Y-m Abs Neuroblastoma Innovative Therapy Applied for Listing

Neuroblastoma is one of the most common cancers in infants and young childrenIt is a highly invasive tumor, and even with highly potent treatments, the patient's survival rate is less than 50%Naxitamab is a humanoid monoclonal antibody that targets GD2 antigensGD2 antigens are expressed on tumor surfaces produced in the neuroblastoma layer, including neuroblastoma, melanoma and osteosarcomaBy binding to GD2 antigens on the tumor surface, Naxitamab can trigger a cytotoxic reaction of antibody vectors and activate the immune system's complement system to kill tumorsIt has been granted fda certification for the treatment of neuroblastoma and osteosarcoma, and breakthrough therapy has been identified as a combination of high-risk neuroblastomas with GM-CSFNaxitamab's mechanism of action (Photo: Y-mAbs official website)the application was submitted based on positive data from a Phase 1/2 clinical trial called 12-230In the first group of children with neuroblastoma in the trial, 28 high-risk patients who were not eligible for induced chemotherapy received a combination of naxitamab and GM-CSF, and more than half of them were also less likely to receive second-line chemotherapyTrial data show that the therapy achieved a 78 percent objective remission rate (ORR) for patients and 50 percent of patients without progression (PFS) to 24 monthsIn the second group of patients, 30 patients who received salvage therapy but did not perform well received a combination of naxitamab and GM-CSF, one-third of whom had relapsed more than twice, and 89 percent had been treated with anti-GD2 drugsTrial data show that the treatment caused patients to reach 37% ORR and 36% of patients with PFS to 24 monthsNaxitamab brings PFS to 24 months in 50 percent of neuroblastoma patients (Photo: Source: 3)"We are pleased to be able to launch naxitamab's rolling BLA, which is an important milestone for Y-mab," said Thomas Gad, founder, president and head of business development and strategy at Y-mAbReferences:1 sY-mAbs Initiates Submissions Submissions of Biologics License Application to U.S FDA for Naxitamab for Treatment of Neuroblastoma, Retrieved 2, 2019 from from http://ir.ymabs.com/news-releases/news-release-details/y-mabs-initiates-rolling-submission-biologics-license , Y-mAbs Files Leader neuroblastoma in US, Retrieved December 2, 2019, from https:// 3, Y-mAbs Company Presentation, Retrieved December 2, 2019, from ir.ymabs.com/static-files/79670dc5-8cb9-4982-a93d-31fd4577db48 original title: Courier - For the benefit of children with refractory brain tumors, innovative therapies have been submitted for rolling listing applications