Apeiron licences neuroblastoma antibody

Six months ago, it was not clear if Apeiron biologics would market its neuroblastoma treatment dinutuximab beta on its own or through a partnership, according to CEO Hans Loibner. Now, the small Austrian company has decided how it will compete against the large US company United Therapeutics, which got FDA approval for a similar antibody last year. British EUSA Pharma has acquired the exclusive global commercialisation rights for the cancer immunotherapy that targets glycolipid GD2, expressed on neuroblastoma cells and on normal cells. Dinutuximab beta, which Apeiron has filed for EU approval, is currently used as part of the regimen for the treatment of high risk neuroblastoma in Europe and is available under a managed access programme. The immunotherapy has orphan drug designation in the US and EU. EUSA expects to file the product for registration in the US and Japan in 2017.

Financial details on the upfront payment and milestones or royalites were not disclosed. In the United States, the company plans to submit a regulatory filing in 2017, and once approved, will commercialise the product directly through its established US infrastructure. In other territories, including Japan, EUSA plans to bring the product to market through its international network of partners.

While United Therapeutics’ Unituxin is given in combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), to children with neuroblastoma, Apeiron’s antibody Isquette, which had been licenced from Scripps Research Institute in 2011, seems also effective without administration of IL-2, which induces inflammatory side effects such as capillary leak syndrome.