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 Multi Peptide 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.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 XPRESIDENT [ TM ]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. For additional information on immatics please visit http://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: email@example.com Citigate Dewe Rogerson David Dible / Chris Gardner / Sita Shah Phone: +44-207-638-9571 E-mail: firstname.lastname@example.org SOURCE immatics