immatics biotechnologies GmbH, a biopharmaceutical company developing rationally designed therapeutic vaccines that are active against cancer, has completed patient recruitment into the pivotal phase 3 trial evaluating its lead cancer vaccine IMA901 for renal cell carcinoma (RCC). The trial has completed patient inclusion and it is expected that around 345 patients will be randomized across 10 countries in the US and Europe. The first (interim) overall survival results are expected during the first half of 2014.

The phase 3 IMPRINT trial is designed to show an overall survival benefit with IMA901 in combination with sunitinib (Sutent, Pfizer), 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 study aims to build on the promising survival and immune response data observed in the phase 2 study with IMA901 in advanced RCC patients. These data show that patients who produced an immune response to two or more of the tumor-associated peptides (TUMAPs) 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 Professor Brian Rini, Lerner College of Medicine, Department of Solid Tumour Oncology at the Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio. The European lead investigator is Professor Tim Eisen, Clinical Director of Medical Oncology at Addenbrooke’s Hospital, University of Cambridge, UK.

Dr Carsten Reinhardt, CMO of immatics, said: “We have achieved another key milestone in immatics’ development. The rate of patient recruitment in this pivotal trial with IMA901 reflects a very high level of interest in this novel cancer vaccine for the treatment of renal cell carcinoma both by investigators and also patients. IMA901, which contains multiple highly relevant tumour peptides, has already indicated the potential to extend patient survival and we look forward to this being confirmed in this pivotal trial.”

In addition, immatics announced today that IMA901 has been granted orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of renal cell carcinoma in HLA-A 02 positive patients. The FDA grants orphan drug designation to novel drugs aimed at treating rare diseases or conditions.

Paul Higham, CEO of immatics, added: “IMA901 has been rationally designed to redirect the immune system to make it recognize and control tumours. We believe that our vaccines could deliver a step-change in the treatment of cancer patients, allowing them to live longer with their cancer while maintaining their quality of life. We are delighted with the orphan drug designation and look forward to reviewing the initial overall survival and immune response results from this phase 3 study in the first half of 2014 and the final data in 2015.”