NEW YORK, July 01, 2019
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Company has entered a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for Y-mAbs within its existing facilities, at which both clinical and commercial supply of radiolabelled omburtamab can be produced.
Omburtamab is in a pivotal Phase II trial for the treatment of CNS/LM from neuroblastoma, a Phase I trial for the treatment of Diffuse Intrinsic Pontine Glioma (“DIPG”), and a Phase I for the treatment of Desmoplastic Small Round Cell Tumours (“DSRCT”). The Company expects to file a biologics license application (“BLA”) for omburtamab for the treatment of CNS/LM from neuroblastoma during 2019.
“The agreement with SpectronRx is designed to secure clinical and commercial scale radiolabeling capacity for omburtamab, and to allow us to supply the US market upon potential FDA approval of omburtamab. The facility will also serve as back-up for the Company’s overseas activities,” stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
Dr. Claus Moller, Chief Executive Officer continued, “We see great potential in radiopharmaceuticals, and we are excited to begin our collaboration with SpectronRx. We believe SpectronRx has the necessary expertise within radiolabeling of monoclonal antibodies to be a great partner supporting our launch strategy for omburtamab.”
Y-mAbs is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including two pivotal-stage product candidates—naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, respectively.