Gamida Cell - Cord Blood Transplant

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First Patient Successfully Transplanted with Cryopreserved (Frozen) NiCord® in Gamida Cell’s Ongoing Phase I/II Clinical Trial for Blood Cancers 

Jan. 8, 2015

This is the first transplantation to use a graft of ex-vivo expanded, cryopreserved, cord blood progenitor cells

Jerusalem, Israel, January 8, 2015 --- Gamida Cell, a leader in cell therapy technologies and products for transplantation and adaptive immune therapy, announced today that the first person has been successfully transplanted with cryopreserved (frozen) NiCord® in the company’s ongoing Phase I/II clinical study for blood cancer patients. This is the first time that a patient has been successfully transplanted with umbilical cord blood stem and progenitor cells, that were expanded (population increased) ex-vivo (outside of the body), and cryopreserved.  The company also noted today that after thaw, the cryopreserved product maintained the advantage of NiCord® in demonstrating very rapid engraftment (white blood cell recovery).  It is expected that this rapid engraftment will reduce the risk of opportunistic infections, will lower the morbidity associated with cord blood transplantation and shorten hospitalization.

“This is a significant technological milestone in the evolution of the development of NiCord®.  Moving forward,in all ongoing and future clinical trials, NiCord®will be used only in its cryopreserved formulation. Until now, NiCord®has been transplanted as a “fresh” product that must be infused into the patient within a limited number of hours from the moment the product is released from the manufacturing site. This timetable restricted the window for transplantation for the patient.  It also limited the location of manufacturing sites to the vicinity of participating medical centers and increased the cost of shipping and logistical support required from manufacturing through delivery.  To overcome these limitations, Gamida Cell developed a cryopreserved formulation of the product with a long shelf life,” said Dr. Yael Margolin, president and CEO of Gamida Cell.

Dr. Margolin continued, “The cryopreserved formulation of NiCord® provides several key benefits. It enables flexibility in the timing of a transplantation, which can now be determined according to the clinical conditions of the patient.   If a delay is required, it is now possible and more easily managed.  This flexibility in timetable also means that the product can now be distributed more efficiently and worldwide, enabling the company to expand its clinical trials to all geographic areas.   NiCord® can also now be manufactured in a preferable, centralized location, which will significantly reduce the cost of goods.”

NiCord® is currently manufactured and shipped to the US and Europe from Gamida Cell in Jerusalem.

NiCord® is derived from a single umbilical cord blood unit which has been expanded in culture and enriched with stem and progenitor cells using Gamida Cell’s proprietary NAM technology.  NiCord® is in development as an investigational therapeutic treatment for blood cancers such as leukemia and lymphoma and for non-malignant hematological diseases.  Clinical sites in the US, Spain, Italy, Israel and the Netherlands will collectively enroll 20 patients, with hematologic malignancies following myeloablative therapy, in the Phase I/II study of NiCord®, in a single cord configuration.  For more information about the achievements and benefits of NiCord® in a single cord configuration please click here.

About Gamida Cell

Gamida Cell is a world leader in cell therapy technologies and products for transplantation and adaptive immune therapy. The company’s pipeline of products are in development with a potential to treat a wide range of conditions including blood cancers, non-malignant hematological diseases such as sickle cell disease and thalassemia, neutropenia and acute radiation syndrome, autoimmune diseases, solid tumors and genetic metabolic diseases as well as conditions that can be helped by adaptive immune therapy such as solid and blood cancers refractory to chemotherapy.  Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood and peripheral blood, which are expanded in culture. Gamida Cell’s current shareholders include: Novartis, Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures.  For more information please visit www.gamida-cell.com.

Forward looking statement

All forward-looking statements in this announcement are based on information available to Gamida Cell as of the date hereof and Gamida Cell cannot guarantee such statements will materialize. Gamida Cell does not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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