Latest news with #CellTherapy
Cision Canada
4 days ago
- Health
- Cision Canada
Zemcelpro® (UM171 Cell Therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells Français
If approved, Zemcelpro ® is expected to: increase access to donor-derived stem cell transplantation, which offers a potentially curative option for haematologic malignancies, including leukemias and myelodysplastic syndromes be the first and only therapy in the European Union with marketing authorization for adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available Approval decision from the European Commission expected within approximately two months MONTREAL, June 19, 2025 /CNW/ - ExCellThera Inc. (ExCellThera), a world leader in blood stem cell expansion and metabolic fitness, announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending granting conditional marketing authorization for Zemcelpro ® for the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available. The European Commission (EC) is expected to make a final decision within approximately two months following CHMP recommendation, and the decision will apply to all 27 European Union (EU) Member States, Iceland, Norway and Liechtenstein. Zemcelpro ®, also known as UM171 Cell Therapy, is a novel cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit. If approved, Zemcelpro ® is expected to be the first and only therapy in the EU with marketing authorization for adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available. Every year in Europe there are over 10,000 new cases of patients with haematological malignancies, including leukemias and myelodysplastic syndromes, requiring bone marrow transplant, and a number of these patients do not have access to suitable donor cells for different reasons, including the absence or unavailability of suitably matched donors. The positive CHMP opinion was based on the conditional Marketing Authorization Application (MAA) for Zemcelpro ®. Additional filings are planned for Zemcelpro ® with other health authorities, including in the US, Canada, the UK, and Switzerland. "Each year, thousands of people in Europe are diagnosed with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation, and it's an upsetting reality that a number of them don't have access to suitable donor-derived stem cells," said Dr. Guy Sauvageau, CSO and Founder of ExCellThera. "With today's positive opinion, we are closer to bringing the life-changing potential of Zemcelpro ® to patients with at-risk haematological malignancies in the EU," said David Millette, CEO of ExCellThera. "We are proud to bring our transformative cell therapy innovation to patients who continue to have unmet medical needs." The safety of Zemcelpro ® is consistent with the well-characterized safety profile of conventional allogeneic blood stem cell transplantation for haematological malignancies following myeloablative conditioning. ExCellThera extends its sincere gratitude to the patients and investigators who have contributed to the clinical development of Zemcelpro ®. About Zemcelpro ® Zemcelpro ®, also known as UM171 Cell Therapy, is a novel cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit. Zemcelpro ®, developed by Cordex Biologics, a wholly owned subsidiary of ExCellThera, has been evaluated in 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro ® 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. Zemcelpro ® has been tested in 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 patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible. The use of Zemcelpro ® in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being explored. The product is not yet approved for marketing by the EMA and remains subject to European Commission decision. Its safety and efficacy have not been established by other regulatory agencies, such as the FDA and Health Canada. About ExCellThera and UM171 Technology ExCellThera is a world leader in enhanced blood stem cell therapies. ExCellThera's proprietary Enhance ™ platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding haematopoietic stem cells (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 Enhance ™ platform, including the proprietary molecule UM171 which has a first-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit and follow us on LinkedIn.
Yahoo
30-05-2025
- Business
- Yahoo
Intermountain Health first in nation to expand stem cell collection for CAR-T Cell Therapy bringing innovative cancer procedure to Southern Utah
ST. GEORGE, Utah (ABC4 Utah) – Intermountain Health is now offering a national first-of-its kind expansion of CAR-T Cell Therapy, bringing cutting-edge cancer care closer to patients in Southern Utah and Nevada. Intermountain's new CAR-T Cell satellite clinic in St. George marks a significant milestone to improve access to FDA approved CAR T-cell therapies at a regional clinic – and is the first time in the United States that CAR T-Cell collections are now available at a remote site away from a primary treatment center. Before expanding the CAR T-Cell therapy program, patients in southwest Utah, Nevada and beyond, had to travel hundreds of miles to Intermountain LDS Hospital in Salt Lake City for collection, transplant, and follow-up care. This innovative expansion of stem cell collection and CAR T-cell collection procedures at the Intermountain Health St. George Cancer Center provides advanced cancer treatment options closer to home for patients in the region. 'Expanding CAR-T Cell Therapy to Intermountain St. George Regional Hospital is a testament to our commitment to providing accessible, state-of-the-art cancer treatment,' said Brad Hunter, MD, medical oncologist and director of the CAR T-cell program at Intermountain LDS Hospital. 'This clinic will significantly enhance the quality of care for patients in Southern Utah and beyond our state boarders, offering them hope and healing without the need to travel long distances.' CAR-T Cell Therapy is a form of immunotherapy that harnesses the power of a patient's own immune system to fight cancer by genetically reprogramming T-cells to target and destroy cancer cells. 'This therapy has shown remarkable success in treating certain types of leukemia and non-Hodgkin lymphoma and we're grateful for the chance to make it more accessible,' said Dr. Hunter. This process is customized to each individual oncology patient and involves collecting the patient's immune cells or T cells, which are then sent to a different location and re-engineered. About two to three weeks later the patient will travel to Intermountain LDS Hospital for the re-programmed cells to be transplanted back to the patient. The new cells then target and kill the cancer cells by binding to the specific proteins or antigens on the cancer cells. The patient is observed to confirm the treatment is working and then sent home, with follow up appoints close to home. Jacqueline, 68, from Las Vegas, Nevada, received CAR-T therapy for her Non-Hodgkin's Lymphoma last year at Intermountain LDS Hospital and says it saved her life. 'It was really miraculous,' said Jacqueline. 'I could see the back of my throat and see the lymph nodes, so swelled up and then within two weeks of the treatment, suddenly, they were just gone. They even scanned me and everything was gone.' Jacqueline and her husband had to travel to Salt Lake numerous times and stay for a month, they say the new Intermountain Health St. George CAR-T Cell satellite clinic will save some miles and will be nice for future cancer patients to have treatment, 'just down the street.' CAR T-Cell therapy is currently FDA approved for patients who have a variety of hematologic cancers, including acute lymphoblastic leukemia (ALL), B-cell lymphomas, and multiple myeloma. For more information about the Intermountain Health CAR-T Cell Therapy program and services, go to Intermountain Health. Close Thanks for signing up! Watch for us in your inbox. Subscribe Now Sposored by Intermountain Health. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
