ExCellThera Inc., a clinical stage biotechnology company focused on bioengineering solutions to expand stem and immune cells for therapeutic use, has entered into a manufacturing and collaboration agreement with Comprehensive Cell Solutions (CCS), a division of New York Blood Center (NYBC) for the clinical grade production of ExCellThera’s lead cell therapy product, ECT-001.

ExCellThera will have access to NYBC’s cGMP clean room manufacturing facilities in New York for the production of ECT-001, to be used in clinical trials principally in the U.S. ExCellThera’s near term pipeline includes several ongoing studies and additional trials using ECT-001 to be initiated in the coming months. The agreement also provides further strategic collaboration between the companies.

The ECT-001 technology is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative blood transplant therapies for patients with blood malignancies and other diseases. The FDA has granted ECT-001 orphan drug designation for the prevention of graft-versus-host disease and regenerative medicine advanced therapy designation in the treatment of hematologic malignancies.

“The New York Blood Center holds one of the world’s largest blood banks and has over 50 years of leadership in research and development, medical services and laboratory services. We are extremely pleased to enter into this multi-year agreement which will allow us to work closer together and leverage their leadership and expertise in this specialized field,” said David Millette, chief operating and financial officer at ExCellThera. “ExCellThera expects a substantial scale-up in production to meet the needs of new trials coming online as ECT-001 advances through the final phases of its clinical development. This collaboration with NYBC will increase overall production capabilities by adding capacity to the existing manufacturing facilities in Montreal, Canada, while also providing redundancies, easing cross-border issues and providing further strategic collaboration opportunities.”

“We are proud to partner with ExCellThera as they work to create groundbreaking curative treatments for patients suffering from blood diseases. Their work has the potential to dramatically increase access to stem cells for patients who need them and unleash the therapeutic promise of the hundreds of thousands of cord blood units stored worldwide,” said Chief Medical and Scientific Officer at New York Blood Center, Dr. Beth H. Shaz. “New York Blood Center is the perfect fit for this endeavor.  With its facilities, in the heart of the city’s life sciences corridor, NYBC can collaborate with leading international biotechnology companies doing critical work to advance medical research. As the creators of the world’s first and largest public cord bank, we’re excited about the opportunity to leverage our experience to support such an important mission.”