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, which build on previous Phase 1B/2 data in advanced ovarian cancer, validate the potential of MVP-S to enhance checkpoint inhibitor activity across multiple solid tumor indications.
The study, led by Dr. Oliver Rix at Quantum Santa Fe and the University of New Mexico Comprehensive Cancer Center, assessed the safety, tolerability, and clinical activity of the combination regimen 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. 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.
Kenneth Kovan, President & Chief Operating Officer of BioVaxys, commented that the 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.
The timing of these developments is significant as major anti-PD1 cancer therapies approach patent expirations. Merck's Keytruda (pembrolizumab) and Bristol Myers Squibb's Opdivo (nivolumab) are nearing a significant patent cliff by 2028, with other therapies like Libtayo (cemiplimab), Roche/Genentech's Tecentriq (atezolizumab), and Astra Zeneca's Imfinzi (durvalumab) also facing patent expirations within the next six years. Kovan noted 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. For more information about the company's clinical programs, visit https://www.biovaxys.com.
