#Canada #Montreal #ExCellThera #Zemcelpro® #Medexus

ExCellThera and Medexus Partner to Introduce Zemcelpro® in Canada

In a significant step for blood cancer treatment, ExCellThera Inc. has announced exclusive licensing and supply agreements with Medexus, granting the latter marketing rights for Zemcelpro® (dorocubicel), also known as UM171 cell therapy, in Canada. This collaboration hopes to address the pressing medical needs of Canadian patients suffering from hematological malignancies.

Zemcelpro® represents a novel approach to hematopoietic stem cell transplants, integrating two essential elements: CD34+ cells multiplied through UM171 and non-multiplied CD34- cells, both derived from the same umbilical cord blood donation. This innovative therapy aims to offer a new treatment option for severe blood cancers such as leukemia and myelodysplastic syndromes.

The announcement, made on June 11, 2026, follows a conditional market authorization granted by the European Commission. However, in Canada, Medexus does not anticipate bringing Zemcelpro® to market before 2028, pending regulatory approvals from Health Canada.

David Millette, CEO of Cordex Biologics, emphasized the importance of these agreements, stating they mark a crucial milestone in advancing Zemcelpro® for patients facing significant medical challenges. He expressed hope that this partnership with Medexus will enhance access to innovative treatments for Canadian patients in urgent need of therapeutic alternatives.

Medexus, a leading specialty pharmaceutical company with extensive experience in hematology and oncology, is well-positioned to manage the commercialization of Zemcelpro®. The financial structure of the agreement includes royalties based on net sales in Canada as well as milestone payments, thereby aligning economic interests in the long-term success of the product.

ExCellThera's advancing strategies aim not only at the Canadian market but also at expanding the presence of Zemcelpro® across Europe and other international markets. The company continues to seek strategic partnerships to bolster its global market strategy.

Zemcelpro® has already undergone evaluations among over 120 patients with hematological tumors across clinical trials in the United States, Europe, and Canada. The therapy has received orphan drug designation from the FDA, along with advanced therapy designation (RMAT), and similar recognition from the EMA. These designations are critical, as they provide the necessary support for the expedited development and review of treatments for patients facing life-threatening conditions.

This therapy is especially aimed at patients with acute leukemias and high-risk myelodysplastic syndromes, where treatment options are extremely limited, and the prognosis is generally poor. A pivotal Phase III clinical trial is expected to launch promptly to further assess the therapy's efficacy within this vulnerable patient population.

In addition, investigations into the application of Zemcelpro® for other patient demographics, including children and those with non-malignant hematological disorders, are also underway. The safety and effectiveness of this therapy have yet to be confirmed by regulatory bodies such as the FDA and Health Canada.

In summary, the partnership between ExCellThera and Medexus signals a promising advancement in the treatment landscape for patients with severe blood cancers in Canada. With the ongoing commitment to innovation and research in cellular therapies, the healthcare community remains hopeful for impactful advancements that meet urgent patient needs. As regulatory discussions proceed, the focus remains on delivering transformative therapies that can significantly improve the quality of life and survival rates for these patients.