BioVaxys Announces Positive Phase 1 Clinical Study Results with Maveropepimut-S (MVP-S) in Women with Hormone Receptor Positive/HER2 Negative (HR+/HER2-) Stage II-III Breast Cancer

Executive Summary

• BioVaxys announced positive immunologic and biomarker results from a phase I trial of its MVP‑S vaccine combined with neoadjuvant letrozole in HR⁺/HER2‑ stage II‑III breast cancer patients.
• All three enrolled patients showed ≥50 % reduction in Ki‑67 proliferation marker, with median Ki‑67 dropping from 24 % pre‑treatment to 6 % post‑treatment.
• One patient exhibited an eight‑fold increase in survivin‑specific IFN‑γ–producing T cells at surgery, indicating a robust vaccine‑induced immune response.

Key Details

• Study Design: Open‑label phase I trial; three post‑menopausal HR⁺/HER2‑ breast cancer patients with baseline Ki‑67 > 10 % received two doses of MVP‑S plus 7 weeks of letrozole prior to surgery.
• Ki‑67 Results:
• Patient range pre‑treatment: 12 %–43 %; median 24 %.
• Post‑treatment range: 5 %–8 %; median 6 %.
• All patients achieved ≥50 % reduction.
• Immune Response: One patient demonstrated an eight‑fold rise in survivin‑specific circulating IFN‑γ⁺ T cells at the time of surgery.
• Clinical Implication: The combination may enhance tumor immune environment and improve response to neoadjuvant hormone therapy, potentially expanding breast‑conserving options.
• Future Plans: BioVaxys intends to expand immunologic profiling of pre‑ and post‑treatment biopsies and pursue a phase II trial of MVP‑S in high‑risk HR⁺ breast cancer.
• Market Context: Global HER2‑negative breast cancer market valued at $14.4 B (2024) with projected growth to $21.5 B by 2030; HR⁺/HER2‑ tumors represent ~57.8 % of this segment.
• Executive Quote: “We are very encouraged by the positive clinical data… could lead to a treatment for women with hormone receptor‑positive HER2‑negative stage II‑III breast cancer,” – Kenneth Kovan, President & COO.

Notable Quotes

“We are very encouraged by the positive clinical data from this study, as the use of MVP‑S together with neoadjuvant hormone therapy could lead to a treatment for women with hormone receptor positive HER2 negative Stage II‑III breast cancer.” – Kenneth Kovan, President & COO, BioVaxys.