WEP Clinical (WEP) is pleased to announce a new partnership with Y-mAbs Therapeutics, Inc. (Y-mAbs), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. Together, WEP and Y-mAbs, will make DANYELZA® (naxitamab-gqgk) 40mg/10mL Injection available to patients contingent on meeting the eligibility criteria in Europe through a Named Patient Program (NPP) subject to receiving local approval.
DANYELZA® is a humanized, monoclonal antibody that binds to the glycolipid GD2. GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. DANYELZA® is administrated on days 1, 3, and 5, of each treatment cycle as an intravenous infusion after dilution. Treatment cycles are repeated every 4 weeks until complete response or partial response, following by 5 additional cycles every 4 weeks. It was developed by researchers at Memorial Sloan Kettering Cancer Center (MSK) and is exclusively licensed by MSK to Y-mAbs.
In the US, DANYELZA® is approved by the FDA and 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.
More details can be requested about DANYELZA® Named Patient Program by emailing danyelzanpp@wepclinical.com.
Jas Khera, Managing Director of WEP, said:
“We are excited to be able to work with Y-mAbs to provide access to DANYELZA® to patients in Europe initially.”
About WEP
At WEP Clinical, we are With Every Patient, as we believe every patient should have access to treatment! With this as our leading principle, we have created a market leading, solutions driven, healthcare services company that partners with drug developers to create broader treatment access for patients worldwide. We take pride in the high-quality output and positive customer experience we create while delivering our services. We specialize in the following: Expanded Access and Post-Approval Named Patient Programs; Market Access Solutions; Home Nursing Services for Decentralized Clinical Trials; and Clinical Trial Sourcing. For more information, please visit www.wepclinical.com.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company’s product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3.
