NEW YORK, Dec. 21, 2022 (GLOBE NEWSWIRE) — 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, today announced that it has entered into a distribution agreement with WEP Clinical Ltd. (“WEP”) in connection with an early access program for DANYELZA (naxitamab-gqgk) 40mg/10mL Injection in Europe.
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 administered 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, followed by 5 additional cycles every 4 weeks.
In the U.S., 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.
“We are excited to be able to give European patients access to DANYELZA through this early access program with WEP,” said Thomas Gad, founder, President and Interim CEO. “Initially, DANYELZA will be available through such program in Spain and France, and we hope to add additional territories to the agreement.”
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.