tolerated and has demonstrated activation of a targeted and sustained, survivin-specific anti-tumor immune response in multiple cancer indications, such as in BioVaxys' recent phase 1 study of MVP-S with neoadjuvant hormone therapy in HR(+) / HER2(-) stage II-III breast cancer.

DPX-SurMAGE is a dual-targeted immunotherapy combining antigenic peptides for both survivin as well as MAGE-A9, both of which are tumor-associated antigens expressed by NMIBC, to elicit immune responses to these two distinct cancer antigens simultaneously.

Led by Dr Yves Fradet, MD (Professor of Urology/Surgery, Université Laval and Researcher at the Centre de Recherche du CHU de Québec-Université Laval, Québec, Canada), the phase 1 study compared three 3 subcutaneous injections, prior to transurethral resection, of the two DPX-based products from BioVaxys, MVP-S and DPX™-SurMAGE, with or without intermittent low-dose cyclophosphamide, as treatment for patients with recurrent low-grade or high-grade recurrent NMIBC who have failed intravesical therapy.

The primary objectives were to assess tolerability in humans and to evaluate clinical induction of systemic antigen-specific T-cell responses. Study arms were testing either MVP-S alone (targeting survivin-only in Study Arm A), or DPX-SurMAGE (targeting both survivin plus MAGE-A9 in Study Arm B). In total, 12 patients were evaluated, 9 in Arm A and 3 in Arm B. Both MVP-S and DPX-SurMAGE were shown to be well tolerated, with strong antigen-specific T cell responses at Day 0, 28, 49 and 109 determined using INF- γ ELISPOT analyses, a highly sensitive technique to count individual immune cells (typically T cells) that are actively secreting Interferon-gamma (IFN-γ) in response to a specific antigen to reveal the strength of response to a tumor antigen. Of note, 55% of participants receiving MVP-S showed significant responses that peaked at Day 28, and 33% in the DPX-SurMAGE Study Arm showed a significant response that was stronger at Day 49. "Despite the small number of patients tested, we were very impressed by the strength and duration of the T cell responses to a combination of immunogenic peptides against two molecules with very distinct biological activity: Survivin with anti-apoptotic activity and MAGE-A9, a typical cancer antigen known to stimulate T cells," noted Dr Yves Fradet.

The BioVaxys 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^TM platform presents antigens to the immune system using a novel non-systemic 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.

Dr Fradet added: "The patients enrolled in this phase I trial had multiple previous recurrences of high grade NMIBC. After an average two years of follow-up, many of these patients were free of recurrence, suggesting that this simple and well-tolerated vaccination could represent an attractive new treatment for NMIBC patients who failed BCG. It may be a valuable alternative to the many intravesical and systemic treatments currently being developed that warrants further investigation in a phase II trial."

The global bladder cancer market is projected to grow from $3 billion in 2023 to $16 billion in 2033, at a compound annual growth rate (CAGR) of 18% (GlobalData 2025), with the NMIBC market expected to be driven by therapies for patients who are unresponsive to BCG.

Kenneth Kovan, President and Chief Operating Officer at BioVaxys says that "We are very encouraged by the findings as both MVP-S and DPX-SurMAGE exhibit significant clinical proof-of-product and are now candidates for further clinical study in NIMBC. A major objective that was accomplished is the demonstration in humans that with DPX-SurMAGE we can package and deliver multiple dissimilar antigens which further builds our foundation for developing new multivalent infectious disease and cancer vaccines based on the DPX platform."