We are offering an improved, genetically modified version of Unituxan (dinutuximab), an approved monoclonal antibody (mAb) targeting the disialoganglioside GD2. This improved antibody therapeutic has a significantly better tolerance profile and is known as hu14.18K322A.
Neuroblastoma is the most common extracranial solid tumor in childhood. Hu14.18K322A used in standard therapy resulted in improved survival rates in patients with high-risk disease. Patients with high risk neuroblastoma who had at least a partial response to standard induction chemotherapy and were randomly assigned to receive the antibodies combined with cytokines and isotretinoin in the maintenance phase had longer event-free and overall survival compared with those who received isotretinoin alone. Similarly, in an update of the Cooperative German Neuroblastoma Trials, patients who received hu14.18K322A had better long-term outcomes.
Neuroblastoma, mAbs, GD2, neuroblastoma, antibodies, anti-GD2 Ab, Unituxin, dinutuximab
Granted Patents or Published Applications
Related Scientific References
Brian C. Tse, MD, Fariba Navid, MD, Catherine A. Billups, MS, Thomas O’Donnell, MD, and Mary E. Hoehn, MD; “Ocular abnormalities in patients treated with a novel anti-GD2 monoclonal antibody, hu14.18K322A” Journal of AAPOS (American Association for Pediatric Ophthalmology and Strabismus.); http://dx.doi.org/10.1016/j.jaapos.2014.11.005
Fariba Navid, Paul M. Sondel, Raymond Barﬁeld, Barry L. Shulkin, Robert A. Kaufman, Jim A. Allay, Jacek Gan, Paul Hutson, Songwon Seo, KyungMann Kim, Jacob Goldberg, Jacquelyn A. Hank, Catherine A. Billups, Jianrong Wu, Wayne L. Furman, Lisa M. McGregor, Mario Otto, Stephen D. Gillies, Rupert Handgretinger, and Victor M. Santana, “Phase I Trial of a Novel Anti-GD2 Monoclonal Antibody, Hu14.18K322A, Designed to Decrease Toxicity in Children With Refractory or Recurrent Neuroblastoma” Journal of Clinical Oncology, Vol. 32, #14, 5/10/2014.
Federico SM, McCarville MB, Shulkin BL, Sondel PM, Hank JA, Hutson P, Meagher M, Shafer A, Ng CY, Leung W, Janssen WE, Wu J, Mao S, Brennan RC, Santana VM, Pappo A, Furman WL. A pilot trial of humanized anti-GD2 monoclonal antibody (hu1418K322A) with chemotherapy and natural killer cells in children with recurrent/refractory neuroblastoma. Clin Cancer Res. 2017 Sep 22;PubMed PMID: 28939747.
Talleur AC, Triplett B, Federico S, Mamcarz E, Janssen W, Shook D, Leung W, Furman WL. Consolidation therapy for newly diagnosed pediatric neuroblastoma patients using busulfan/melphalan, autologous hematopoietic cell transplant anti-GD2 antibody, GM-CSF, IL-2 and allogeneic NK cells. Biol Blood Marrow Transplant. 2017 Jul 18. PMID: 28733263
Furman W, Federico SM, McCarville M, Shulkin B, Davidoff A, Krasin MJ, Sahr N, Sykes A, Wu J, Brennan R, Bishop M, Helmig S, Stewart S, Navid F, Triplett B, Santana V, Bahrami A, Anthony G, Yu A, Jank J, Gillies S, Sondel P, Leung W, Pappo A. A phase II trial of hu14.18K322A in combination with induction chemotherapy in children with newly diagnosed high-risk neuroblastoma. Clin Cancer Res. 2019 Nov 1;25(21):6320-6328. PMID: 31601569
Nguyen R, Sahr N, Sykes A, Federico SM, Sooter A, Cullins D, Rooney B, Janssen W, Talleur A, Triplett B, McCarville MB, Anthony G, Dyer M, Pappo A, Leung W, Furman W. Longitudinal NK cell kinetics and cytotoxicity in children with neuroblastoma enrolled in a clinical phase II trial. J Immunother Cancer. 2020 Mar;8(1) PMID:32221013
Bishop MW, Hutson PR, Hank JA, Sondel PM, Furman WL, Meagher MM, Navid F, Santana VM. A Phase 1 and pharmacokinetic study evaluating daily or weekly schedules of the humanized anti-GD2 antibody hu14.18K322A in recurrent/refractory solid tumors.
Anghelescu DL, Goldberg JL, Faughnan LG, Wu J, Mao S, Furman WL, Santana VM, Navid F. Comparison of pain outcomes between two anti-GD2 antibodies in patients with neuroblastoma. Pediatr Blood Cancer. 2015 Feb;62(2):224-228. doi: 10.1002/pbc.25280. Epub 2014 Nov 8. PMID: 25382742
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