Will Gamida Cell's NiCord Strike A Chord?

(RTTNews) - Shares of Gamida Cell Ltd. (GMDA) are up nearly 15% this month while the iShares Nasdaq Biotechnology ETF index (IBB) is down 1.55% for the same period.

Israel-based Gamida Cell is a clinical-stage biopharmaceutical company developing novel cell therapies for difficult-to-treat cancers and rare, serious hematologic diseases. The Company's investigational products are based on its proprietary nicotinamide-based cell expansion technology, or NAM technology.

Umbilical cord blood (UCB) is a readily available source of stem cells for patients who need hematopoietic stem cell transplantations (HSCT), and can be used for the treatment of various life-threatening diseases, such as hematological malignancies or genetic blood disorders, in such cases where a matched related stem cell donor is not available. However, the major drawback of using this valuable stem cells source is the limited cell dose in a single cord blood unit (CBU), which may delay engraftment of the donor cells and reconstitution of the immune system. This, in turn, increases both time in the hospital and the likelihood that a patient might contract a life-threatening infection.

Gamida Cell's NAM technology is designed to overcome the limitations of cord blood as a source of donor cells, and introduce a paradigm shift to HSCT, by causing metabolic reprogramming, leading to cell proliferation while preserving stem cells.

The lead product candidate is NiCord, a NAM-expanded cell therapy with the potential to serve as a universal, curative bone marrow transplant for patients who do not have an available matched donor.

NiCord is under phase III registration study for *allogeneic transplantation in patients with hematologic malignancies in the United States, Europe and Asia. When stem cells are collected from a matching donor and transplanted into the patient, it is known as allogeneic transplantation.

The study, designed to enroll 120 patients with various hematologic malignancies, including high risk leukemias such as acute myeloid leukemia, or AML, acute lymphocytic leukemia, or ALL, chronic myeloid leukemia, or CML, myelodysplastic syndrome, or MDS and lymphomas, is expected to complete enrollment in the second half of 2019.

New translational data for NiCord is scheduled to be presented on December 1, 2018.

The Company expects top-line data from the phase III trial of NiCord to be reported in the first half of 2020.

NiCord is also under a phase I/II trial for the treatment of severe aplastic anemia. Preliminary data from this trial is expected to be reported in 2019.

Also in the pipeline is another product candidate, NAM-NK, which is currently in an investigator-sponsored phase I trial for the treatment of relapsed or refractory non-Hodgkin lymphoma, and multiple myeloma.

The Company reported encouraging preliminary data from the first two patients with non-Hodgkin lymphoma treated in the phase I study of NAM-NK in June 2018, with additional preliminary data to be reported next year.

The Company went public on the Nasdaq Global Market on October 26, 2018, offering its shares at a price of $8.00 each. GMDA has thus far hit a low of $7.99 and a high of $11.56. The stock closed Wednesday's (Nov.21) trading at $11.47, up 16.57%.