On April 25, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported that updated infection data on omidubicel in comparison to umbilical cord blood transplantation (UCB), was shared in an oral presentation at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022 (Press release, Gamida Cell, APR 25, 2022, View Source [SID1234612927]).

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The presentation, which received a TCT Best Abstract Award, titled "Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation," was presented by Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA. The data from a sub-study of the Phase 3 randomized trial of omidubicel showed early and enhanced recovery of variety of immune cells, including circulatory dendritic cell subtypes, NK cells and CD4+ T cells within the first 28 days and sustained B-cell recovery from Day 28 onwards, and such immune recovery was associated with lower rates of severe infection. The data from an additional analyses of CD4+ subsets, T-cell receptor repertoire diversity and recent thymic emigrants support the long-term durability and functionality of the omidubicel graft.

"These data provide mechanistic support for the reduced infection rates seen with omidubicel-treated patients in the Phase 3 study, and clear demonstration of the benefits of omidubicel over standard cord blood transplantation, which can be associated with immune and hematopoietic recovery challenges that are devastating to patients," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "As we advance omidubicel through the FDA review process, these data demonstrate that the therapy has the potential to change the outlook for patients suffering from blood cancer, who all too often struggle with post-transplant recovery complications."

Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.

In total, Gamida Cell is presenting two oral and six poster presentations at TCT 2022. All poster presentations are publicly available at www.ASTCT.org.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status and orphan drug designation by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). For more information on clinical trials of omidubicel, please visit the Gamida Cell website.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we are able to enhance, expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.