On November 4, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported four presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held in Atlanta, Georgia or virtually from December 11-14, 2021 (Press release, Gamida Cell, NOV 4, 2021, View Source [SID1234594527]).
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New data on omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, will be presented during an oral presentation showing that hematopoietic stem cell transplantation with omidubicel is associated with robust immune constitution and lower rates of severe infection compared to standard umbilical cord blood transplantation. Additionally, there will be three poster presentations and one e-publication highlighting additional clinical data from omidubicel and GDA-201, the company’s natural killer (NK) cell immunotherapy in development for the treatment of hematologic and solid tumors with standard of care antibody therapies. Together the data that will be presented at ASH (Free ASH Whitepaper) reflect the progress across Gamida Cell’s NAM-enabled pipeline of cell therapies being developed as potentially curative approaches for cancer patients in need of new and better therapeutic options.
Details about the ASH (Free ASH Whitepaper) presentations are as follows:
Title: Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation (Oral)
Abstract Number: 333
Lead Author: Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA
Time: Saturday, December 11, 2021, 4:00 p.m. – 5:30 p.m. EST (session time) and 4:30 p.m. EST (presentation)
Title: Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center (Poster)
Abstract Number: 1827
Lead Author: Chenyu Lin, M.D., Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC
Time: Saturday, December 11, 2021, 5:30 p.m. – 7:30 p.m. EST
Title: GDA-201, a Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-Year Survival and Correlation with Cytokine IL7 (Poster)
Abstract Number: 3854
Lead Author: Veronika Bachanova, M.D., Ph.D., Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST
Title: Hospitalization and Healthcare Resource Use of Omidubicel Vs Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial (Poster)
Abstract Number: 4036
Lead Author: Navneet Majhail, M.D., Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST
Title: Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201) (e-Publication)
Abstract Number: 4791
Lead Author: Dima Yackoubov, M.Sc., Gamida Cell, Jerusalem, Israel
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition1. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.