BioVaxys Phase 2 Data Shows Maveropepimut Combination Effective in Metastatic Bladder Cancer

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. These 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. 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 and 3 partial responses. Notably, three responders - including both confirmed complete responses - 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, and 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 robust T-cell activation and durable response without systemic release at the injection site.

Kenneth Kovan, President & Chief Operating Officer of BioVaxys, commented that building on the promising results from the recent Phase 1B/2 study of MVP-S plus pembrolizumab in ovarian cancer, this Phase 2 bladder cancer data reinforces the synergistic potential of combining MVP-S with anti-PD1 therapy. 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. Kovan adds that together with the 200-plus drug candidates in the PD-1 and PD-L1 Inhibitor pipeline, this represents a tremendous opportunity for MVP-S.

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. 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. For more information about the company, visit https://www.biovaxys.com.