Gamida Cell Ltd. (NASDAQ: GMDA) was founded in 1999 and is headquartered in Jerusalem, Israel. It has 53 full-time employees (6/30/2018). It is a clinical-stage biopharmaceutical company that uses its proprietary technology to develop and treat cancer. And cell therapy for rare and serious blood diseases.
Gamida Cell Ltd. (GMDA):
Although cell therapies have the potential to treat various diseases, they are limited by the availability of donor cells, the matching of the donor and the patient, and the decline in the functionality of the donor cells when the cells are expanded to reach a therapeutic dose. Gamida Cell Ltd. has developed a series of products using nicotinamide (or NAM)-based cell expansion technology to address the limitations of cell therapy. Gamida Cell’s proprietary technology is designed to promote the proliferation of donor cells while maintaining the functional therapeutic properties of the cells.
Gamida Cell Ltd’s most advanced product candidate, NiCord , is a NAM-expanded cord blood cell therapy, which is expected to become a universal therapeutic stem cell transplant for patients in need of hematopoietic stem cell transplantation (HSCT).
Gamida Cell is currently conducting key phase III clinical trials for 120 patients with various hematological malignancies, including high-risk leukemias, such as acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), Chronic Myeloid Leukemia (CML), Myelodysplastic Syndrome (MDS) and Lymphoma. It is expected that the best data from this test will be reported in the first half of 2020. In Gamida Cell’s phase I/II clinical trials, patients transplanted with NiCord achieved rapid implantation and immune reconstitution, which are key indicators of clinical trials.
According to the company’s Phase I/II clinical trial results, Gamida Cell received NiCord’s Breakthrough Therapy Designation in the United States from the U.S. Food and Drug Administration (FDA). In addition, NiCord has received orphan drug designation from the FDA and the European Medicines Agency.
In addition to hematological malignancies, Gamida Cell is also seeking to develop NiCord for the treatment of bone marrow failure. NiCord is currently being evaluated in a phase I/II clinical trial sponsored by the National Institutes of Health, which is used in patients with severe aplastic anemia, a rare life-threatening Blood diseases. This study aimed to evaluate the safety and effectiveness of NiCord transplantation to overcome the high incidence of transplant rejection in severe aplastic anemia associated with conventional cord blood. The company expects to report preliminary data from phase I/II clinical trials in 2019.
In addition to NiCord, Gamida Cell is also using its NAM technology to develop another product candidate, NAM-NK, which is used in the innate immunotherapy of expanded natural killer cells (NK cells) in combination with standard therapeutic antibodies. NK cells have effective anti-tumor properties and have advantages over other tumor cell therapies that do not require genetic matching. When combined with certain antibodies, NK cells may become a universal donor-based therapy. NAM-NK addresses the key limitation of the therapeutic potential of NK cells by increasing the cytotoxicity and in vivo retention and proliferation of NK cells expanded under culture conditions. NAM-NK is currently conducting an investigator-funded phase I trial for the treatment of relapsed or refractory non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).
Gamida Cell Ltd. (GMDA) investment:
Gamida Cell Ltd. (NASDAQ:GMDA) submitted its IPO prospectus on 9/28/2018 and listed on NASDAQ on 10/26/2018. The planned issue price is US$13.00-15.00, the actual issue price is US$8, and 6,250,000 shares will be issued. , Raised US$50 million, underwritten by BMO Capital Markets/ RBC Capital Markets.