On October 16, 2020 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 therapeutic products for the treatment of cancer, reported clinical updates on naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma and omburtamab for CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 16, 2020, View Source [SID1234568579]). Data was presented at the International Society of Pediatric Oncology ("SIOP") Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. The naxitamab data was presented by Dr. Jaume Mora from SJD Barcelona Children’s Hospital, and the omburtamab data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center ("MSK").

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Naxitamab
In a poster presentation, Dr. Mora presented data from the Company’s pivotal 201 multicenter study. The central independent evaluation showed an overall rate of response ("ORR") of 68% and the rate of complete response ("CR") was 59% for the 22 patients. In addition, bone marrow clearance was observed with complete response in 7 of 9 patients, who had positive bone marrow at trial start. The median duration of response with long-term follow-up was 27 weeks.

"We are excited to share this new clinical data for naxitamab, which we believe could be a very important new treatment for high-risk neuroblastoma patients, if approved. Naxitamab is administered in an outpatient setting, and the FDA previously set a PDUFA date of November 30, 2020," said Thomas Gad, founder, Chairman and President.

Omburtamab
In an oral presentation, Dr. Kramer presented planned interim results for 17 patients enrolled on the Company’s pivotal 101 multicenter study. The study showed a twelve-months overall survival ("OS") of 87%, with a median follow-up of 26 weeks. This compares to an OS of approximately 30% in a historic control group previously disclosed by the Company.

"The preliminary OS results from the multicenter Study 101 are encouraging and appears almost identical to the results of Study 03-133, which was conducted at MSK. While recruitment is still ongoing, we are very pleased to see the preliminary omburtamab data in the multicenter setting appearing supportive of the conclusions from the MSK data. We believe the preliminary survival curves are very similar to the original MSK data, and this is good news for children with CNS/leptomeningeal metastasis from neuroblastoma," said Claus Moller, Chief Executive Officer.

Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs.