PapiVax Biotech’s PVX4 Receives TFDA Approval for Phase II Clinical Trial in Taiwan, advancing US-Taiwan Dual-Track Development of Therapeutic DNA Vaccine for CIN2/3

【TAIPEI】 PapiVax Biotech announced today (24 Feb.) that its proprietary HPV16 therapeutic DNA vaccine candidate, PVX4, has received approval from the Taiwan Food and Drug Administration (TFDA) to initiate a Phase II clinical trial in Taiwan. Following previous clearance from the US FDA to proceed with its Phase II study, this TFDA approval marks another significant milestone in PapiVax’s global multi-center clinical strategy, which will accelerate clinical data accumulation and the planning of subsequent global Phase III trials.

PapiVax indicated that PVX4 targets patients with moderate-to-severe cervical intraepithelial neoplasia (CIN2/3) confirmed to have HPV16 infection. The current standard of care relies heavily on invasive surgical resections, which can pose risks of cervical incompetence, premature birth, and psychological stress due to recurrence for women who still wish to bear children. The R&D strategy behind PVX4 is to induce high-efficiency T-cell immune responses, aiming to eliminate infected and precancerous cells via non-invasive immunotherapy, thereby addressing a critical unmet medical need.

This Phase II trial is designed as a randomized, double-blind, placebo-controlled study adhering to international standards, and it will evaluate the safety, immune response, and clinical efficacy of PVX4 in HPV16-positive women with CIN2/3 lesions. The trial also incorporates the TriGrid™ electroporation delivery technology to enhance DNA vaccine delivery efficiency and immune induction. PapiVax expects to achieve First Patient In (FPI) by the end of the second quarter. By driving progress simultaneously in both the US and Taiwan, the company aims to optimize patient enrollment and evidence accumulation efficiency, laying a pivotal foundation for future global Phase III trials.

PapiVax stated that it will steadfastly advance clinical development grounded in principles of science and transparency. By leveraging international regulatory pathways and multi-center trial strategies, the company aims to enhance the overall development efficiency and global partnering feasibility of PVX4, moving closer to its goals of bridging the therapeutic gap in CIN2/3 and expanding its global market presence.

【About PapiVax Biotech】 PapiVax Biotech focuses on the research and development of nucleic acid therapeutics and immunotherapies. Committed to addressing major unmet medical needs through innovative technologies, the company drives the development of globally competitive novel drugs and advances global multi-center clinical pipelines.