Zemcelpro® Receives NUB Status 1 in Germany for Blood Cancer Treatment
- A new therapy for life-threatening blood cancers has received a significant regulatory boost in Germany.
- The NUB designation is crucial because it allows German hospitals to immediately apply for temporary, supplementary reimbursement for Zemcelpro® while broader, long-term reimbursement pathways are being established.
- Zemcelpro®, also known as UM171 Cell Therapy, is a novel, personalized cell therapy designed for adults with haematological malignancies – cancers of the blood – who require allogeneic...
A new therapy for life-threatening blood cancers has received a significant regulatory boost in Germany. Zemcelpro® (dorocubicel), developed by ExCellThera Inc. And its subsidiary Cordex Biologics, has been granted Status 1 listing by the NUB (Neue Untersuchungs- und Behandlungsmethoden) program, as announced on .
The NUB designation is crucial because it allows German hospitals to immediately apply for temporary, supplementary reimbursement for Zemcelpro® while broader, long-term reimbursement pathways are being established. This is particularly important for patients with limited therapeutic options. Notably, hospitals across Germany have already expressed interest in accessing the therapy through this mechanism in .
What is Zemcelpro® and Who Might Benefit?
Zemcelpro®, also known as UM171 Cell Therapy, is a novel, personalized cell therapy designed for adults with haematological malignancies – cancers of the blood – who require allogeneic haematopoietic stem cell transplantation (allo-HSCT). Allo-HSCT involves receiving stem cells from a donor. However, finding a suitable donor can be a significant challenge for many patients. Zemcelpro® is specifically indicated for those patients for whom no other appropriate donor cells are available following myeloablative conditioning, a high-dose chemotherapy regimen used to prepare the body for the transplant.
The therapy itself is a cryopreserved product containing two key components: UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, both derived from the same cord blood unit. Cord blood is the blood remaining in the umbilical cord after birth and is a rich source of stem cells.
Recent Approvals and Ongoing Development
The NUB Status 1 listing follows recent conditional marketing authorization granted by the European Commission (EC) in . This EC authorization allows for the marketing of Zemcelpro® across the European Union, as well as in Iceland, Norway, and Liechtenstein. The EC decision recognizes Zemcelpro® as the first and only cell therapy specifically for blood cancer patients lacking access to suitable donor cells.
According to David Millette, CEO of ExCellThera, “NUB Status 1 represents a significant milestone… and reflects both the innovative nature of Zemcelpro® (dorocubicel) and its benefit in addressing a pressing unmet medical need in allogeneic haematopoietic stem cell transplantation.”
How Does Zemcelpro® Work?
Zemcelpro® aims to overcome the limitations of traditional stem cell transplantation by expanding the number of functional stem cells available for transplant. ExCellThera’s proprietary EnhanceTM platform, used to develop Zemcelpro®, focuses on both cell expansion and improving the metabolic fitness of the stem cells. This is designed to deliver a greater dose of cells capable of effectively rebuilding the patient’s blood and immune system.
The therapy has been evaluated in patients with haematologic malignancies in clinical trials across the United States, Europe, and Canada. It has received orphan drug designation and Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. Food and Drug Administration (FDA), as well as orphan medicinal product designation, Advanced Therapy Medicinal Product (ATMP) classification, and PRIME designation from the European Medicines Agency (EMA).
Future Plans and Accessibility
Cordex Biologics, the ExCellThera subsidiary responsible for Zemcelpro®, plans to work closely with leading German stem cell transplant centers to support individual NUB applications and expand clinical adoption. The company will also invest in post-market registry participation and data generation to support longer-term reimbursement and inclusion in clinical guidelines.
While currently approved in Europe, the availability of Zemcelpro® in individual countries will depend on the completion of national reimbursement procedures. Cordex is actively engaging with national health authorities to enable early access for eligible patients and is working to establish a network of treatment sites. Additional regulatory filings are planned with health authorities in the US, Canada, the UK, and Switzerland.
ExCellThera is actively seeking strategic partnerships to accelerate the commercialization of Zemcelpro® in Europe and other international markets. The company is also investigating the use of Zemcelpro® in other patient populations, including pediatric patients and those with non-malignant haematological diseases.
Zemcelpro® has been tested in Phase 2 trials in patients with high and very high-risk acute leukemias and myelodysplasias, including those with specific genetic mutations like TP53, patients requiring a second transplant, and those with refractory or active disease. A pivotal Phase 3 trial in this patient population is planned.
the safety and efficacy of Zemcelpro® have not yet been established by regulatory agencies such as the U.S. FDA, the MHRA, and Health Canada.