immatics initiates IMA901 Phase III trial in renal cell carcinoma

igoommatics biotechnologies GmbH, a biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer, announced today that the first patients have been vaccinated in the IMPRINT study, a pivotal Phase III trial with IMA901, the company's lead cancer vaccine for the treatment of renal cell carcinoma (RCC).

The trial is designed to demonstrate the overall survival benefit of IMA901 in combination with standard first-line therapy in RCC patients. The study builds on the promising survival and immune response data observed in the Phase II study with IMA901 in advanced RCC patients. Data from the Phase II study were presented at ASCO in June 2010 and at ESMO in October 2010.

IMPRINT is a global multicenter, randomized, controlled Phase III study in patients with metastatic and/or locally advanced RCC who are candidates for receiving standard first-line therapy with sunitinib (Sutent®,Pfizer). The trial will include approximately 330 patients across the US and Europe.

The primary endpoint of the Phase III study is overall survival in patients receiving IMA901 in combination with sunitinib versus sunitinib alone. Overall survival will also be tested in patients who are positive for a prospectively defined biomarker signature. This signature was identified as being predictive for improved clinical outcome in IMA901-vaccinated patients in the previous Phase II study. Details on the biomarker signature were presented in the plenary session of the Annual Meeting of Association for Cancer Immunotherapy (CIMT) in late May 2011.

Further secondary endpoints include progression-free survival, safety and tolerability, and cellular immunomonitoring to assess the T-cell response to the peptides contained in IMA901. Data from the reported Phase II trial showed that the intensity of the immune response against the IMA901 TUMAPS vaccine was predictive for improved overall survival.

The first overall survival results of the study are expected in late 2013. The chief investigator of the trial is Professor Brian Rini, Associate Director for Clinical Research at the Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio and Professor Tim Eisen, Clinical Director of Medical Oncology at Addenbrooke´s Hospital, University of Cambridge, UK, is the European lead investigator.

Carsten Reinhardt, CMO of immatics, said: "The start of this Phase III trial with IMA901 is a key milestone in immatics' clinical development. The protocol for this trial builds on the encouraging insights gained from the Phase II study and feedback from key opinion leaders as well as successful meetings with regulatory agencies both in Europe and the US. We look forward to confirming the positive overall survival data seen in the phase II study as advanced renal cell cancer still has a very high unmet medical need."

Paul Higham, CEO of immatics, added: "An overall survival benefit combined with a stable and easy to manufacture formulation would make IMA901 an important breakthrough in the development of therapeutic cancer vaccines."