MONTREAL, November 12, 2024 – ExCellThera Inc. (ExCellThera), a world leader in blood stem cell expansion and fitness, announced today several UM171 presentations, including new UM171 Cell Therapy (INN/USAN-dorocubicel) data on long-term follow-up post transplantation and on TP53 mutated and EVI1 rearranged high-risk blood cancers, at the 66th American Society of Hematology Annual Meeting & Exposition (ASH), taking place December 7-10, 2024, in San Diego, California. The abstracts are now available on the ASH website at www.hematology.org/meetings/annual-meeting/abstracts.
ASH 2023 presentation details:
| Title: | Long Term Follow up of UM171 Expanded Cord Blood Transplantation Patients Does Not Reveal Any Late Toxicity |
| Date & Time: | Monday, December 9, 2024, 6:00 – 8:00 PM (Pacific Time) |
| Location: | San Diego Convention Centre, Halls G-H |
| Session: | 723. Allogeneic Transplantation: Long-term Follow-up, Complications, and Disease Recurrence: Poster III |
| Presenter: | Sandra Cohen, MD, FRCP, Maisonneuve Rosemont Hospital, Montreal |
| Title: | UM171 Cord Blood Transplantation for TP53 Mutated and EVI1 Rearranged Myelodysplasia/Acute Myeloid Leukemia |
| Date & Time: | Saturday, December 7, 2024, 5:30 – 7:30 PM (Pacific Time) |
| Location: | San Diego Convention Centre, Halls G-H |
| Session: | 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster I |
| Presenter: | Sandra Cohen, MD, FRCP, Maisonneuve Rosemont Hospital, Montreal |
| Title: | Development of a UM171-Supported, CD33 Epitope-Engineered Blood Stem Cell Graft for Advanced AML Therapies |
| Date & Time: | Sunday, December 8, 2024, 6:00 – 8:00 PM (Pacific Time) |
| Location: | San Diego Convention Centre, Halls G-H |
| Session: | 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster II |
| Presenter: | Bernhard Lehnertz, PhD, ExCellThera Inc., Montreal |
| Title: | UM171 Expands Immature Bone Marrow CD34+ Cells of Patients with Telomere-Biology Disorders |
| Date & Time: | Sunday, December 8, 2024, 6:00 – 8:00 PM (Pacific Time) |
| Location: | San Diego Convention Centre, Halls G-H |
| Session: | 509. Bone Marrow Failure and Cancer Predisposition Syndromes: Congenital: Poster II |
| Presenter: | Carvalho VS, Universidade de São Paulo, Ribeirão Preto, São Paulo |
About UM171 Cell Therapy
UM171 Cell Therapy (INN/USAN-dorocubicel), developed by Cordex Biologics, a wholly owned subsidiary of ExCellThera, has been evaluated in 120 patients with hematologic malignancies in clinical trials in the United States, Europe and Canada. UM171 Cell Therapy has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA.
UM171 Cell Therapy has successfully completed Phase 2 trials in patients with high and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with refractory or active disease, patients requiring a second transplant, and patients with TP53 mutations or other genetic abnormalities. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.
Earlier this year, a Market Authorisation Application (MAA) for UM171 Cell Therapy was accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for adult patients with hematological malignancies requiring a stem cell transplant who lack a readily available suitable donor.
The use of UM171 Cell Therapy in other patient populations, including patients with multiple myeloma, pediatric patients, and patients with non-malignant hematological diseases, is also being explored.
UM171 Cell Therapy is an investigational cell therapy, and its safety and efficacy have not been established by the FDA, EMA, Health Canada or any other health authority.
About ExCellThera
ExCellThera is a world leader in enhanced blood stem cell expansion. ExCellThera’s proprietary EnhanceTM platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding HSCs from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with biopharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the EnhanceTM platform, including the proprietary molecule UM171 which has a first- and best-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit excellthera.com, and follow us on LinkedIn.
