- FamiCord AG said its CDMO brand Bramble Bio has entered into a manufacturing agreement with Swedish biotechnology company VERIGRAFT AB covering technology transfer and manufacturing preparation for P-TEV.
- The approximately 18-month collaboration will support the planned TECVI-2 Phase II/III trial, with manufacturing activities taking place at Bramble Bio’s GMP site in Warsaw, Poland.
FamiCord AG said its CDMO brand Bramble Bio has entered into a manufacturing agreement with Swedish clinical-stage biotechnology company VERIGRAFT AB for its lead product candidate P-TEV. The agreement covers the transfer and establishment of the manufacturing process, as well as support for sourcing and qualifying donated human vein tissue used as starting material for P-TEV manufacturing.
Technology transfer activities to Bramble Bio’s GMP site in Warsaw, Poland, will begin immediately. The company will conduct process transfer, manufacturing preparation and related GMP activities needed to supply the planned multi-country clinical trial. The collaboration is expected to run for approximately 18 months and has an estimated contract value in the low single-digit millions of euros, depending on clinical program progress, patient recruitment and associated manufacturing requirements.
The work will support TECVI-2, a randomized, controlled, open-label Phase II/III pivotal trial designed to evaluate P-TEV in a larger patient population. Clinical sites are planned in Spain, Poland and the Netherlands. The trial is currently authorized in Spain, while approval in Poland and the Netherlands is expected in the fourth quarter of 2026. TECVI-2 is expected to begin in the first quarter of 2027 and will evaluate P-TEV as a potentially curative treatment for patients with severe chronic venous insufficiency (CVI).
P-TEV is a personalized, fully biological tissue-engineered vein with a functioning valve. The manufacturing process begins with donated venous tissue, which is decellularized to remove donor cells while preserving the native tissue and valve structure. The resulting matrix is then reconditioned with the patient’s own blood to create a personalized graft designed to replace a diseased vein segment containing a non-functioning valve and restore venous function without immunosuppressive treatment.
FamiCord said the agreement further expands its CDMO activities. Bramble Bio provides technology transfer, process development and optimization, GMP manufacturing, cellular starting-material sourcing, analytical services and international logistics. In addition to its Warsaw facility, the CDMO operates a GMP site in Cantanhede, Portugal.
