EQS-News: FamiCord AG wins promising new client for its CDMO activities with manufacturing agreement for pivotal Phase II/III trial with initial value in the low single-digit millions of euros

FamiCord AG wins promising new client for its CDMO activities with manufacturing agreement for pivotal Phase II/III trial with initial value in the low single-digit millions of euros

• FamiCord CDMO division selected by VERIGRAFT to establish the GMP manufacturing process for personalized tissue-engineered vein P-TEV at its Warsaw site
• Approximately 18-month collaboration with an estimated contract value in the low single-digit millions of euros and the potential for further extension
• Agreement adds pivotal Phase II/III program to FamiCord's CDMO activities; trial expected to begin Q1 2027

Leipzig, 24 September 2026 – FamiCord AG, Europe's leading cell bank and the third largest worldwide, today announced that its CDMO brand “Bramble Bio”, under which the Group aggregates its CDMO activities, has entered into a manufacturing agreement with Swedish clinical-stage biotechnology company VERIGRAFT AB. The agreement covers the transfer and establishment of the manufacturing process for VERIGRAFT's lead product candidate P-TEV, as well as support for the sourcing and qualification of donated human vein tissue used as starting material for P-TEV manufacturing. The collaboration supports preparations for the pivotal Phase II/III trial TECVI-2 and further expands FamiCord's CDMO activities.

Technology-transfer activities to Bramble Bio's GMP site in Warsaw, Poland, will begin immediately. The Company will perform the process transfer, manufacturing preparation and related GMP activities required to supply the 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 the progress of the clinical program, patient recruitment and the associated manufacturing requirements.

“The agreement with VERIGRAFT marks another concrete step in the development of our CDMO activities,” Jakub Baran, CEO of FamiCord AG, explains. “Supporting a pivotal Phase II/III program requires close technical cooperation, rigorous process control and reliable cross-border logistics. The project broadens our portfolio with a late-stage clinical program and underlines the capabilities we have built at our Warsaw site.”

TECVI-2 is a randomized, controlled, open-label Phase II/III pivotal clinical trial, TECVI-2, designed to assess the efficacy of P-TEV in a larger patient population. Clinical sites are planned in Spain, Poland and the Netherlands. The trial is currently authorized in Spain, under the EU Clinical Trials Regulation, and approval in Poland and the Netherlands is expected Q4 2026.  TECVI-2 is expected to start in Q1 2027, and will evaluate P-TEV as a potentially curative treatment for patients suffering from severe chronic venous insufficiency (CVI). The trial is intended to support future marketing authorization applications in Europe and the United States.

“Establishing a robust and scalable manufacturing capability is fundamental to the successful delivery of TECVI-2 and to the future development of P-TEV. Bramble Bio combines specialist ATMP manufacturing expertise with the flexibility and commitment required for a complex, personalized therapy,” Petter Björquist, CEO of VERIGRAFT, adds. “We look forward to working closely with their team as we transfer our process and prepare to supply this important multi-country clinical trial.”

P-TEV is a personalized, fully biological tissue-engineered vein with a functioning valve, being developed for patients with severe CVI. The therapy starts 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 requiring immunosuppressive treatment.

Simon Boa, Managing Director of Bramble Bio, sees the project as a sweet spot deal for the company. “Technology transfer and clinical manufacturing for a personalized tissue-engineered product require close technical collaboration, rigorous process control and carefully coordinated logistics. These are core areas of expertise for our CDMO team.” Bramble Bio supports biotechnology and pharmaceutical companies with technology transfer, process development and optimization, GMP manufacturing, cellular starting-material sourcing, analytical services and international logistics. In addition to Warsaw, Bramble Bio operates a GMP site in Cantanhede, Portugal.

Further information on FamiCord and its subsidiaries can be found at www.famicord.com.

Contact: 
FamiCord AG
Ingo Middelmenne
Head of Investor Relations
Phone: +49 (0174) 9091190
Email: ingo.middelmenne@famicord.com

Company profile

FamiCord (formerly Vita 34) was founded in Leipzig in 1997 and today is by far the leading cell bank in Europe and the third largest worldwide. As the first private umbilical cord blood bank in Europe and a pioneer in cell banking, the company has since offered the collection, logistics, processing and storage of stem cells from umbilical cord blood, umbilical cord tissue and other postnatal tissues as a full-service provider for cryopreservation. The donor's own cells can either be used directly as a medicine or serve as valuable starting material for medical cell therapy and are kept alive in the vapor of liquid nitrogen. Customers from about 50 countries have already provided for the health of their families with around 1.5 million units of stored biological material at FamiCord. In addition, FamiCord has been expanding its CDMO activities focused on cell and gene therapies, leveraging its established laboratory infrastructure, GMP expertise and long-standing experience in handling human biological materials. This business complements the Group's recurring storage revenues and provides exposure to the rapidly growing ATMP market. As a result, FamiCord increasingly combines the stability of a leading cell banking platform with growth opportunities in advanced cellular medicine.

 Further information on VERIGRAFT can be found at www.verigraft.com

Contact: 
VERIGRAFT
Petter Björquist
Chief Executive officer
Phone: +46 (070) 5979296
Email: petter.bjorquist@verigraft.com

Company profile

VERIGRAFT is a biotechnology company based in Gothenburg, Sweden. The company is rooted in the Karolinska Institute, based on groundbreaking basic science with a focus on regenerative medicine since 2014.

VERIGRAFT has grown to become a forerunner in industrialized tissue engineering and advanced regenerative medicine. The company has a strategically focused R&D pipeline of personalized tissues, targeting areas such as cardiovascular and neuronal disease. VERIGRAFT will commercialize a series of personalized tissue-engineered grafts on a global market. Current and future products will help millions of patients with today uncurable diseases, severely impacting quality of life and putting numerous patients out of work or into disability programs.

VERIGRAFT’s headquarters are located close to Gothenburg University and Sweden´s biggest university hospital in central Gothenburg. Here the company has state-of-the-art preclinical laboratories and offices. VERIGRAFT is led by a team of experienced scientists and entrepreneurs, and is backed by investors from Europe, Asia and the US.