PRV-101 program advances: Phase 1b preparations progressing well and the manufacturing of clinical trial supplies initiated
Tampere, Finland – Vactech Oy is advancing its PRV-101 development program toward the next clinical milestone. Following the successful completion of the Phase 1a clinical study, the company has initiated preparations for the upcoming Phase 1b trial. These activities have progressed well, supported by strengthened internal resources and the start of manufacturing materials for the Phase 1b clinical trial, including vaccine and placebo.
Strong scientific foundation: Phase 1a results published in Diabetologia
The Phase 1a clinical trial results for PRV-101 have been published in Diabetologia, demonstrating a favourable safety and tolerability profile and robust, dose-dependent neutralizing antibody responses against all Coxsackie B virus serotypes included in the vaccine. Protective-level responses were maintained throughout the 24-week follow-up in more than 90% of participants, and subsequent follow-up indicated antibody persistence beyond two years.
Phase 1b preparations underway: progressing towards paediatric evaluation
Vactech is now preparing for the Phase 1b clinical study, designed to further evaluate PRV-101 in the next stage of clinical development. Preparations include finalizing the clinical protocol, ensuring operational readiness for trial initiation, and confirming quality and compliance across key processes.
“Building on the successful Phase 1a outcomes and publication, we are advancing Phase 1b preparations as planned and strengthening our capabilities to execute the next clinical phase to the highest standards,” says Tero Välimaa, Chief Executive Officer of Vactech.
Strengthened capabilities to support clinical advancement
As the PRV-101 program progresses, Vactech has reinforced its human resources, particularly across clinical development, quality, and operational execution. These enhancements are intended to support Phase 1b planning, clinical trial coordination, and effective collaboration with partners.
“Vactech’s decision to take the next step in the PRV-101 program is based on strong scientific evidence on the role of Coxsackie B viruses in T1D and the ability of PRV-101 to induce protective antibodies against these viruses. This is a crucial part of our mission to develop prevention for T1D”, notes Heikki Hyöty, Founder and Chairman of the Board of Vactech.
Manufacturing of clinical trial materials initiated
To support the Phase 1b study, Vactech is initiating the manufacturing of clinical trial materials, including both the PRV-101 vaccine and placebo. This step marks an important milestone in ensuring readiness for trial start, with production and documentation aligned with applicable clinical quality and regulatory requirements.
“From a clinical perspective, it is crucial to move forward stepwise and with rigorous execution—especially as we prepare for studies in paediatric populations,” says Mikael Knip, Member of the Board and Co-founder of Vactech.
About Vactech
Vactech is a biotechnology company, specializing in the research and development of innovative vaccines and medical solutions. The company is pioneering the future of immunology through vaccine and diagnostic technologies targeting type 1 diabetes (T1D), celiac disease, and enterovirus-related conditions. Vactech’s mission is to advance research with real-world impact by combining academic excellence with strong commercial potential and strategic industrial partnerships.