BOSTON–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced data evaluating the mechanism of action of nicotinamide (NAM)-enabled NK cells, demonstrating enhanced homing, cytotoxicity and tumor reduction by GDA-201, the lead candidate in its NAM-enabled NK cell therapy pipeline. The data will be presented at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021) taking place in Washington, DC, and virtually November 10-14, 2021.
The presentations identify network interactions between differentially expressed genes and intracellular metabolites associated with enhanced biological functional activity of GDA-201 NK. The data show that NAM increases cytotoxicity, ADCC, homing and in vivo antitumor activity of NK cells by modulating multiple metabolic pathways, down-regulating immune checkpoint inhibitors, increasing resistance to reactive oxygen species and influencing other cellular processes. An artificial intelligence–assisted analysis identified 1,204 differentially expressed genes, and 100 significantly modified metabolites, due to the effect of NAM. These data further validate the unique benefits of the NAM technology and its potential to improve clinical outcomes.
“NAM gives us a powerful tool for preserving and enhancing desirable qualities of NK cells and a broad range of other cell types. It has been shown to improve persistence and potency against cancer and may offer advantages in overcoming an immunosuppressive tumor microenvironment,” said Julian Adams, Ph.D., chief executive officer of Gamida Cell. “These data are helping us to better understand how our proprietary NAM technology platform produces these benefits as we continue to pursue clinical trials of GDA-201 and other NK cell therapies.”
Gamida Cell will present two posters at the conference, entitled “Cytotoxicity of nicotinamide (NAM)-enhanced natural killer (NK) cells (GDA-201) is based on metabolic modulation as demonstrated by artificial intelligence–assisted analysis of NK cell transcriptome and metabolome,” and “Nicotinamide (NAM) rejuvenates ex vivo expanded natural killer cells and enhances their tumor killing capacity.”
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) 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 https://www.gamida-cell.com.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapies with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please 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 timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cell’s product candidates, anticipated regulatory filings (including the submission of the BLA for omidubicel to the FDA), commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of omidubicel, and Gamida Cell’s expectations regarding its projected cash to be used for operating activities and cash runway. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. 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, and including the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost thereof; 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 endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, 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 Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
1 Bachanova, et al. ASH 2020. Abstract #63.