Date: 2011-06-22
Type of information: Clinical research agreement
Compound: antibody ch14.18
Company: Apeiron Biologics (Austria) - Children’s Cancer Research Institute (CCRI) - European Neuroblastoma Research Network (SIOPEN)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
licensing
Action mechanism: Ch14.18 is a mouse-human chimeric monoclonal antibody against the antigen GD2 (a disialoganglioside) that is strongly expressed on the surface of neuroblastoma cells. The antibody is produced in Chinese Hamster Ovary cells and purified from the supernatant. The anti-tumor effect of ch14.18 is first and foremost based on the triggering of the body’s own immunological mechanisms to destroy tumor cells to which the antibody binds due to its specificity for GD2. Ch14.18 has already shown clinical efficacy in form of remissions in children with high-risk neuroblastoma in a phase I study conducted by SIOPEN. It is currently being tested in a broad multicentric phase III trial and other studies in many European countries. This phase III study also evaluates whether the concomitant subcutaneous administration of interleukin-2 improves the efficacy of ch14.18. Interleukin-2 is a commercially available protein that activates the body’s immune cells
Disease: neuroblastoma
Details: Apeiron Biologics AG has announced an agreement with the Children’s Cancer Research Institute (CCRI) and the European Neuroblastoma Research Network (SIOPEN). Thereby, Apeiron obtains the rights to further develop, file for regulatory approval and market the antibody ch14.18. This monoclonal antibody exhibits therapeutic effect against highrisk neuroblastoma, an aggressive form of infant cancer. As part of the agreement, Apeiron will provide substantial support for an ongoing European clinical phase III trial with ch14.18. Due to the limited number of clinical centers specializing in the treatment of high-risk neuroblastoma, Apeiron isconsidering marketing the therapy on its own.
The Austrian company Polymun Scientific, a long-time business partner of Apeiron, has already been producing clinical supplies for the CCRI/SIOPEN sponsored clinical studies. Apeiron has now commissioned Polymun to continue production and to prepare for manufacture of material at market standard.
Financial terms: Financial details were not disclosed.
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