Cross-Border Preparatory Framework for Gene Therapy Scale-Up Readiness
| Reference number | |
| Coordinator | Sox Therapeutics AB |
| Funding from Vinnova | SEK 500 000 |
| Project duration | October 2026 - March 2027 |
| Status | Ongoing |
| Venture | Preparation projects for international application within health |
| Call | Deepened international collaborations for healthy and resilient societies |
Purpose and goal
The project aims to formalize a strategic partnership between Sox Therapeutics AB and 3PBIOVIAN to advance SOX01 toward clinical trial readiness and future large-scale manufacturing. Key objectives are to establish legal, data-sharing and IPR governance frameworks, conduct a targeted regulatory gap analysis, and jointly develop a manufacturing and regulatory scaling roadmap to prepare for subsequent development phases.
Expected effects and result
The project will establish collaboration between Sox Therapeutics and 3PBIOVIAN and deliver a clinical and regulatory strategy for SOX01, including sex/gender considerations; a manufacturing scale-up and technology-transfer framework; an IPR/FTO framework; and a GDPR-compliant data-sharing plan. A strategic roadmap covering resource needs, timelines and funding opportunities will guide decisions on future clinical development, manufacturing scale-up and international collaboration.
Planned approach and implementation
The six-month project (Oct 2026–Mar 2027) is structured into three work packages: (1) establishing cross-border governance and assessing clinical and regulatory requirements; (2) evaluating manufacturing tech transfer, quality control, IPR and GDPR-compliant data sharing; and (3) developing a joint scale-up roadmap, resource plan and funding strategy. Sox Therapeutics leads the project in collaboration with Finnish partner 3PBIOVIAN and regulatory advisor RegSmart.