Y-mAbs Announces Recruitment Status for Pivotal Trials
Y-mAbs Therapeutics, Inc. recently announced the status of patient recruitment for the company’s two pivotal Phase 2 trials, one for omburtamab for the treatment of CNS/LM from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma.
As of the end of June 2019, all of the 18 planned omburtamab patients have been enrolled. The company expects the study to remain open and continue enrolling patients until the product potentially becomes available on the market and believes it remains on target to file a biologic license application (BLA) by the end of 2019 under the breakthrough therapy designation (BTD) the company previously received from the FDA. The company has also previously received orphan drug designation (ODD) and a rare pediatric disease designation (RPDD) for omburtamab from the FDA, in each case for the treatment of CNS/LM from neuroblastoma. The RPDD qualifies the company for receipt of a priority review voucher (PRV) upon approval of omburtamab for the treatment of CNS/LM from neuroblastoma, if such approval occurs.
For naxitamab, more than 30 patients of a planned total of 37 patients in the company’s Study 201 have been enrolled as of the end of June 2019. The company expects the remaining patients to be included in the coming weeks and believes it remains on target for a BLA filing in 2019 under the BTD the company previously received from the FDA for naxitamab in combination with GM-CSF for the treatment of relapsed/refractory high-risk neuroblastoma. The company has also previously received ODD and a RPDD from the FDA for naxitamab, in each case for the treatment of relapsed/refractory high-risk neuroblastoma. The RPDD qualifies the company for receipt of a PRV upon approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma, if such approval occurs.
“We are approaching an important milestone by reaching our initial patient recruitment goals for both compounds and focus on advancing these treatments to give children access,” said Thomas Gad, Founder, Chairman, President, and Head of Business Development and Strategy.
Dr. Claus Moller, Chief Executive Officer, added “We believe the two important BLA filings are on track in line with our timelines and previous guidance. We salute and thank health authorities, clinical sites and our staff for their combined efforts in moving these compounds forward towards registration. We hope to see both of these new and important cancer treatments on the market in 2020. We believe these new product candidates have the potential to become historic milestones for pediatric oncology.”
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.
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