#Canada #Montreal #Zemcelpro #ExCellThera #Medexus

ExCellThera and Medexus Join Forces for Advanced Cancer Treatment in Canada

ExCellThera Inc., a prominent player in blood stem cell expansion technologies, has made a significant stride in the realm of cancer therapies by entering into exclusive licensing and supply agreements with Medexus Pharmaceuticals, granting Medexus the marketing rights to Zemcelpro® (dorocubicel) in Canada. This groundbreaking agreement is contingent upon necessary regulatory approvals from Health Canada.

Zemcelpro®, also referred to as UM171 cell therapy, is an innovative hematopoietic stem cell transplant product that contains two components: CD34+ cells, expanded using the proprietary UM171 technology, and non-expanded CD34− cells, sourced from the same umbilical cord blood unit. Designed to address hematological malignancies like leukemia and myelodysplastic syndromes, this therapy marks a notable evolution in personalized medicine, particularly for patients with limited treatment options.

Following its recent conditional marketing authorization from the European Commission, Zemcelpro® stands poised to impact the medical landscape significantly. Medexus's role in this partnership aims to navigate the Canadian market's complexities and advocate for the product's approval from Health Canada, projecting a marketing commencement no earlier than 2028. The urgency of making this therapy available stems from the existing unmet medical needs in the field of high-risk blood cancers, emphasizing the importance of bringing new treatment alternatives to patients in Canada.

David Millette, CEO of Cordex Biologics (a wholly owned subsidiary of ExCellThera), expressed optimism about the collaboration, stating, “This agreement is a crucial milestone that reflects our commitment to advancing Zemcelpro® for patients who have significant unmet medical needs.” He highlighted the dual benefits of potential economic opportunities and improved access to innovative therapies for Canadian patients requiring allogeneic stem cell transplants.

With an extensive portfolio focused on hematology and oncology, Medexus is strategically aligned for this partnership due to its well-established distribution capabilities in North America. The collaboration marks a pivotal step in Cordex's global marketing strategy for Zemcelpro®, as it seeks further strategic alliances to promote the product across European and other international markets.

Millette believes there is robust global interest in innovative therapies to fill existing treatment gaps for blood cancers and traditional stem cell transplant procedures. He further articulated, “We continue to seek partners with the necessary expertise and infrastructure, alongside a shared vision to expand patient access to treatments worldwide.” As these discussions progress, the priority remains clear: to deliver potentially life-altering therapies to patients who urgently require new options while creating long-term value for all stakeholders involved.

Economic Incentives and Future Plans

The agreement includes revenue-sharing on net sales in Canada and milestone payments, establishing a shared economic interest in the product's long-term commercial success. Cordex will oversee the clinical program and is responsible for the manufacturing and delivery of Zemcelpro® to Medexus.

Zemcelpro®'s mechanism of action is grounded in its unique composition and the innovative use of UM171 technology, which optimizes stem cell therapy and enhances metabolic fitness. A variety of international regulatory submissions are expected to follow, with plans for further submissions to health authorities in the US, UK, Canada, and Switzerland.

Clinical trials have demonstrated Zemcelpro®'s potential for patients with various hematological malignancies, particularly in scenarios where conventional treatment options are limited. Designed to address a spectrum of patients including those suffering from TP53 mutations and those requiring multiple transplants, the therapy is set to undergo further testing, including a pivotal Phase 3 study.

In addition to adult patients, the possibility of applying Zemcelpro® in pediatric patients and those with non-malignant hematological disorders is under exploration.

As ExCellThera, together with its partners, continues to advance its initiatives, the focus remains on developing cutting-edge therapies aimed at maximizing patient outcomes and addressing critical needs in healthcare. With these licensing and supply agreements, ExCellThera and Medexus are clearly contributing to a promising future where patients have access to novel therapies that could significantly alter their treatment trajectories and improve their quality of life.