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PIPELINE
We’re advancing potentially curative cell therapies for cancer.
Our proprietary nicotinamide (NAM) technology enhances and expands innate cells, offering potentially curative options for patients living with blood cancers. Explore our pipeline below for information on our clinical development candidates and ongoing clinical trials.
The safety and efficacy of GDA-201 and Omisirge™ (omidubicel-onlv) for aplastic anemia have not been established by the U.S. Food and Drug Administration or any other health authority.
- PRODUCT
- DISCOVERY
- PHASE 1
- PHASE 2
- PHASE 3
- REGISTERED
Omidubicel
Hematologic Malignancies
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Hematologic Malignancies
About Omisirge™ (omidubicel-onlv)
Omisirge™ (omidubicel-onlv) is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. It is the first and only allogeneic stem cell transplant therapy to be approved on the basis of a global, randomized Phase 3 clinical study (NCT02730299). For Full Prescribing Information and Boxed Warning, please visit omisirge.com.
Severe Aplastic Anemia
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Severe Aplastic Anemia
Omisirge is being evaluated in an ongoing investigator-sponsored Phase 1/2 study in patients with severe aplastic anemia. For more information about the study, please visit www.clinicaltrials.gov.
Gda-201
Non-Hodgkin Lymphoma
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Non-Hodgkin Lymphoma
About GDA-201
GDA-201 is an intrinsic natural killer (NK) cell therapy candidate being investigated for the treatment of hematologic malignancies in combination with standard of care antibody therapies. When combined with targeted antibodies, GDA-201 has shown enhanced antibody-dependent cellular toxicity, or ADCC. GDA-201 is expanded and enhanced by our proprietary nicotinamide (NAM) technology and uses intrinsic NK cells from a healthy donor, not induced pluripotent stem cell (iPSC)-derived cells. In April 2022, the U.S. Food and Drug Administration (FDA) approved the investigational new drug (IND) application for GDA-201. GDA-201 is in an ongoing Phase 1/2 clinical study for non-Hodgkin Lymphoma.
Clinical Trial Information
The study is a multi-center, open label trial evaluating the cryopreserved formulation of GDA-201. It is currently open to enrollment. The Phase 1 portion of the study is designed to evaluate the safety of GDA-201 in patients with non-Hodgkin lymphoma*. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in two patient cohorts, follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL). The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments. For more information about the study, please visit www.clinicaltrials.gov (NCT05296525).
GDA-201 has been evaluated in a Phase 1 investigator-led study in patients with refractory non-Hodgkin lymphoma (NHL), demonstrating that GDA-201 generally was well tolerated in 35 patients. Of the 19 patients with NHL, 13 complete responses and one partial response were observed (CRR = 68%, ORR = 74%). No dose-limiting toxicities were observed.
*Including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL), marginal zone lymphoma or mantle cell lymphoma.
Non-Hodgkin Lymphoma
Trial 2
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NAM Technology
Gamida Cell’s proprietary nicotinamide (NAM) technology expands the number of cells while maintaining their intrinsic properties, and enhances cellular functionality and phenotype. Our technology leverages the properties of NAM, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. For stem cells, this may mean improved homing and retention in bone marrow and lymph nodes, and increased metabolic fitness. For natural killer (NK) cells, NAM increases cytotoxic effects and resilience under oxidative stress.
NK cells are cytotoxic lymphocytes of the innate immune system capable of killing virally infected and/or cancerous cells, and can be engineered using CAR and gene editing to increase targeting and activation. After expansion in culture, however, NK cells typically lose some of their ability to traffic, localize and proliferate in vivo. This has been suggested as a major cause for the poor survival of adoptively transferred NK cells and their inability to overcome immune resistance in the tumor microenvironment. To address this obstacle, Gamida Cell has developed a reliable, scalable and GMP-compliant culture method for expansion by our proprietary NAM technology that yields highly functional NK cells. These cells have demonstrated ability to kill cancerous cells in both animal models and clinical trials.
OUR MANUFACTURING
Gamida Cell has a wholly owned, fully licensed GMP manufacturing facility.
