Zemcelpro® (UM171 Cell Therapy) licensing and supply agreements announced for Europe
- Partnership advances the global commercialization strategy for Zemcelpro® (dorocubicel), also known as UM171 Cell Therapy, following its conditional marketing authorisation in Europe from the European Commission.
- Exclusive licensing and supply agreements grant Avanzanite commercialization rights for Zemcelpro® across 32 countries covering the European Economic Area, the United Kingdom and Switzerland.
MONTREAL, Nov. 9, 2026 /PRNewswire/ -- ExCellThera Inc. ("ExCellThera"), a global leader in blood stem cell expansion and metabolic fitness technologies and parent company of Cordex Biologics ("Cordex"), today announced that Cordex has entered into exclusive licensing and supply agreements granting Avanzanite Bioscience B.V. ("Avanzanite") commercialization rights for Zemcelpro® (dorocubicel), also known as UM171 Cell Therapy, across 32 countries covering the European Economic Area, the United Kingdom and Switzerland.
Zemcelpro® is a novel personalized cryopreserved hematopoietic stem cell transplantation product containing two cellular components: UM171-expanded CD34+ cells (dorocubicel); and unexpanded CD34- cells, each derived from the same cord blood unit. The product is used to treat haematological malignancies (blood cancers), such as leukemias and myelodysplasias. It is indicated in the European Union for the treatment of adult patients with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no suitable donor is available.
"These agreements with Avanzanite represent an important milestone in bringing Zemcelpro® to patients across Europe with significant unmet medical needs and advancing our global commercialization strategy," said David Millette, CEO of Cordex. "Avanzanite's pan-European presence and expertise in rare disease treatment launches and market access make it a strong strategic fit for Cordex. We look forward to working closely with their team to expand patient access to Zemcelpro®."
Avanzanite is a next-generation specialty pharmaceutical company focused on rare diseases.
"This partnership reflects why Avanzanite was founded: to unlock the full potential of innovative medicines for patients with rare diseases," said Adam Plich, Co-Founder and CEO of Avanzanite Bioscience. "We share Cordex's commitment to bringing Zemcelpro® to patients with blood cancers who have an urgent need for allogeneic transplant and no other suitable treatment options available to them."
Cordex continues to actively pursue additional strategic partnerships to support and accelerate the commercialization of Zemcelpro® in the U.S. and other international markets.
The transaction includes development fees, commercial milestone payments and royalties, creating a shared economic interest in the product's long-term commercial success and supporting the funding of the planned Phase 3 trial evaluating Zemcelpro® in patients with high- and very high-risk acute leukemias and myelodysplastic syndromes. The trial is intended to generate confirmatory evidence of efficacy and safety and support a potential indication expansion.
Avanzanite will lead regulatory activities, market access, pricing and reimbursement, medical affairs, commercial operations and distribution across the licensed territories. Following completion of the regulatory transfer, Avanzanite will become the holder of the existing EU marketing authorisation for Zemcelpro®. Avanzanite also plans to submit marketing authorisation applications in the United Kingdom and Switzerland.
Cordex will continue to lead global development of Zemcelpro® and will be responsible for the manufacturing and supply of Zemcelpro® to Avanzanite.
About Zemcelpro®
Zemcelpro® (dorocubicel), also known as UM171 Cell Therapy, is a novel personalized cryopreserved haematopoietic stem cell transplantation product developed by Cordex, containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.
Zemcelpro® received conditional marketing authorization from the European Commission for the treatment of adults with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation following myeloablative conditioning, for whom no other suitable donor cells are available. For complete product information, including warnings and precautions for use and adverse reactions (and their appropriate management), please refer to the EU Summary of Product Characteristics (SmPC) for Zemcelpro®.
Additional regulatory filings are planned for Zemcelpro® with other health authorities, including in the US, Canada, the UK, and Switzerland.
Zemcelpro® has been evaluated in over 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro® has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and PRIority MEdicines (PRIME) designation from the EMA.
Zemcelpro® has been tested in Phase 2 trials in patients with high- and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.
The use of Zemcelpro® in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being investigated.
For more information, visit zemcelpro.com.
Zemcelpro® is a registered trademark of Cordex or its related companies.
About Avanzanite Bioscience
Avanzanite is a next-generation pharmaceutical company purpose-built to unlock the full potential of rare disease medicines across Europe. Founded in 2022 and headquartered in Amsterdam, the Netherlands, Avanzanite was created around a belief that scientific innovation creates patient impact only when medicines reach those who can benefit from them. Through tailored partnerships, biopharma innovators entrust Avanzanite with the European future of their medicines. Avanzanite combines pan-European expertise, bold commercial and access strategy, together with high-performance execution, to transform Europe's complexity into opportunity, ensuring no patient is left behind and creating lasting long-term value for partners. For more information, visit www.avanzanite.com.
About ExCellThera and UM171 Technology
ExCellThera is a world leader in enhanced blood stem cell therapies. ExCellThera's proprietary EnhanceTM platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding haematopoietic stem cells (HSCs) from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with biopharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the EnhanceTM platform, including the proprietary molecule UM171 which has a first-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit excellthera.com, and follow us on LinkedIn.
SOURCE ExCellThera
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