PBI Receives FDA Approval to Initiate Phase II Clinical Trial of PVX4 Vaccine Targeting High-Risk HPV- Related Cervical Lesions
May 31, 2025 – Papivax Biotech (PBI) announced today that its proprietary HPV16 vaccine candidate, PVX4, has received Phase II clinical trial approval from the U.S. Food and Drug Administration (FDA). This multicenter, multinational study marks a significant milestone in the company’s effort to advance cervical cancer prevention and treatment.
The clinical trial is designed as a randomized, double-blind, placebo-controlled Phase II study, aiming to evaluate the safety, efficacy, and immunogenicity of PVX4 in adult women diagnosed with CIN2/3 (moderate to severe cervical intraepithelial neoplasia) and confirmed HPV16 infection. Eligible participants will be randomly assigned in a 2:1 ratio to receive either PVX4 or placebo. The randomization codes will be generated by a computerized system, and blinded study drug dispensing will be handled by the site pharmacist.
Participants in the treatment group will receive 1 mg of PVX4 via intramuscular injection using the TriGrid™ electroporation system at Week 0, Week 4, and Week 8. The placebo group will receive normal saline injections following the same procedure. The study will be conducted under triple blinding to maintain the integrity of the results—neither investigators, evaluators, nor participants will know the treatment allocation.
Papivax Biotech emphasized that PVX4 is developed based on a next-generation DNA vaccine platform, combining a high-expression plasmid vector with an advanced electroporation delivery method. The goal is to elicit a stronger immune response and demonstrate therapeutic potential in patients with high-risk HPV-associated lesions.
“We are excited to receive FDA clearance to proceed with our Phase II trial, a major step forward in the clinical development of PVX4,” said the CEO of Papivax Biotech. “Through this study, we hope to validate PVX4’s potential in addressing unmet needs among women affected by persistent HPV16 infection and high-grade cervical lesions.”
Results from this trial will pave the way for a future global Phase III study and support PVX4’s path toward regulatory approval.
