ExCellThera and Avanzanite Forge Licensing Agreements for Zemcelpro® in Europe

ExCellThera and Avanzanite Partner for Zemcelpro® in Europe

ExCellThera Inc., a global frontrunner in the expansion of blood stem cells and metabolic fitness technologies, has announced a significant milestone in its strategic growth with the establishment of licensing and supply agreements with Avanzanite Bioscience B.V. This partnership grants Avanzanite exclusive marketing rights for Zemcelpro® (Dorocubicel), also known as UM171 cell therapy, across 32 countries in Europe, including the European Economic Area, the United Kingdom, and Switzerland.

Zemcelpro® represents a groundbreaking, personalized, cryopreserved product designed for hematopoietic stem cell transplantation. This innovative therapy comprises two cellular components: UM171-expanded CD34+ cells (Dorocubicel) and non-expanded CD34- cells, both sourced from the same umbilical cord blood unit. It is primarily indicated for treating hematological malignancies such as leukemia and myelodysplastic syndromes in adult patients who require allogeneic stem cell transplantation following myeloablative conditioning and lack suitable donor cells.

David Millette, CEO of Cordex Biologics, a subsidiary of ExCellThera, emphasized the importance of this agreement, stating that it aims to improve patient access to Zemcelpro® across Europe, addressing an urgent medical need. He noted that Avanzanite's extensive European presence and expertise in launching therapies for rare diseases make it a highly strategic partner.

Avanzanite is a next-generation specialty pharmaceutical company focused on rare diseases. Adam Plich, Co-founder and CEO of Avanzanite, expressed his enthusiasm about the partnership, aligning with their vision of delivering innovative medications to patients needing allogeneic transplantation options.

Through these agreements, ExCellThera seeks to enhance the commercialization of Zemcelpro® in the US and other international markets as well. The arrangement also involves development fees, milestone payments upon commercial success, and royalties that secure a mutual economic interest in the long-term success of the product. This financial structure will support the planned Phase 3 study aimed at evaluating Zemcelpro® for patients with acute leukemias and high-risk myelodysplastic syndromes, which intends to provide conclusive evidence of its efficacy and safety.

Avanzanite will take charge of regulatory activities, market access strategies, pricing, reimbursement, medical affairs, commercial operations, and distribution within the licensed territories. Following the completion of the regulatory transfer, Avanzanite will become the holder of the existing EU authorization for Zemcelpro® and plans to submit applications for market authorization in the UK and Switzerland as well.

Meanwhile, Cordex will continue to oversee the global development of Zemcelpro® and will be responsible for its manufacturing and supply. This collaboration lays a strong foundation for the future of the Zemcelpro® therapy, which has already demonstrated its potential in clinical studies across the US, Europe, and Canada, having been evaluated in over 120 patients with hematological malignancies.

Zemcelpro® is designated by the FDA as an 'Orphan Drug' and is classified as a 'Regenerative Medicine Advanced Therapy' (RMAT). The European Medicines Agency (EMA) has also granted it 'Orphan Medicine' designation, 'Advanced Therapy Medicinal Product' (ATMP) classification, and 'Priority Medicines' (PRIME) status.

The therapy has been under investigation in Phase 2 clinical trials for patients with acute leukemias and myelodysplastic syndromes who face limited treatment options under current standard therapies.

ExCellThera's proprietary Enhance™ platform, specifically using the UM171 compound, aims to revolutionize blood stem cell therapies by optimizing cell expansion and metabolic function. This ambition places ExCellThera at the forefront of advancing health care solutions for patients in need of cutting-edge treatment for blood-related disorders.

For further information about Zemcelpro®, you can visit zemcelpro.com. More information on Avanzanite can be found at avanzanite.com.