Mouse-human chimeric mAb targeting GD2 was developed by CCRI and SIOPEN.

Apeiron Biologics has taken over rights to further develop, file for regulatory approval, and market the antibody ch14.18, which was developed as an immunotherapy for high-risk neuroblastoma by the Children’s Cancer Research Institute (CCRI) and the European Neuroblastoma Research Network (SIOPEN). It is currently in a Phase III trial across various European clinical centers.

Ch14.18 is a mouse-human chimeric mAb against the antigen GD2 (a disialoganglioside), which is strongly expressed on the surface of neuroblastoma cells. It is currently in a number of Phase III studies in Europe, with one evaluating whether the concomitant subcutaneous administration of interleukin-2 improves the efficacy of ch14.18.

As part of the agreement, Apeiron will provide substantial support for an ongoing European Phase III trial. Due to the limited number of clinical centers specializing in the treatment of high-risk neuroblastoma, Apeiron is considering marketing the therapy on its own.

Austrian company Polymun Scientific has been producing clinical supplies for the CCRI/SIOPEN-sponsored clinical studies. Apeiron has now commissioned Polymun to continue production and to prepare for commercial supply of the material.

The conclusion of its arrangement with CCRI and SIOPEN marks the second milestone for Apeiron’s strategy to treat neuroblastoma. Earlier this year the firm licensed Phase II-stage neuroblastoma candidate Hu14.18-IL2 from Merck KGaA.

Hu14.18-IL2 comprises the hu14.18 mAb linked to interleukin 2. The fusion protein is designed to bind to the GD2 antigen. It is expected both to stimulate immune system NK and T-cell activity against the tumor and trigger tumor cell killing by antibody-dependent cellular cytotoicity and complement-dependent cytotoxicity mechanisms.

Apeiron has two more projects in its clinical pipeline. APN201 is a liposomal formulation of recombinant human superoxide dismutase in Phase II for the prevention or treatment of skin damage due to radiation treatment in cancer.

APN01, a recombinant human angiotensin converting enzyme 2, was licensed to GlaxoSmithKline last year for £11 million up front. It is expected to commence a Phase II study in acute respiratory distress syndrome in the near future.

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