#None #Zemcelpro #ExCellThera #Avanzanite

ExCellThera and Avanzanite Collaborate on Zemcelpro® Licensing Agreements

On November 9, 2026, ExCellThera Inc., a global leader in blood stem cell expansion technologies, announced significant licensing and supply agreements regarding its innovative product, Zemcelpro® (dorocubicel), also known as the UM171 cell therapy. This collaboration with Avanzanite Bioscience B.V. marks a pivotal step towards increasing patient access to this cutting-edge treatment in Europe.

Zemcelpro® is a state-of-the-art cryopreserved therapeutic specifically designed for hematopoietic stem cell transplantation. It comprises two cellular elements: expanded CD34+ cells utilizing UM171 (dorocubicel) and unexpanded CD34− cells, both sourced from the same cord blood unit. The product addresses unmet medical needs for patients suffering from hematologic malignancies, such as leukemia and myelodysplastic syndromes (MDS).

Following the European Commission granting conditional marketing authorization for Zemcelpro®, Avanzanite has secured exclusive rights to market this therapy in 32 countries, including those within the European Economic Area, the United Kingdom, and Switzerland.

David Millette, CEO of Cordex Biologics (a subsidiary of ExCellThera), emphasized the significance of this collaboration, stating, "These agreements with Avanzanite represent a crucial milestone to making Zemcelpro® accessible to patients across Europe with significant unmet medical needs. Avanzanite’s pan-European presence and expertise in launching treatments for rare diseases make them an ideal strategic partner. We look forward to closely collaborating with their team to expand patient access to Zemcelpro®."

Avanzanite, a next-generation pharmaceutical company focused on rare diseases, shares a commitment to making Zemcelpro® available to patients who urgently require allogeneic stem cell transplantation but lack suitable donor options. Adam Plich, co-founder and CEO of Avanzanite, stated, "This partnership embodies Avanzanite’s mission to unlock the full potential of innovative drugs for patients with rare diseases. We are united with Cordex in our drive to ensure access for patients with blood cancers in need of niche treatments."

The agreement also outlines development milestone payments and royalties, highlighting a shared economic interest in the long-term commercial success of Zemcelpro®. This collaboration will contribute to funding a phase 3 trial aimed at evaluating Zemcelpro® among patients with acute leukemia and high-risk myelodysplastic syndromes. The trial is designed to produce data validating the product's efficacy and safety, supporting potential future indication extensions.

Avanzanite will oversee regulatory activities, market access, pricing and reimbursement issues, medical affairs, commercial activities, and distribution across the licensed territories. Upon completing regulatory transfer, Avanzanite will take ownership of the existing marketing authorization for Zemcelpro® in the European Union. They also plan to file marketing authorization requests in the UK and Switzerland.

While Avanzanite manages the EU market aspect, Cordex continues to lead the global development of Zemcelpro® and will be responsible for its manufacturing and supply to Avanzanite.

About Zemcelpro®

Zemcelpro® has an innovative cryopreserved design and is specifically tailored for hematopoietic stem cell transplantation. It is currently indicated in the EU for adult patients with hematological malignancies needing allogeneic stem cell transplants following myeloablative conditioning, particularly when no suitable donor is available.

Zemcelpro® is backed by clinical evaluations involving over 120 patients with malignancies across trials in the US, Europe, and Canada. It has achieved orphan drug designation and regenerative medicine advanced therapy (RMAT) designation from the FDA, as well as orphan drug designation and advanced therapy medicinal product (ATMP) classification from the EMA.

The product has undergone thorough assessment in phase 2 trials for patients facing acute leukemias and high-risk myelodysplastic syndromes, all characterized by limited treatment options and low survival rates.

For more information about Zemcelpro®, please visit zemcelpro.com.

Company Backgrounds

Avanzanite Bioscience: Founded in 2022 and based in Amsterdam, Avanzanite is committed to harnessing the full potential of drugs targeting rare diseases across Europe. Through customized partnerships, they aim to ensure that innovative scientific advancements reach the patients who need them.

ExCellThera: A leader in enhanced blood stem cell therapies and the developer of the exclusive Enhance™ platform designed for optimizing cell functionality, ExCellThera aims to empower biopharmaceutical collaborations to develop cutting-edge cellular and gene therapies.

Through the innovative approaches of both companies, Zemcelpro® is set to improve the landscape of treatment options for patients facing critical blood disorders.