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 study, led by Oliver Rix, MD, PhD, at Quantum Santa Fe and the University of New Mexico Comprehensive Cancer Center, assessed safety, tolerability, and clinical activity in patients including those who had progressed on prior anti-PD1/PD-L1 therapies.
Of 17 evaluable subjects, five showed objective responses: two confirmed complete responses and three 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, while 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 targeted cytotoxic T-cell responses.
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 mimicking natural immune processes.
Kenneth Kovan, President & Chief Operating Officer of BioVaxys, stated that the data reinforces the synergistic potential of combining MVP-S with anti-PD1 therapy and highlights survivin as a compelling target. This strengthens the rationale for advancing MVP-S toward Phase 3 development in ovarian cancer and exploring broader partnering opportunities across additional indications. The timing is significant as 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 other major therapies like Roche/Genentech’s Tecentriq (atezolizumab) and AstraZeneca’s Imfinzi (durvalumab) also facing patent expirations within six years. Kovan noted that together with over 200 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. The company’s clinical stage pipeline includes MVP-S in phase IIB clinical development for advanced relapsed-refractory Diffuse Large B Cell Lymphoma and platinum resistant ovarian cancer. For more information, visit https://www.biovaxys.com. The original release can be viewed on https://www.newmediawire.com.
