Our R&D

PIPELINE

We’re enabling the next generation of cancer cell therapy.

We are developing a proprietary pipeline of NAM-enabled cell therapies with the potential to redefine standards of care across a range of diseases where there is an urgent medical need. Explore our pipeline below for information on our clinical development candidates and ongoing clinical trials.

  • PRODUCT
  • DISCOVERY
  • PHASE 1
  • PHASE 2
  • PHASE 3

Omidubicel

Hematologic Malignancies
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PHASE 3
Severe Aplastic Anemia
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PHASE 2

Gda-201

Non-Hodgkin Lymphoma
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PHASE 2
Non-Hodgkin Lymphoma
Trial 2
PHASE 1

GDA-301

Solid Tumors
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CISH KO + membIL-15
DISCOVERY

GDA-401

Solid Tumors
Genetically Engineered
DISCOVERY

GDA-501

Solid Tumors
HER2 CAR
DISCOVERY

GDA-601

Multiple Myeloma
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CD38 KO + CD38 CAR
DISCOVERY

PLATFORM

Gamida Cell is pioneering a diverse approach to cellular therapy that utilizes nicotinamide (NAM) to expand multiple cell types — including stem cells and natural killer (NK) cells — while maintaining their original phenotype and potency. When applied to umbilical cord blood–derived cells in the production of our investigational omidubicel product for allogeneic stem cell transplant, NAM-enabled cells have improved clinical measures such as engraftment time and infection rate, potentially leading to better outcomes for patients.

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 NAM expansion that yields highly functional NK cells. These cells have demonstrated ability to kill cancerous cells in both animal models and clinical trials, and are being developed in both unmodified and genetically engineered forms.

Selected Publications and Presentations

2022

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 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 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 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 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 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

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 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 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

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

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 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

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)

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.