BOSTON, November 03, 2022–(COMMERCIAL WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), a leader in the development of NAM-enabled cell therapy candidates for patients with solid and hematologic cancers and other serious diseases, today announced an oral presentation of a real-world analysis comparing the effectiveness of omidubicel with other allo – HCT donor sources from the Center for International Blood and Marrow Transplantation Research (CIBMTR) database. These data are presented in the 64the Annual meeting of the American Society of Hematology (ASH), to be held in New Orleans on December 10-13, 2022.
“Data from our Phase 3 study compared the safety and efficacy of omidubicel to standard umbilical cord blood. We are delighted to have the opportunity, in a podium presentation at ASH, to share the work we have done with CIBMTR, exploring its expanding real-world database and performing the first comparative efficacy analyzes between omidubicel and other donor sources for patients undergoing allogeneic stem cell transplantation,” said Ronit Simantov, MD, chief medical and scientific officer of Gamide Cell. “These data reinforce the clinical relevance of the rapid time to neutrophil engraftment observed in omidubicel transplant patients and support the potential use of omidubicel in patients with hematologic malignancies requiring transplantation. We are diligently preparing to bring this important therapy to patients.” before the possibility of FDA approval.”
Details about the ASH filing are as follows:
Title: Clinical Outcomes Following Allogeneic Hematopoietic Cell Transplantation With Omidubicel or Other Donor Sources in Patients With Haematological Malignancies: Comparison of Clinical Trial Results With Controls from the International Center for Blood and Marrow Transplantation Research Database
Session Title: 732. Allogeneic Transplantation: Comparative Treatment and Disease Response Studies: Clinical Outcome: Real World Studies Based on Database Analysis
Primary author: Smitha Sivaraman, PhD.
Weather: Saturday, December 10, 2022, 2:00 pm to 3:30 pm EST (session time) and 2:30 pm EST (presentation time)
Location: Ernest N. Morial Convention Center, 391 – 392
A prospective cohort analysis study is presented to compare the efficacy of omidubicel against other donor sources of allo-HCT (MUD, MMUD and haploidentical) used in clinical practice. The study compared data from the omidubicel (n=52) and control (n=56) arms of the phase 3 study with a cohort of similar patients derived from the CIBMTR database (n=807) who had undergone a transplant with matched unrelated donors, mismatched unrelated donors, or haploidentical donors. Analysis showed that omidubicel was associated with faster neutrophil recovery (median 10 days) compared to all other donor sources (median 15-20 days; p<0.001). Although platelet recovery took longer in the omidubicel cohort, the rates of severe acute and chronic graft-versus-host disease (GVHD) were comparable. Importantly, analyzes of non-relapse mortality, disease-free survival, and overall survival showed similar results among all donor sources. Although the phase 3 study compared omidubicel to standard umbilical cord blood, these real-world data reinforce the clinical utility of omidubicel as a graft source in patients requiring allogeneic stem cell transplantation.
Omidubicel is an advanced cell therapy candidate developed as a possible life-saving allogeneic hematopoietic (bone marrow) stem cell transplant in patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment compared to standard umbilical cord blood in an international, multicenter, randomized phase 3 study (NCT0273029) in patients with hematologic malignancies who underwent allogeneic transplantation of bone marrow. The phase 3 study also showed reduced time to platelet engraftment, reduced infections, and fewer hospital days. One year post-transplant data showed sustained clinical benefits with omidubicel as evidenced by significant reduction in infectious complications as well as reduction in non-relapse mortality and no significant increase in relapse rates or increases in disease rates. graft versus host disease (GVHD). . Omidubicel is the first source of stem cell transplant donors to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.
The BLA for omidubicel has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. If approved, omidubicel will be the first source of advanced allogeneic stem cell therapy donors for patients with blood cancers who need a stem cell transplant
Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, visit https://www.gamida-cell.com.
About NAM technology
Our NAM enabling technology is designed to enhance the number and functionality of target cells, allowing us to pursue a curative approach that goes beyond what is possible with existing therapies. By harnessing the unique properties of NAM (nicotinamide), we are able to metabolically expand and modulate multiple cell types, including stem cells and natural killer cells, with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. In addition, our NAM technology improves the metabolic fitness of cells, allowing continuous activity throughout the expansion process.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy line of potentially curative cell therapy candidates for patients with solid tumors and blood cancers and other serious blood diseases. We apply a proprietary expansion platform that harnesses the properties of NAM to allogeneic cell sources, including umbilical cord blood-derived cells and NK cells, to create candidate therapies with the potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of a bone marrow transplant, and a modified and unmodified NAM-enabled NK cell line targeting solid tumors and hematologic malignancies. For additional information, visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the timing of initiation and progress of clinical trials of Gamida Cell’s product candidates (including omidubicel ), regulatory submissions submitted to the FDA (including the potential timing of FDA’s review of the BLA for omidubicel), marketing planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including omidubicel), and Gamida Cell’s expectations for expected clinical development milestones set forth in this document. Any statement that describes Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered a statement of risk. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, including the scope, progress and expansion of clinical trials and ramifications. from Gamida Cell for the cost. of the same; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the effort to build a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on August 15, 2022, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and the actual results of Gamida Cell could differ materially and adversely from those anticipated or implied by them. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based solely on facts and factors currently known to Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
1CIBMTR 2019 – Allogeneic transplants in patients older than 12 years with hematological neoplasms.
twoGamida Cell Market Research
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