Dinutuximab

APEIRON shareholders approve new group structure geared towards enabling innovation and growth

Retrieved on: 
Tuesday, April 26, 2022

Shareholders in APEIRON Biologics AG will be granted shares in invIOs Holding AG pro rata to their current shareholdings in APEIRON Biologics AG.

Key Points: 
  • Shareholders in APEIRON Biologics AG will be granted shares in invIOs Holding AG pro rata to their current shareholdings in APEIRON Biologics AG.
  • AResT will drive the development of APN01, currently being developed for the treatment of COVID-19 and other respiratory and pulmonary indications.
  • The new group structure approved by the AGM is an important step forward in enabling our innovation and growth, and we are grateful to our shareholders for their ongoing support.
  • APEIRON Biologics is a privately held biotech company based in Vienna, Austria.

invIOs goes live with unique cell therapy platform and clinical-stage immuno-oncology pipeline

Retrieved on: 
Thursday, December 16, 2021

The proprietary cell therapy technology platform for the modulation of intracellular Immuno-Oncology targets enables rapid treatment of patients using their own cells with short out-of-body time in an out-patient setting.

Key Points: 
  • The proprietary cell therapy technology platform for the modulation of intracellular Immuno-Oncology targets enables rapid treatment of patients using their own cells with short out-of-body time in an out-patient setting.
  • The groundbreaking concept allows access to indications that have previously not been addressable by earlier cell therapy approaches.
  • The novel concept allows access to and treatment for indications that had not previously been addressable by cell therapy.
  • The second candidate of the platform is INV441, an early-stage cell therapy approach aiming to activate tumor-associated immune cells.

EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for QARZIBA®▼ (Dinutuximab Beta) in China

Retrieved on: 
Monday, November 9, 2020

EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for QARZIBA (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review.

Key Points: 
  • EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for QARZIBA (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review.
  • Dinutuximab beta is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.
  • For paediatric patients fighting this disease in China, we are hopeful that dinutuximab beta will soon be available as a new treatment option.
  • We look forward to working with BeiGene and the NMPA to potentially make dinutuximab beta available in China.

Y-mAbs Announces Data to be Presented at 2020 SIOP

Retrieved on: 
Monday, July 27, 2020

Food and Drug Administration(FDA) for the treatment of patients with relapsed/refractory high-risk neuroblastoma.

Key Points: 
  • Food and Drug Administration(FDA) for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
  • The FDA set an action date ofNovember 30, 2020, under the Prescription Drug User Fee Act (PDUFA).
  • The Company has a broad and advanced product pipeline, including two pivotal-stage product candidates naxitamab and omburtamabwhich target tumors that express GD2 and B7-H3, respectively.
  • Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges.

Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA

Retrieved on: 
Wednesday, April 1, 2020

The naxitamab BLA is for the treatment of patients with relapsed/refractory high-risk neuroblastoma.

Key Points: 
  • The naxitamab BLA is for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
  • As the father of a long-term high-risk neuroblastoma survivor, I am excited to see Y-mAbs first BLA submission in neuroblastoma completed.
  • Dr. Claus Moller, Chief Executive Officer, continued, With this submission, we look forward to working with the Agency to bring naxitamab to appropriate patients.
  • We are excited to complete this submission and believe naxitamab can address a significant unmet medical need for children with relapsed/refractory high-risk neuroblastoma.

EUSA Pharma and BeiGene Announce Exclusive Development and Commercialization Agreement for SYLVANT® and QARZIBA®▼ in Greater China

Retrieved on: 
Monday, January 13, 2020

and BEIJING, China, Jan. 13, 2020 (GLOBE NEWSWIRE) -- EUSA Pharma (EUSA) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT (siltuximab) and QARZIBA (dinutuximab beta) in Greater China.

Key Points: 
  • and BEIJING, China, Jan. 13, 2020 (GLOBE NEWSWIRE) -- EUSA Pharma (EUSA) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT (siltuximab) and QARZIBA (dinutuximab beta) in Greater China.
  • Under the terms of the agreement, EUSA has granted BeiGene exclusive rights to SYLVANT in Greater China and to QARZIBAin mainland China.
  • Under the agreement, BeiGene will fund and undertake all clinical development and regulatory submissions in the territories, and will launch and commercialize both products once approved.
  • BeiGene brings to our collaboration exceptional development and commercialization capabilities in China and a clear focus on delivering innovative, targeted oncology medicines.

Global Neuroblastoma Drugs Market 2019-2023 | Evolving Opportunities with Bristol-Myers Squibb and Johnson & Johnson | Technavio

Retrieved on: 
Tuesday, January 7, 2020
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20200107005706/en/
    Technavio has announced its latest market research report titled global neuroblastoma drugs market 2019-2023.
  • In addition, increasing R&D for treatment of relapsed refractory neuroblastoma are anticipated to positively impact the growth of the neuroblastoma drugs market.
  • The primary reason for the boost in sales of neuroblastoma drugs such as anti-GD2 is their ability to provide site-specific action.
  • Therefore, physicians are prescribing anti-GD2 monoclonal antibodies as the neuroblastoma drugs for the treatment of neuroblastoma.

Y-mAbs Announces Positive Naxitamab Frontline Data 

Retrieved on: 
Wednesday, December 11, 2019

Dr. Mora, who has experience treating frontline neuroblastoma patients with both naxitamab and a competing anti-GD2 antibody, will present clinical data from both antibodies.

Key Points: 
  • Dr. Mora, who has experience treating frontline neuroblastoma patients with both naxitamab and a competing anti-GD2 antibody, will present clinical data from both antibodies.
  • The naxitamab treatment was well-tolerated, and the infusion related pain generally associated with anti-GD2 antibodies required significantly less opioids for naxitamab than for the competing anti-GD2 antibody.
  • A second frontline study with naxitamab is currently ongoing at MSK in New York City, and Y-mAbs expects data from this study to be published in the first half of 2020.
  • Dr. Claus Moller, Chief Executive Officer further notes, We are excited to share the first ever frontline data from naxitamab, and believe this to be class leading clinical results.

EUSA Pharma Announces New QARZIBA®▼ (Dinutuximab beta) Data to Be Presented at 2019 ASCO Annual Meeting

Retrieved on: 
Wednesday, May 29, 2019

Lee Morley, EUSA Pharma's Chief Executive Officer, said, "We are delighted these new data supporting the efficacy and tolerability of QARZIBA (dinutuximab beta) in both the maintenance phase of first-line treatment of high-risk neuroblastoma as well as relapsed/refractory neuroblastoma will be presented at the prestigious ASCO Annual Meeting.

Key Points: 
  • Lee Morley, EUSA Pharma's Chief Executive Officer, said, "We are delighted these new data supporting the efficacy and tolerability of QARZIBA (dinutuximab beta) in both the maintenance phase of first-line treatment of high-risk neuroblastoma as well as relapsed/refractory neuroblastoma will be presented at the prestigious ASCO Annual Meeting.
  • The presentations by Professor Ladenstein and Professor Lode will be held in the Paediatric Oncology Oral Abstract Session on Sunday, June 2, 8:00-11:00am.
  • Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.
  • Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease.