BioVaxys Reports Positive Clinical Study Results from Phase 1B/2 PESCO Trial of MVP-S with Pembrolizumab (Keytruda (TM)) and Low-Dose Cyclophosphamide for Patients with Recurrent Epithelial Ovarian Cancer (EOC)

Executive Summary

• BioVaxys reported encouraging preliminary efficacy of MVP‑S combined with pembrolizumab and low‑dose cyclophosphamide in recurrent epithelial ovarian cancer.
• Overall response rate (ORR) was 24% overall, rising to 40% in platinum‑sensitive patients; disease control rate (DCR) reached 82% overall and 90% in the platinum‑sensitive cohort.
• A patient in the platinum‑sensitive cohort remained in complete response for three years (≈195 weeks), representing the longest observed immune‑mediated remission to date.

Key Details

• Study Design: Investigator‑initiated, open‑label, non‑randomized Phase 1B/2 (PESCO) trial; 47 patients total (16 dose‑escalation, 31 phase‑2).
• Primary Endpoints: Safety, recommended Phase 2 dose, ORR and DCR per RECIST 1.1.
• Secondary Endpoints: Efficacy in platinum‑sensitive (Cohort A) vs. platinum‑resistant (Cohort B) disease, progression‑free survival (PFS), overall survival (OS).
• Efficacy Results – Overall: ORR 24%; DCR 82%; median duration of response 5.5 months.
• Platinum‑Sensitive Cohort (A): ORR 40%; DCR 90%; longest immune response 195 weeks; one patient in complete response for 3 years post‑first vaccination.
• Platinum‑Resistant Cohort (B, n=24): ORR 16%; DCR 54% – exceeds historical single‑agent chemotherapy ORR ≈11.8%.
• Immunogenicity: Survivin‑specific immune responses detected in 62% of tested patients; correlated with disease control in 93% of patients.
• Safety/Tolerability: MVP‑S was well tolerated; no new safety signals reported (details omitted for brevity).
• Mechanistic Insight: DPX™ platform delivers antigens via a non‑systemic lipid‑in‑oil formulation, promoting sustained lymph‑node uptake and robust cytotoxic T‑cell activation.
• Quote: “The combination demonstrated promising and sustained clinical activity with good tolerability… These findings reinforce survivin as a viable target for immunotherapy in ovarian cancer.” – Kenneth Kovan, President & COO.

Notable Quotes

“The combination of MVP‑S, pembrolizumab and low dose cyclophosphamide in endothelial ovarian cancer demonstrated promising and sustained clinical activity with good tolerability… These findings reinforce survivin as a viable target for immunotherapy in ovarian cancer, together with checkpoint inhibitors such as anti‑PD‑1.” – Kenneth Kovan, President & COO

Materiality Assessment

Material – Positive – The release provides material, forward‑looking clinical data that could materially affect investor perception of BioVaxys’ pipeline and valuation.