TUEBINGEN, Germany, July 29, 2012 /PRNewswire/ --
Paper highlights clinical and immunological activity of IMA901 in renal cell carcinoma (RCC)
IMA901 is currently being evaluated in a pivotal phase 3 randomized study in patients with RCC
immatics biotechnologies GmbH, a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer, today announced that key data covering the scientific and clinical development of its lead cancer vaccine, IMA901, have been published in Nature Medicine. The paper highlights that renal cell carcinoma patients experience longer survival times when their immune system produces an immune response to more than one of the peptides in IMA901, the first multi-peptide therapeutic cancer vaccine for RCC.
IMA901 consists of 10 tumor-associated peptides (TUMAPs) confirmed to be naturally presented on tumor cells in patients with renal cell carcinoma (RCC). immatics identified, selected and validated the peptides in IMA901 using its proprietary XPRESIDENTTM platform, which has enabled a uniquely rational approach to cancer vaccine development.
The Nature Medicine paper reports the findings of two clinical trials with IMA901 in RCC patients. These results are the first showing that naturally presented TUMAPs are clinically relevant in the development of cancer vaccines and can produce meaningful outcomes. In contrast with a number of other cancer vaccine approaches, this research demonstrates that patients who mount a broad anti-tumor immune response experience extended survival.
In another key finding, the researchers identified two serum biomarkers which may help to determine which patients are most likely to achieve an overall survival benefit in future studies with IMA901. The current pivotal phase 3 trial with IMA901 aims to confirm that these two biomarkers are predictive of improved overall survival.
Dr Harpreet Singh, immatics' Chief Scientific Officer and corresponding author of the publication, said: "Having these results published by Nature Medicine is recognition of the rationale behind our development of IMA901 and our other pipeline products. When we formed immatics we were clear that a rational approach to cancer vaccine development was crucial for success. We have been rigorous in following a highly systematic process to identify multiple relevant peptides from primary tumor tissues and then using immunomonitoring and biomarkers to generate and advance IMA901. This journey has produced several novel findings in the cancer immunotherapy field which we believe will advance the development of cancer vaccines and could change the way the disease is managed and treated."
Paul Higham, immatics' Chief Executive Officer, said: "The potential of IMA901 to extend survival times for patients with renal cancer while offering a very good side effect profile is very exciting and offers the potential of real clinical benefit to patients with RCC. Our results so far illustrate the power of our rational approach to cancer vaccine development. We look forward to confirming the positive findings we have generated when we report the results from our on-going pivotal phase 3 trial with IMA901."
The work was performed in close collaboration with a large number of academic institutions, foremost the University of Tuebingen, where the Department of Immunology led by Prof. Hans-Georg Rammensee, also the originator of the concept behind IMA901 and co-founder of immatics and the Department of Urology led by Prof. Arnulf Stenzl, also the Principal Investigator of both clinical trials described in this publication played a vital role.
About the publication
The Nature Medicine publication summarizes the results of two clinical trials with IMA901 in a total of 96 RCC patients with a number of important clinical findings.
Firstly, these studies show that patients achieve better clinical benefit if they are able to mount immune responses to multiple peptides in the IMA901 vaccine. This confirms the hypothesis that a broad attack of the immune system on multiple targets simultaneously is beneficial.
Additionally, the study demonstrated in a randomized phase 2 trial that a single dose of cyclophosphamide given prior to the first vaccination with IMA901 reduced numbers of regulatory T cells and was associated with a better overall outcome after vaccination with IMA901. Regulatory T cells are thought to counteract the anti-tumor response of cancer vaccines.
The publication also describes the work to identify serum biomarkers to help predict which patients could achieve an overall survival benefit in future studies with IMA901. Through an analysis of over 300 potential biomarkers in pre-treatment samples from the phase 2 study with IMA901, immatics identified two biomarkers, apolipoprotein A-1 and chemokine (C-C motif) ligand 17, that could predict which patients are most likely to achieve longer survival times with IMA901. The current pivotal phase 3 trial with IMA901 aims to validate that these two biomarkers are predictive of improved overall survival.
And finally, for the first time in RCC patients, the clinical relevance of certain types of myeloid-derived suppressor cells, a novel type of regulatory cell counteracting cancer immunotherapy, was described. Sunitinib, the standard first-line therapy in RCC marketed by Pfizer, is combined in the ongoing phase 3 study with IMA901 to decrease numbers of myeloid-derived suppressor cells.
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. IMA901 has completed phase 1 and 2 development in a total of 96 RCC patients and is currently being developed in a pivotal, randomized controlled phase 3 study in combination with sunitinib.
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 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, and IMA950, which is in phase 1 in patients with glioma.
immatics' technology platform rapidly generates defined therapeutic cancer vaccines which are based on multiple tumor-associated peptides (TUMAPs) with the ability to specifically stimulate the immune system against cancer cells. These vaccines - comprising multiple peptides confirmed to be naturally presented by real tumor tissue - offer the prospect of greater effectiveness than existing therapeutic approaches combined with fewer side effects. immatics' products are 'drug like' with stable, off-the-shelf formulations and robust easily scalable manufacturing.
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
Nikola Wiegeler, Assistant to the Management
immatics biotechnologies GmbH
Citigate Dewe Rogerson
David Dible / Chris Gardner / Sita Shah
1. "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