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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.
Selected Publications and Presentations
2023
Nicotinamide enhances natural killer cell function and yields remissions in patients with non-Hodgkin lymphoma
Science Translational Medicine 2023 July
Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials
Transplantation and Cellular Therapy 2023 May
Tumor Microenvironment Spatial Analysis after Adoptive NK Cell Therapy for Lymphoma Revealed Cross-Talk with Adaptive T-Cell Immunity
2023 Tandem Meetings of the ASTCT and CIBMTR
GDA-201: A Cryopreserved, Readily Available Formulation of Nicotinamide-Enabled Natural Killer Cells, Shows High Potency and Cytotoxicity In Vitro
2023 Tandem Meetings of ASTCT and CIBMTR
Longitudinal Immune Reconstitution Profiling Suggests Anti-Viral Protection After Transplantation With Omidubicel: A Phase 3 Substudy
2023 Tandem Meetings of ASTCT and CIBMTR
2022
Clinical outcomes following allogeneic hematopoietic cell transplantation (HCT) with omidubicel or other donor sources in patients with hematologic malignancies
Presented at the 64th Annual Meeting of the American Society of Hematology
Gamida Cell Presents New Data Demonstrating Promising Antitumor Activity Against HER2+ Cancers at SITC 37th Annual Meeting
Engineered NAM-NK cells with HER2-CAR expression demonstrate increased cytotoxicity against HER2-expressing solid tumors
Presented at the Society for Immunotherapy of Cancer's 37th Annual Meeting
Gamida Cell Presents New Data Demonstrating Improved and Sustained Health-Related Quality of Life Outcomes for Patients Treated with Omidubicel at the Society of Hematologic Oncology Meeting
Health-Related Quality of Life Following Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel Versus Standard Umbilical Cord Blood
Presented at the Tenth Annual Meeting of the Society of Hematologic Oncology
Gamida Cell Presents New Data Demonstrating Overall Survival and Sustained Long-Term Outcomes for Patients Treated with Omidubicel at the Society of Hematologic Oncology Meeting
Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials
Presented at the Tenth Annual Meeting of the Society of Hematologic Oncology
Gamida Cell Data Reports Omidubicel Leads to Robust Recovery and Diversity of T cells at 2022 Cord Blood Connect Meeting
Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Leads to Robust Recovery and Diversity of T cells
Presented at the 2022 Cord Blood Connect Meeting
Gamida Cell Presents Data Demonstrating the Impact of Transplantation with Omidubicel for Patients with Hematologic Malignancies at 2022 Cord Blood Connect Meeting
Health-Related Quality of Life Following Transplantation with Omidubicel Versus Umbilical Cord Blood in Patients with Hematological Malignancies: Results from a Phase III Randomized, Multicenter Study
Presented at the 2022 Cord Blood Connect Meeting
Gamida Cell Presents Data Demonstrating Projected Impact of Omidubicel on Racial and Ethnic Disparities at 2022 Cord Blood Connect Meeting
Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the US
Presented at the 2022 Cord Blood Connect Meeting
Gamida Cell Presents New Data on NAM-Enabled Genetically Modified Natural Killer Cell GDA-601 at ISCT 2022
NAM-NK Cell GDA-601 With CD 38 Knockout Expresses Enhanced CD38 Chimeric Antigen receptor and targets Multiple Myeloma Cells With Increased Cytotoxicity
Presented at the 2022 International Society for Cell & Gene Therapy
Gamida Cell Presents New Data on NAM-Enabled Genetically Modified Natural Killer Cell GDA-301 at ISCT 2022
Engineered NAM-NK Cell GDA-301 via CISH Knockout Membrane-Bound IL-15 Expression Increase Cytotoxicity Against Malignancies
Presented at the 2022 International Society for Cell & Gene Therapy
Gamida Cell Presents Updated One-Year Follow Up Data from Phase 3 Study of Omidubicel at TCT 2022
Hematopoietic Stem Cell Transplantation with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells, NK Cells and CD4+ T Cells with Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation
Presented at the 2022 Transplantation & Cellular Therapy Meetings of ASTCTand CIBMTR Tandem Meetings
Gamida Cell Presents Updated Omidubicel Data During Best Abstract Award Session at TCT 2022
Allogeneic Hematopoietic Stem Cell Transplant with Omidubicel Demonstrates Sustained Clinical Improvement Versus Standard Myeloablative Umbilical Cord Blood Transplantation
Presented at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings
AACR Advances in Malignant Lymphoma
Development of Nicotinamide Enhanced NK cell Therapeutics for Lymphoma
Presented at the 2022 Third International Meeting for AACR Advances in Malignant Lymphoma
2021
Shifting From T to NK Immunotherapy
PEGS 2021
Pioneering Next-Generation NK Cell Therapies
Gamida Cell 2021 Virtual R&D Day
Comparative effectiveness and safety of omidubicel versus other current allogeneic hematopoietic stem cell donor sources using network meta-analysis
Comparative effectiveness and safety of omidubicel versus other current allogeneic hematopoietic stem cell donor sources using network meta-analysis
AMCP Nexus 2021
Results of Omidubicel Phase 3 Clinical Study in Patients with Hematologic Malignancies Presented at EBMT
Improved Clinical Outcomes with Omidubicel versus Standard Myeloablative Umbilical Cord Blood Transplantation: Results of a Phase III Randomized, Multicenter Study
Presented at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021)
Results of Omidubicel Phase 3 Clinical Study in Patients with Hematologic Malignancies Presented at TCT
Improved Clinical Outcomes with Omidubicel versus Standard Myeloablative Umbilical Cord Blood Transplantation: Results of a Phase III Randomized, Multicenter Study
Presented at the 2021 TCT Meetings of ASTCT and CIBMTR
2020
Results of Omidubicel Phase 2 Clinical Study in Patients with Severe Aplastic Anemia Presented at ASH
Rapid Engraftment, Immune Recovery, and Resolution of Transfusion Dependence in Treatment-Refractory Severe Aplastic Anemia Following Transplantation with Ex Vivo Expanded Umbilical Cord Blood (Omidubicel)
Results of GDA-201 Phase 1 Clinical Study Presented at ASH
Results of a Phase 1 Trial of GDA-201, Nicotinamide-Expanded Allogeneic Natural Killer (NK) Cells in Patients with Refractory Non-Hodgkin Lymphoma and Multiple Myeloma
Observational Data Presented at Cord Blood Connect
Impact of Donor Age on HSCT Outcomes
NAM Mechanism of Action Data Presented at TCT
Nicotinamide (NAM) Modulates Transcriptional Signature of Ex Vivo Cultured UCB CD34+ Cells (Omidubicel) and Preserves Their Stemness and Engraftment Potential
Presented at the 2020 TCT Annual Meeting.
2019
Phase 1 Data on GDA-201 Presented at ASH
Results of a Phase 1 Trial of GDA-201, Nicotinamide-Expanded Allogeneic Natural Killer Cells (NAM-NK) in Patients with Refractory Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)
Presented at the 2019 ASH Annual Meeting.
Phase 1/2 Translational Data on Omidubicel Presented at TCT
Rapid and Robust CD4+ and CD8+ T-, NK-, B-Cell, Dendritic Cell, and Monocyte Reconstitution after Nicotinamide-Expanded Cord Blood Transplantation.
Presented at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and Marrow Transplantation (ASBMT) and Center for International Blood and Marrow Transplant Research (CIBMTR).
Phase 1 GDA-201 Data Presented at TCT
First-in-Human Phase I Study of Nicotinamide-Expanded Related Donor Natural Killer Cells for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma and Multiple Myeloma
Presented at the 2019 TCT Meetings of ASBMT and CIBMTR.
Initial Phase 1/2 Data on Omidubicel in Aplastic Anemia Presented at TCT
Ex Vivo Nicotinamide-Expanded (NAM-Expanded) Unrelated Cord Blood (UCB) Transplantation for Refractory Severe Aplastic Anemia Results in Rapid Engraftment and Expedites Immune Recovery
Presented at the 2019 TCT Meetings of ASBMT and CIBMTR.
Phase 1/2 Data on Omidubicel Published in JCO
Phase I/II Study of Stem-Cell Transplantation Using a Single Cord Blood Unit Expanded Ex Vivo with Nicotinamide
Journal of Clinical Oncology 2019 Feb 10;37(5):367-374.
2018
Phase 1 Data on GDA-201 Presented at AACR
Phase I Study of Nicotinamide-Expanded Related Donor Natural Killer (NK) Cells for the Treatment of Relapsed/Refractory CD20+ non-Hodgkin Lymphoma
Presented at the 2018 International Meeting on Advances in Malignant Lymphoma.
2017
ASH Presentation on Cell-Expansion Platform for NK Cells
Presented at the 2017 ASH Annual Meeting.
Phase 1/2 Omidubicel Data Presented at ASH
NiCord Single Unit Expanded Umbilical Cord Blood Transplantation (UCBT): Final Results of a Multicenter Phase I/ II Trial
Presented at the 2017 ASH Annual Meeting.
Omidubicel Clinical Outcomes Data Published in BBMT
Transplantation of Ex Vivo Expanded Umbilical Cord Blood (NiCord) Decreases Early Infection and Hospitalization
Biol Blood Marrow Transplant. 2017 Jul;23(7):1151-1157.
