On April 18, 2023 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that a poster presentation featuring preclinical data on naxitamab, a recombinant, humanized anti-GD2 monoclonal antibody will be presented at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which takes place in Orlando, Florida from April 14-19, 2023 (Press release, Y-mAbs Therapeutics, APR 18, 2023, View Source [SID1234630264]). The poster, "Investigational novel humanized anti-GD2 antibody inhibits GD2-mediated immunosuppression by targeting GD2+ breast cancer stem-like cells," will be presented on April 18, 2023, from 1:30 to 5:00 pm EST.
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The disialoganglioside GD2 has been shown to be upregulated in triple-negative breast cancer ("TNBC") and its high expression is associated with a poor prognosis. Furthermore, breast cancer stem-like cells ("BCSCs") are reported to be a major contributing factor for metastatic spread of TNBC and contribute to chemotherapy resistance, making them an important target for therapeutic intervention. Currently, there are no available therapeutic tools for targeting BCSCs. New preclinical data from M.D. Anderson Cancer Center demonstrate that TNBC with high GD2 expression inhibits immune cell infiltration and that naxitamab targets GD2+ BCSCs and may be able to inhibit the growth of BCSCs by enhancing macrophage-mediated phagocytosis, NK cell-mediated ADCC, and T cell-mediated cytotoxicity.
Y-mAbs provided naxitamab (DANYELZA) to this pre-clinical investigator sponsored study ("ISS") at M.D. Anderson Cancer Center as part of its strategy to continue to support ISS studies.
Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.
About DANYELZA (naxitamab-gqgk)
DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved in the United States by the FDA under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information (View Source) for complete Boxed Warning and other important safety information.