MONTRÉAL, October 20, 2020 – ExCellThera Inc., a clinical-stage molecular medicine company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that it has received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency (EMA) for ExCellThera’s most advanced technology, ECT-001 Cell Therapy.
The EMA issues ATMP classifications to new medicines for human use that are based on genes, tissues or cells and offer groundbreaking new opportunities for the treatment of disease and injury. The ATMP program supports medicine developers in achieving market authorization by providing guidance in preclinical development, manufacturing and product quality testing, as well as incentives for regulatory advice, recommendations and evaluation.
“We are extremely pleased that the EMA has granted ECT-001 Cell Therapy with ATMP classification,” said Dr. Guy Sauvageau, CEO and founder of ExCellThera. “We look forward to working with the EMA under this designation to secure market access and ensure ECT-001 Cell Therapy will be made available to a far greater number of severely ill patients.”
The ECT-001 technology, comprised of the UM171 small molecule and an optimized culture system, is used in novel curative blood transplant therapies for patients with blood cancers and disorders. Currently, ECT-001 is being evaluated in several Phase I/II clinical trials for severe blood disorders in Canada and the United States. ECT-001 Cell Therapy has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designation from the U.S. Food and Drug Administration and orphan medicinal product designation from the European Medicines Agency.
About ExCellThera Inc.
ExCellThera is a clinical-stage cell and molecular medicine company delivering molecules and bioengineering solutions to expand stem and immune cells for use in novel one-time curative therapies for patients with hematologic malignancies and other diseases. ExCellThera’s most advanced technology, ECT-001 Cell Therapy, combines a proprietary small molecule, UM171, and an optimized culture system. In pursuit of better treatments for patients, the company is building out its portfolio of products, as well as supporting best-in-class clinical trials. excellthera.com