VANCOUVER, BC — January 29, 2026 — Leads & Copy — BioVaxys Technology Corp. announced positive findings from a Phase 2 clinical study evaluating maveropepimut-S (MVP-S) in combination with pembrolizumab and low-dose cyclophosphamide in patients with advanced or metastatic bladder cancer.
The results build on the Company’s recent Phase 1B/2 data in advanced ovarian cancer and further validate the potential of MVP-S to enhance checkpoint inhibitor activity across multiple solid tumor indications. BioVaxys is 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.
The Phase 2 study, led by Oliver Rix, MD, PhD, Founder, Director, and Principal Investigator at Quantum Santa Fe, and Clinical Research Professor of Medicine at the University of New Mexico Comprehensive Cancer Center, assessed the safety, tolerability, and clinical activity of the combination regimen in patients with metastatic bladder cancer, including those who had progressed on prior anti-PD1/PD-L1 therapies.
Of 17 evaluable subjects, five showed objective responses: 2 confirmed complete responses (CRs) and 3 partial responses (PRs). Three responders—including both confirmed CRs—had previously progressed on prior checkpoint inhibitor therapy, suggesting the combination may overcome resistance in refractory settings. Several patients achieved durable clinical benefit, with one remaining on treatment beyond 18 months. The regimen was well tolerated.
Immunological data showed increases in survivin-specific T cells in peripheral blood, consistent with the DPX mechanism of action that promotes a targeted, cytotoxic T-cell response. These outcomes align with emerging evidence that combining MVP-S with checkpoint inhibitors can expand antigen-specific T cell responses, reduce regulatory T-cell activity, and amplify anti-tumor activity. Survivin, a tumor-associated antigen overexpressed in bladder cancer, ovarian cancer, and other malignancies—but minimally expressed in normal tissues—serves as an ideal target for this approach.
MVP-S is a DPX-based immunotherapy comprising multiple survivin-derived peptides, a T-helper peptide, and an innate immune stimulant. The DPX platform employs a novel, non-aqueous, lipid-in-oil formulation that promotes efficient antigen uptake and enables in vivo immune programming that mimics natural immune processes, resulting in a robust T-cell activation and durable response without systemic release at the injection site.
Kenneth Kovan, President & Chief Operating Officer of BioVaxys, said the Phase 2 bladder cancer data reinforces the synergistic potential of combining MVP-S with anti-PD1 therapy, building on promising results from the recent Phase 1B/2 study of MVP-S plus pembrolizumab in ovarian cancer. Kovan added that the encouraging activity, including complete responses in checkpoint-refractory patients, highlights survivin as a compelling target and strengthens the rationale for advancing MVP-S toward Phase 3 development in ovarian cancer and exploring broader partnering opportunities across additional indications.
Merck’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab), the dominant anti-PD1 cancer therapies, are nearing a significant patent cliff by 2028, with Libtayo (cemiplimab), Roche/Genentech’s Tecentriq (atezolizumab) and Astra Zeneca’s Imfinzi (durvalumab), also facing patent expirations within the next six years and looking for new data to help maintain their market leadership. According to Kovan, this represents a tremendous opportunity for MVP-S together with the 200-plus drug candidates in the PD-1 and PD-L1 Inhibitor pipeline.
BioVaxys continues to advance its infectious disease and oncology pipelines, with MVP-S demonstrating consistent tolerability and antigen-specific immune activation across multiple cancer indications, including recent positive data in HR(+) / HER2(-) stage II-III Breast Cancer, non-muscle invasive bladder cancer, relapsed/refractory Diffuse Large B-Cell Lymphoma, and recurrent epithelial Ovarian Cancer.
BioVaxys Technology Corp. 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 (FRA: 5LB) and in the U.S. on the OTC Markets (OTCQB:BVAXF).
Source: BioVaxys Technology Corp.
