BioVaxys Reports Positive Phase 2 Data for Maveropepimut (MVP-S) + Pembrolizumab and Low-Dose Cyclophosphamide in Metastatic Bladder Cancer

Executive Summary

• BioVaxys reported positive Phase 2 data for maveropepimut‑S (MVP‑S) combined with pembrolizumab and low‑dose cyclophosphamide in metastatic bladder cancer.
• Among 17 evaluable patients, two achieved confirmed complete responses and three had partial responses; all five responders included two who were refractory to prior PD‑1/PD‑L1 therapy.
• The regimen was well tolerated and generated survivin‑specific T‑cell increases, supporting advancement toward Phase 3 development and broader partnership opportunities.

Key Details

• Study Design: Open‑label Phase 2 trial evaluating MVP‑S + pembrolizumab + low‑dose cyclophosphamide in advanced/metastatic bladder cancer patients, including those previously progressed on anti‑PD‑1/PD‑L1 therapy.
• Patient Cohort: 17 evaluable subjects.
• Efficacy Outcomes:
• 2 confirmed complete responses (CR).
• 3 partial responses (PR).
• All five responders demonstrated durable clinical benefit; one patient remained on treatment > 18 months.
• Three responders (including both CRs) had prior checkpoint‑inhibitor progression, indicating potential to overcome resistance.
• Safety/Tolerability: Regimen described as “well tolerated” with no new safety signals reported.
• Immunological Findings: Increases in survivin‑specific T cells observed in peripheral blood, consistent with DPX platform mechanism of targeted cytotoxic T‑cell activation.
• Strategic Implications: Results reinforce synergistic potential of MVP‑S with anti‑PD‑1 therapy; company plans to advance MVP‑S toward Phase 3 in ovarian cancer and explore additional indications/partnering opportunities.
• Market Context: Highlights upcoming patent expirations for major PD‑1/PD‑L1 antibodies (Keytruda, Opdivo, Libtayo, Tecentriq, Imfinzi) by 2028–2032, creating a commercial opportunity for MVP‑S.
• Pipeline Update: BioVaxys also cited positive data in HR(+)/HER2(−) breast cancer, non‑muscle invasive bladder cancer, relapsed/refractory diffuse large B‑cell lymphoma, and recurrent epithelial ovarian cancer.

Notable Quotes

“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.” – Kenneth Kovan, President & COO, BioVaxys Technology Corp.