#Canada #Montreal #Zemcelpro #ExCellThera #Medexus

ExCellThera and Medexus Announce Exclusive Licensing Agreements for Zemcelpro® in Canada

On June 11, 2026, ExCellThera Inc., a global leader in blood stem cell expansion technologies, announced a significant milestone in its product development journey. Partnering with its wholly-owned subsidiary, Cordex Biologics, ExCellThera has secured exclusive licensing and supply agreements allowing Medexus to market Zemcelpro® (dorocubicel) in Canada, pending approval from Health Canada.

Zemcelpro®, known as the cellular therapy UM171, is a groundbreaking personalized product derived from cryopreserved hematopoietic stem cells. It contains two key components: CD34+ cells expanded using the innovative UM171 technology and non-expanded CD34- cells, both sourced from the same umbilical cord blood unit. This promising product aims to target hematologic malignancies, such as leukemias and myelodysplastic syndromes, which are critical areas in oncology where new treatment options are desperately needed.

With the current status of product development in Canada, Medexus is looking at a timeline that may not see Zemcelpro® on the market until 2028, contingent on navigating the regulatory landscape effectively. Part of Medexus's strategy includes obtaining Health Canada’s approval for the Zemcelpro® brand. David Millette, CEO of Cordex, highlighted this agreement as a testament to their commitment to advance this innovative solution for patients facing severe unmet medical needs. He stated, “This partnership not only presents a robust commercial opportunity but also holds the potential to significantly improve access to innovative therapies for high-risk cancer patients across Canada.”

Medexus is recognized as a leading pharmaceutical company with extensive expertise in hematology and oncology, establishing it as a strong strategic partner for Cordex in this endeavor. The agreement also marks an important step in Cordex's global commercialization strategy for Zemcelpro®. The company is actively pursuing additional strategic alliances to expedite the marketing of Zemcelpro® across Europe and other international markets.

“The global interest in innovative therapies addressing ongoing unmet needs in hematological malignancies and conventional stem cell transplants is significant. Our focus remains on identifying partners with the necessary expertise, infrastructure, and shared vision to broaden patient access worldwide,” Millette continued. As discussions progress, Cordex's dedication to delivering transformative therapies remains at the forefront, aiming to provide urgent treatments while creating long-term value for its stakeholders.

The transaction includes net sales royalties in Canada and milestone payments, fostering a shared economic interest in the long-term commercial success of Zemcelpro®. Cordex will retain responsibility for clinical program management, as well as the manufacturing and supply of Zemcelpro® to Medexus.

About Zemcelpro®

Zemcelpro® (dorocubicel), described as a personalized product for hematopoietic stem cell transplantation, utilizes both expanded CD34+ cells with UM171 and non-expanded CD34- cells, sourced from the same umbilical cord blood. Recently, Zemcelpro® received conditional marketing authorization from the European Commission for adult patients requiring allogeneic hematopoietic stem cell transplants following myeloablative conditioning, where no suitable donor cells are otherwise available. For detailed product information, including warnings, precautions, and adverse reactions, interested parties should reference the EU Product Characteristics Summary (SmPC) for Zemcelpro®.

Moreover, further regulatory procedures are anticipated for Zemcelpro® in additional health authorities, including the USA, Canada, the UK, and Switzerland. The product has undergone evaluation in more than 120 patients with hematological malignancies across clinical trials in the USA, Europe, and Canada. The FDA has designated Zemcelpro® as an orphan drug, and as a regenerative medicine advanced therapy (RMAT), while the EMA has assigned orphan drug status, classified it as an advanced therapy medicinal product (ATMP), and designated it as Priority Medicines (PRIME).

Zemcelpro® has been explored in phase 2 trials for patients with acute leukemias and high-risk myelodysplastic syndromes, characterized by limited treatment options, low survival rates, and high relapse rates with current standard treatment. Future pivotal phase 3 trials for this patient population are planned to commence promptly.

Additionally, the application of Zemcelpro® is being investigated for other patient populations, including pediatrics and those with non-malignant hematological conditions. Importantly, the safety and efficacy of the product have yet to be established by regulatory agencies, such as the FDA, MHRA, and Health Canada.

About ExCellThera

ExCellThera stands as a pioneer in enhancing blood stem cell therapies. Through its patented Enhance™ platform tailored for cellular expansion and metabolic optimization, it aims to deliver a greater dose of functional therapeutic stem cells by scaling up hematopoietic stem cells from any origin while counteracting the stresses induced by culturing or genetic editing. The company collaborates with biopharmaceutical firms to develop cutting-edge cellular and gene therapies utilizing the Enhance™ technologies, including the proprietary UM171 compound with its novel mechanism for ex vivo expansion and metabolic optimization of stem cells. For more information, visit excellthera.com and follow the company on LinkedIn.

Zemcelpro® is a registered trademark of Cordex or its affiliated entities.

For investor and media inquiries, please contact Jean Proulx at [email protected]