BioVaxys Announces Phase 1 Clinical Study Results Advancing DPX(TM)-Formulated Products in Patients with Non-Muscle Invasive Bladder Cancer

Executive Summary

• BioVaxys announced promising Phase 1 safety and immunogenicity data for its MVP‑S and DPX‑SurMAGE cancer vaccines in non‑muscle invasive bladder cancer (NMIBC) patients.
• Both vaccine candidates were well tolerated; 55% of MVP‑S recipients and 33% of DPX‑SurMAGE recipients showed significant, durable antigen‑specific T‑cell responses.
• The results support progression to a Phase II trial and demonstrate the platform’s ability to deliver multiple dissimilar antigens in a single formulation.

Key Details

• Study Design: Two‑arm, open‑label Phase 1 trial; three subcutaneous injections given prior to transurethral resection, with/without low‑dose cyclophosphamide.
• Patient Cohort: 12 NMIBC patients (9 in Arm A – MVP‑S alone; 3 in Arm B – DPX‑SurMAGE).
• Safety: No significant safety concerns reported for either vaccine; both were “well tolerated.”
• Immunogenicity – MVP‑S (Arm A):
• 55% of participants showed significant T‑cell responses, peaking at Day 28.
• Immunogenicity – DPX‑SurMAGE (Arm B):
• 33% of participants exhibited strong T‑cell responses, strongest at Day 49.
• Assay Method: IFN‑γ ELISPOT analyses performed on Days 0, 28, 49, 109.
• Clinical Observation: After ~2 years follow‑up, many patients remained free of recurrence, suggesting potential efficacy in BCG‑refractory NMIBC.
• Scientific Rationale:
• MVP‑S delivers survivin peptide antigens plus an innate immune activator and CD4⁺ helper peptide.
• DPX‑SurMAGE combines survivin and MAGE‑A9 peptides, targeting two distinct tumor antigens simultaneously.
• Platform Commentary: The DPX™ “no‑release” delivery system forces active uptake of antigen by immune cells, directing them to lymph nodes for sustained activation.
• Future Plans: Company intends to initiate a Phase II trial to further evaluate efficacy and safety in NMIBC.

Notable Quotes

“Despite the small number of patients tested, we were very impressed by the strength and duration of the T‑cell responses…,” – Dr. Yves Fradet, MD.

“We are very encouraged by the findings as both MVP‑S and DPX‑SurMAGE exhibit significant clinical proof‑of‑product and are now candidates for further clinical study in NMIBC,” – Kenneth Kovan, President & COO.

Materiality Assessment: Material – Positive (the release provides substantive, forward‑looking clinical data that could materially affect the company’s development pipeline and valuation).