Naxitamab

Y-mAbs Announces Publication in Cancers

Retrieved on: 
Monday, October 16, 2023

“The publication in Cancers further validates the utilization of naxitamab early during the course of treatment for patients with high-risk neuroblastoma,” said Thomas Gad, Founder, President and Interim Chief Executive Officer.

Key Points: 
  • “The publication in Cancers further validates the utilization of naxitamab early during the course of treatment for patients with high-risk neuroblastoma,” said Thomas Gad, Founder, President and Interim Chief Executive Officer.
  • Cycles were administered 3-5 weeks apart and the primary endpoint was overall response rate (CR + partial response (“PR”)).
  • The HITS combination did not appear to exacerbate the rate nor the intensity of infusion-related toxicities of naxitamab when observed as a stand-alone treatment.
  • Researchers at Memorial Sloan Kettering Cancer Center (MSK) developed DANYELZA® (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs.

Y-mAbs Reports Second Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, August 10, 2023

On May 23, 2023, Y-mAbs announced that the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“ANVISA”) granted marketing authorization for DANYELZA (naxitamab-gqgk).

Key Points: 
  • On May 23, 2023, Y-mAbs announced that the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“ANVISA”) granted marketing authorization for DANYELZA (naxitamab-gqgk).
  • The DANYELZA net product revenues for the quarter ended June 30, 2023 represents an increase of 3% compared to the first quarter of 2023.
  • As of June 30, 2023, Y-mAbs has delivered DANYELZA to 56 centers across the U.S., a sequential increase of 6% in the number of centers since the first quarter of 2023.
  • During the second quarter of 2023, approximately 61% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSKCC”), which is in line with the first quarter of 2023.

Y-mAbs Announces Presentation of Naxitamab Data at ASCO

Retrieved on: 
Friday, May 26, 2023

The ongoing Phase 2 Trial 201 (NCT03363373) evaluates naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in patients with relapsed or refractory HR-NB with residual disease limited to bone and/or bone marrow.

Key Points: 
  • The ongoing Phase 2 Trial 201 (NCT03363373) evaluates naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in patients with relapsed or refractory HR-NB with residual disease limited to bone and/or bone marrow.
  • Curie Score (“CS”) is a semi-quantitative scoring system used to assess the extent of bone metastases and treatment response.
  • An interim analysis of Trial 201 (data cutoff December 31, 2021) included 52 patients in the efficacy group and 74 patients in the safety group.
  • Patients with refractory disease had a lower frequency of serious naxitamab related adverse events compared to patients with relapsed disease.

Y-mAbs Announces Presentation of Naxitamab data at AACR

Retrieved on: 
Tuesday, April 18, 2023

The disialoganglioside GD2 has been shown to be upregulated in triple-negative breast cancer (“TNBC”) and its high expression is associated with a poor prognosis.

Key Points: 
  • The disialoganglioside GD2 has been shown to be upregulated in triple-negative breast cancer (“TNBC”) and its high expression is associated with a poor prognosis.
  • Y-mAbs provided naxitamab (DANYELZA) to this pre-clinical investigator sponsored study (“ISS”) at M.D.
  • 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.

Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab

Retrieved on: 
Thursday, February 2, 2023

The decision follows a positive opinion from EMA’s Pediatric Committee (“PDCO”).

Key Points: 
  • The decision follows a positive opinion from EMA’s Pediatric Committee (“PDCO”).
  • Naxitamab is being developed by Y-mAbs for the treatment of patients with relapsed/refractory high-risk neuroblastoma, which is the indication targeted by the PIP, as well as osteosarcoma.
  • An approved PIP is a prerequisite for filing a Marketing Authorization Application (“MAA”) for any new medicinal product in Europe.
  • Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs.

Y-mAbs Announces Naxitamab Chemoimmunotherapy Investigational Trial for High-Risk Neuroblastoma Meets Primary Endpoint

Retrieved on: 
Thursday, May 26, 2022

Health authorities have not established the safety and efficacy of the HITS protocol, as it is investigational and has not been approved by health authorities.

Key Points: 
  • Health authorities have not established the safety and efficacy of the HITS protocol, as it is investigational and has not been approved by health authorities.
  • The primary endpoint of the phase 2 trial at MSK was complete response (CR) and partial response (PR) after 4 cycles.
  • The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate (ORR) according to the International Neuroblastoma Response Criteria (INRC) of 30.6 %, with a lower boundary of 20.4%.
  • In the MSK phase 2 trial, the ORR was 64% for all patients, with soft tissue (48%) and skeletal MIBG uptake (66%).

UPDATE - Y-mAbs Announces Pipeline Update

Retrieved on: 
Wednesday, December 15, 2021

The Y-mAbs research and development day will feature presentations from oncology key opinion leaders (KOLs) Javier E. Oesterheld, M.D.

Key Points: 
  • The Y-mAbs research and development day will feature presentations from oncology key opinion leaders (KOLs) Javier E. Oesterheld, M.D.
  • An update on Y-mAbs broad and advanced product pipeline, including the Companys SADA Technology, will follow from Vignesh Rajah, MBBS, DCH, MRCP(UK), MBA, (SVP, Chief Medical Officer at Y-mAbs) and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).
  • Dr. Lisby will present new details on the proposed mechanism of action for the SADA Technology.
  • The Company plans to file an Investigational New Drug Application (IND) with the US Food & Drug Administration (FDA) for GD2-SADA by the end of this year.

Y-mAbs Announces Pipeline Update

Retrieved on: 
Wednesday, December 15, 2021

The Y-mAbs research and development day will feature presentations from oncology key opinion leaders (KOLs) Javier E. Oesterheld, M.D.

Key Points: 
  • The Y-mAbs research and development day will feature presentations from oncology key opinion leaders (KOLs) Javier E. Oesterheld, M.D.
  • An update on Y-mAbs broad and advanced product pipeline, including the Companys SADA Technology, will follow from Vignesh Rajah, MBBS, DCH, MRCP(UK), MBA, (SVP, Chief Medical Officer at Y-mAbs) and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).
  • Dr. Lisby will present new details on the proposed mechanism of action for the SADA Technology.
  • Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.