Germany Fast-Tracks Novel Cell Therapy for High-Risk Blood Cancers

MONTREAL, Feb. 16, 2026 – A groundbreaking cell therapy for patients with life-threatening blood cancers has been granted a crucial fast-track reimbursement status in Germany, a move that promises immediate access for individuals who have exhausted other treatment options. The decision marks a significant step forward in the fight against aggressive hematological malignancies and a major commercial milestone for the therapy’s developer.

On Tuesday, Montreal-based ExCellThera Inc. announced that its innovative treatment, Zemcelpro® (dorocubicel), has achieved Status 1 listing under Germany's NUB program (Neue Untersuchungs- und Behandlungsmethoden). This designation allows German hospitals to immediately apply for temporary, supplementary reimbursement for the therapy, effectively opening a vital access route for a patient population with profound unmet needs.

For adults with certain high-risk leukemias and myelodysplasias, an allogeneic hematopoietic stem cell transplant (HSCT) can be the only curative option. However, the procedure relies on finding a suitably matched donor, a hurdle that leaves many without a viable path forward. Zemcelpro®, also known as UM171 Cell Therapy, was specifically developed to address this gap.

A Lifeline for Patients with No Other Options

The NUB program is designed to bridge the gap between innovation and patient access. Germany's standard hospital funding, based on a Diagnosis Related Groups (DRG) system, often fails to adequately cover the cost of novel, high-cost treatments. NUB Status 1 recognizes that a therapy is not only new but also supported by sufficient clinical evidence to warrant special, case-by-case funding negotiations between hospitals and sickness funds.

The demand within the German medical community is palpable. According to ExCellThera, 220 hospitals across the country have already expressed interest in using the NUB mechanism to provide Zemcelpro® to their patients in 2026. This widespread interest underscores the urgency and the perceived value of the therapy among front-line clinicians treating these complex diseases.

"NUB Status 1 represents a significant milestone for ExCellThera and Cordex and reflects both the innovative nature of Zemcelpro® (dorocubicel) and its benefit in addressing a pressing unmet medical need in allogeneic haematopoietic stem cell transplantation," said David Millette, CEO of ExCellThera, in a press statement. "Under its initial label, Zemcelpro® (dorocubicel) is indicated for patients with life threatening blood cancers who have limited therapeutic options."

This German decision follows the European Commission's granting of conditional marketing authorization for Zemcelpro® in August 2025, which validated its potential for patients requiring an allogeneic HSCT for whom no other suitable donor cells are available.

The Science Behind the Breakthrough

Zemcelpro® is not just another treatment; it represents a fundamental advance in stem cell technology. It is a personalized product derived from a single unit of cord blood, which is a rich source of hematopoietic stem cells but is often limited by a low cell count, making it unsuitable for many adult patients.

ExCellThera's proprietary Enhance™ platform, powered by the small molecule UM171, overcomes this critical limitation. The technology allows for the ex vivo expansion of stem cells, multiplying the number of functional, engraftable cells to a therapeutic dose. The final product, Zemcelpro®, contains two components: the UM171-expanded CD34+ cells (the therapeutic stem cells) and the remaining unexpanded cells from the original cord blood unit.

This expansion capability makes it possible to use smaller, better-matched cord blood units, increasing the pool of potential donors for patients from diverse ethnic backgrounds who often struggle to find a match in adult registries. The clinical evidence gathered to date is compelling. In trials involving 120 patients with high-risk blood cancers, Zemcelpro® demonstrated a 67% overall survival rate and a 63% progression-free survival rate. Crucially, the rate of relapse was a low 19%, and the incidence of moderate-to-severe chronic graft-versus-host disease (GVHD), a common and dangerous complication of transplantation, was only 7%.

A real-world analysis comparing patients who received Zemcelpro® to a control group from an observational database further bolstered these findings, showing a significant improvement in survival free from both relapse and chronic GVHD.

A Blueprint for Global Commercialization

For ExCellThera and its subsidiary Cordex Biologics, the NUB status in Germany is a key piece of a larger global strategy. It provides a crucial commercial foothold in Europe's largest pharmaceutical market and serves as a blueprint for navigating the complex reimbursement landscapes of other nations.

The NUB pathway is a temporary bridge. While it allows for immediate revenue and patient access, the ultimate goal is to secure long-term, statutory reimbursement within the standard German healthcare system. To achieve this, Cordex will work with German transplant centers to support their NUB applications while simultaneously investing in post-market registries. This will generate the real-world evidence and economic data required to prove the therapy's long-term value to regulators and payers.

This multi-pronged approach is being mirrored in the company's broader expansion plans. Regulatory filings are already in the works for the United States, Canada, the United Kingdom, and Switzerland. The therapy has already garnered significant attention from global regulators, receiving Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. FDA, as well as PRIME designation from the European Medicines Agency—all programs designed to expedite the review of promising therapies for serious conditions.

To fuel this expansion, Cordex is actively seeking strategic partnerships to accelerate the commercial rollout of Zemcelpro® across Europe and other key international markets. The company is engaging directly with national health authorities to establish early access programs where possible, ensuring that the regulatory green light translates into tangible patient benefit as quickly as possible.

As required by its conditional EU approval, a pivotal Phase 3 trial is set to be initiated soon to confirm the therapy's benefits in a larger patient population. The company is also exploring the use of its UM171 technology in other areas, including pediatric applications and the treatment of non-malignant hematological diseases, signaling a broad and ambitious future for this powerful stem cell expansion platform.