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Apeiron Signs Regional License Agreements for the Commercialization of its Neuroblastoma Therapy

Austrian biotech company APEIRON Biologics AG (“Apeiron”) announced  today that a phase I clinical trial with its neuroblastoma immunotherapy APN311 has received all necessary approvals to start recruiting patients. The trial will be locally conducted by Nagoya University Hospital and is part of a long-term collaboration to make this therapy available to patients suffering from this severe type of children’s cancer. In Japan, it won a grant by the Japanese government as an Investigator-initiated clinical trial that utilizes collaboration between the Department of Pediatrics and the Center for Advanced Medicine and Clinical Research (CAMCR) at Nagoya University Hospital.

“This is a great achievement for us as we have supported this joint effort from the very beginning. Two years ago the ground was prepared when the Austrian Embassy – Commercial Section in Tokyo hosted a scientific meeting for Japanese pediatric oncologists to learn about this innovative therapy of pediatric neuroblastoma developed by Apeiron ”, says Dr. Martin Glatz, Commercial Counsellor of the Austrian Embassy. “The meeting two years ago was part of a focus program aiming to bring more Austrian medical research and biotech companies to the Japanese market. The market has seen tremendous changes recently with companies exploring new opportunities and the government addressing regulatory issues,” he added. Hans Loibner, PhD, CEO of Apeiron, commented, "We are very happy and proud to be rewarded with this milestone achievement after all the effort that was invested. I would like to particularly thank the physicians from Nagoya University, Dr. Seiji Kojima and Dr. Yoshiyuki Takahashi, as well as Dr. Masaaki Mizuno, Dr. Katsuyoshi Kato and Dr. Shinobu Shimizu at CAMCR, as we owe it to their dedication and tireless work that this trial can now start. We are confident that Japanese patients will benefit from the introduction of APN311 to Japan and look forward to making the next steps towards approval of this promising antibody therapy of neuroblastoma by the Japanese regulatory authorities.” About Neuroblastoma and APN311 Neuroblastoma is the most common extracranial solid cancer in infants and children with 50% of all cases being diagnosed within the first year after birth. APN311 is a monoclonal chimeric antibody (ch14.18/CHO) targeting the GD2 antigen on neuroblastoma cells and is currently in preparation for submission for marketing authorization both in US and Europe.

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