APEIRON Biologics AG grants EUSA Pharma, UK exclusive global commercialization rights to the oncology product ISQETTE. ISQETTE is an antibody-based immunotherapy with orphan drug designation for the treatment of pediatric neuroblastoma. The therapy has been developed by APEIRON together with an academic network including the St. Anna Children's Cancer Research Institute in Vienna.
APEIRON Biologics AG, a private biotech company based in Vienna, Austria, developing immunological therapies against cancer, today announced that it grants EUSA Pharma, UK exclusive global commercialization rights to the immuno- oncology product ISQETTE (APN311, dinutuximab beta). In Europe, dinutuximab beta is widely used in clinical trials as part of the regimen for the treatment of high risk neuroblastoma with approx. 1,000 patients treated and is available under a managed access program. The immunotherapy has orphan drug designation in the US and EU and is currently under review for marketing approval by the European Medicines Agency (EMA). Under the terms of the agreement, APEIRON receives an upfront fee, regulatory milestone payments upon marketing approval in key territories and royalties on future product sales.
Dr. Hans Loibner, APEIRON Biologics' Chief Executive Officer comments "The global license for commercialization of our most advanced project APN311 is a major step forward in the successful development of the company. It validates our strength in advanced clinical development of cancer immunotherapies. ISQETTE may get European marketing approval soon and deserves a competent partner for future commercialization. With its strong focus on oncology and specialty commercial expertise in Europe, the US and further afield, EUSA Pharma is an excellent partner to bring ISQETTE to the market."
"We are delighted to acquire the global rights to ISQETTE[R], which is a perfect fit with our strategic focus in the specialty oncology field and will allow us to leverage our commercial infrastructure in the EU and expand our presence in the US. We look forward to working with the experienced APEIRON team", adds Lee Morley, EUSA Pharma's Chief Executive Officer.
ISQETTE is a monoclonal antibody that specifically targets the GD2 antigen expressed on the surface of neuroblastoma cells and thereby initiates a selective immunological attack against these tumor cells. Clinically relevant activity has been widely observed upon treatment, also in advanced stages of the...