Microsoft word - 12_imm_06_immatics' ima901 completes phase 3 patient recruitment and is granted us orphan drug designation.doc

PRESS RELEASE -/ ACTIVE AGAINST CANCER immatics’ renal cancer vaccine IMA901 completes phase 3 patient recruitment and is granted US orphan drug designation by the FDA Tuebingen, 08. November 2012 - immatics biotechnologies GmbH, a biopharmaceutical company developing rationally designed therapeutic vaccines that are active against cancer, announced today that it 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 Tumor 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 tumor peptides, has already indicated the potential to extend patient survival and we look forward to this being confirmed in this pivotal trial.” US orphan drug designation for IMA901 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 tumors. 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.” * IMPRINT = IMA901 MultiPeptide vaccine Randomized INTernational study ** “Multipeptide immune response to cancer vaccine IMA901 after single-dose cyclophosphamide associates with longer patient survival,” Walter S., Weinschenk T. et al. (2012) Nature Medicine. Published online: 29. July 2012. For additional information on immatics please visit www.immatics.com or contact: Paul Higham, CEO Dr. Nikola Wiegeler, Assistant to the Management immatics biotechnologies GmbH Phone: +49 7071 5397 110 E-mail: media@immatics.com Citigate Dewe Rogerson David Dible / Chris Gardner / Sita Shah Phone: +44 207 638 9571 E-mail: david.dible@citigatedr.co.uk About IMA901 IMA901 is a rationally designed cancer vaccine comprising 10 different tumor-associated peptides (TUMAPs) that are found to be highly over-expressed in the majority of patients suffering from RCC. IMA901 is a peptide-based vaccine with a stable, off-the-shelf formulation and robust and easily scalable manufacturing. About immatics immatics biotechnologies is a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer. immatics’ lead product, IMA901, is in a pivotal phase 3 study after completing a successful randomized phase 2 trial in renal cell carcinoma. immatics’ pipeline also includes IMA910, which has reported improved overall survival data in patients with advanced colorectal cancer (phase 1/2 study completed), and IMA950, which is in phase 1 in patients with glioma. immatics’ unique technology platform XPRESIDENTTM discovers novel relevant cancer antigens known to be expressed on tumor cells, tumor-associated peptides (TUMAPs), as the basis for its vaccines. In contrast to widely used existing in silico and indirect methods to identify peptide antigens immatics’ TUMAPs are confirmed to be naturally expressed in primary cancer tissue. TUMAPs activate white blood cells (so called cytotoxic T cells) against tumor cells. immatics’ vaccines contain multiple TUMAPs to maximize the chances of clinical success by increasing the number of targets on cancer cells that they address. Phase 2 results with IMA901 and IMA910 have shown significantly better survival in patients who respond to multiple TUMAPs in both of these vaccines. immatics’ multi-peptide vaccines are ‘drug like’, i.e. fully synthetic, off-the-shelf, easily scalable and stable. immatics is based in Tuebingen and Martinsried (Munich), Germany.

Source: http://www.bioregio-stern.de/files/attachments/news/12_imm_06_immatics_ima901_completes_phase_3_patient_recruitment_and_is_granted_us_orphan_drug_designation.pdf