IMA901 Granted Orphan Drug Designation by FDA

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immatics biotechnologies GmbH announced that the cancer vaccine IMA901 has been granted orphan drug designation from the FDA for the treatment of renal cell carcinoma (RCC) in HLA-A*02 positive patients. The FDA grants orphan drug designation to novel drugs aimed at treating rare diseases or conditions. In addition, it has completed patient recruitment into the pivotal phase III IMPRINT trial evaluating IMA901 for RCC.

IMA901 is a rationally designed cancer vaccine comprising 10 different tumor-associated peptides that are found to be highly overexpressed in the majority of patients suffering from RCC.

Patient Recruitment Completed

The phase III IMPRINT trial is designed to show an overall survival benefit with IMA901 in combination with sunitinib (Sutent), standard first-line therapy, in comparison to sunitinib alone in patients with metastatic and/or locally advanced RCC. The secondary endpoints include immune response to the peptides contained in IMA901, progression-free survival, safety, and tolerability.

The trial has completed patient inclusion, and it is expected that around 345 patients will be randomly assigned across 10 countries in the United States and Europe. The first (interim) overall survival results are expected during the first half of 2014.

The study aims to build on the promising survival and immune response data observed in the phase II study with IMA901 in patients with advanced RCC. These data show that patients who produced an immune response to two or more of the tumor-associated peptides contained in IMA901 had a significantly longer survival. Key data from the scientific and clinical development of IMA901 were recently published in Nature Medicine.

Chief investigator of the trial is Brian Rini, MD, of Lerner College of Medicine, Department of Solid Tumor Oncology at the Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio. The European lead investigator is Tim Eisen, MD, Clinical Director of Medical Oncology at Addenbrooke’s Hospital, University of Cambridge, UK. ■




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