NEW YORK, Dec. 12, 2019 (GLOBE NEWSWIRE) — 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 and immunotherapeutic products for the treatment of cancer, today announced that its GD2-GD3 Vaccine has been granted a Rare Pediatric Disease Designation (“RPDD”) by the FDA for the treatment of neuroblastoma.
The GD2-GD3 Vaccine was originally developed by researchers at Memorial Sloan Kettering (“MSK”), and licensed to MabVax Therapeutics Holdings, Inc. (“MabVax”), which sublicensed the compound for the treatment of neuroblastoma to Y-mAbs in 2018. Upon approval by the FDA of the GD2-GD3 Vaccine, Y-mAbs may be eligible for a Priority Review Voucher (“PRV”) and will share 20% of the net income received from the potential sale of such PRV with MabVax.
The GD2-GD3 Vaccine is being tested in a single center clinical trial at MSK where children with neuroblastoma, who are in remission, are being treated with seven subcutaneous injections during a year (ClinicalTrials.gov Identifier: NCT00911560) to prevent relapse.
“This Rare Pediatric Disease Designation is of great importance to Y-mAbs, which is now eligible for a PRV upon approval of the biologics license application (“BLA”) for this rare pediatric cancer. Among our three leading compounds, Y-mAbs now has four RPDDs, and this designation further increases our chances of ultimately receiving multiple PRVs. The GD2-GD3 Vaccine is an important addition to our Naxitamab program for children diagnosed with high-risk neuroblastoma. Y-mAbs continues to focus on maximizing its portfolio of rare pediatric disease assets addressing clear unmet medical needs in pediatric cancers while utilizing government programs in place for companies committed to rare pediatric cancers,” said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
Dr. Claus Moller, Chief Executive Officer further notes, “We are committed to bringing GD2-GD3 Vaccine to children with neuroblastoma, a life-threatening cancer with a clear unmet medical need. We are very pleased with the designation granted by the FDA, and plan to start a multicenter Phase II trial in neuroblastoma in 2020.”
MSK researchers developed the GD2-GD3 Vaccine and have intellectual property and other interests related to the subject of the research described in this release. MSK has institutional financial interests related to this research in the form of intellectual property rights and equity interests in Y-mAbs, the company licensing and commercializing this intellectual property.