Clinical Trials

Date: 2017-12-18

Type of information: Publication of results in a medical journal

phase:

Announcement: publication of results in mAbs

Company: Apeiron Biologics (Austria)

Product: Qarziba®/Isqette® (APN311 - dinutuximab beta)

Action mechanism:

• monoclonal antibody. Isqette® is a monoclonal antibody that has been designed to recognise and attach to GD2 antigen. This antigen is present in high amounts on the surface of neuroblastoma cells, but not normal cells. When the medicine attaches to the neuroblastoma cells, it marks them out as a target for the body’s immune system, which is then expected to attack the cancer cells and thereby reverse or slow down the progression of the disease.
• Dinutuximab beta has been generated and profiled by European academic institutions originating at the Clinical Cancer Research Institute in Vienna (St. Anna Children's Hospital), initiated by Prof. Ladenstein. The development was extended to multiple clinical trials across Europe and abroad, performed by the SIOPEN neuroblastoma study group and the German group at the University Children's Hospital Greifswald led by Prof. Lode.
• Apeiron Biologics has granted EUSA Pharma, exclusive global commercialization rights to Isqette® (APN311, dinutuximab beta) in October 2016.

 

Disease: neuroblastoma

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• • On December 18, 2017, Apeiron Biologics announced the publication of a successful clinical study in high-risk neuroblastoma patients in the December issue of mAbs (“Tolerability, response and outcome of high-risk neuroblastoma patients treated with long-term infusion of anti-GD2 antibody ch14.18/CHO”). Dr. Holger Lode, Professor and Chair of the Department of General Pediatrics and Pediatric Hematology and Oncology of the Faculty of Medicine of the University of Greifswald, Germany, conducted the study as primary investigator, in collaboration with Apeiron Biologics. Treatment with antibodies, directed against disialoganglioside GD2, has emerged as an important therapeutic option for patients with neuroblastoma. The study successfully explored a GD2 antibody administration schedule of 10 day continuous slow infusion, to limit treatment-associated neuropathic pain, while preserving efficacy. To date, neuropathic pain has been an obstacle to the wider adoption of GD2 antibodies.
• The study results were a key component of Apeiron’s Marketing Authorisation Application for the anti-GD2 antibody dinutuximab beta to the European Medicines Agency, which was granted in May, 2017. These data will also form a key part of the upcoming Biologics Licence Application (BLA) to the FDA in the U.S. which is expected during 2018. The published paper evaluates the toxicity, clinical response and survival of anti-GD2 antibody ch.14.18/CHO (dinutuximab beta). The data demonstrate that dinutuximab beta (together with IL-2) given by long-term infusion is associated with a substantially reduced pain and thus could be delivered in an outpatient setting. The single-center study, without a control group, showed a best response rate of 40% and a significantly prolonged survival compared to matched historical controls.

Is general: Yes