Multicenter clinical study authorized in France, with principal investigators Pr Luc Thomas and Pr Stephane Dalle, Hospices Civils de Lyon; patient enrollment expected to start in January 2015.
GRENOBLE, France, Dec. 10, 2014 /PRNewswire/ — ImmunID, an immune molecular diagnostics company, announced today that the ethic committee and regulatory bodies have granted authorizations to start its PREDICT-ID Melanoma study to assess the predictive value of immune profiles for response to Ipilimumab®, an immunomodulatory agent approved in more than 40 countries.
ImmunID's strategic goal is to set the global immune Molecular Diagnostic (iMDx) standard. As part of its strategy, ImmunID is focusing on cancers and particularly on metastatic melanoma, a cancer with high unmet needs. After decades of disappointing results with chemotherapy or targeted therapy, recent clinical successes observed with immunotherapy in melanoma (Ipilimumab, an anti-CTLA-4 antibody, Nivolumab and Pembrolizumab, two anti-PD-1 antibodies, as well as other immune checkpoint inhibitors) confirm the relevance of using the body's own immune system against the tumor. Unfortunately, only a small subset of patients achieves benefit from these immunotherapies, which, at the same time, can cause serious adverse events. So far no marker predicting response or toxicity has been found for these therapies, which expose a high proportion of patients to unnecessary safety risk, potentially without benefit.
Having already successfully showed in a retrospective case study that it is possible to stratify non-responders to Ipilimumab using the ImmunTraCkeR® test (results presented by Dr. Michael Postow from the Memorial Sloan Kettering Cancer Center at the Society for ImmunoTherapy of Cancer Annual Meeting on November 8th, 2014), ImmunID decided to initiate a nationwide French multicenter study for the use of immune competence profiles evaluated by ImmunTraCkeR® as a predictive biomarker of response to Ipilimumab in metastatic melanoma.
The PREDICT-ID Melanoma study was just authorized by French regulatory bodies. The clinical trial will start in January 2015 in more than eight centers and will enroll 200 patients treated with Ipilimumab, according to the current clinical practices. ImmunTraCkeR® testing will be performed before the start of Ipilimumab dosing and regularly during the course of treatment, up to the clinical response assessment.
Professor Luc Thomas, a medical oncologist in the Department of Dermatology of the Hospices Civils de Lyon (France), and principal investigator of the study, commented: "Ipilimumab and other new immunomodulating drugs open a new era in the management of melanoma. However, the low response rates and significant toxicity associated with treatment preclude a wide use of these immunotherapies. The validation of a robust predictive biomarker through precise measurement of patient immune diversity would definitively impact our decision to treat metastatic melanoma patients with immunotherapy."
Nicolas Pasqual, ImmunID's Co-Founder and Chief Scientific Officer explained: "The immune system is key to stay healthy, by protecting us against infections and cancers, but it is fluctuating under certain situation. Anti-cancer immune defenses rely on the diversity of T lymphocytes recognizing the tumor cells, and Ipilimumab targets the CTLA-4 marker on these T cells. Therefore, measuring T cell diversity as a quality biomarker of the specific immune response looks like a relevant tool to help oncologists identify patients who would likely benefit from immunotherapy." Commenting on the study, Bernhard Sixt, Chairman and Chief Executive Officer, added: "The approval of our PREDICT-ID study is an important step for ImmunID, as it will pave the way for EU and US regulatory approval of our ImmunTraCkeR® test in metastatic melanoma. ImmunTraCkeR® is already a CE-marked clinical test kit for monitoring immunotherapies in multiple indications, with proven level 1b evidence according to ASCO guidelines. The proprietary test fits the widely established clinical PCR infrastructure, and as it is patient-specific rather than drug- or disease-specific, it can be applied for prediction of response and monitoring of treatment in a wide range of indications. Immunotherapies are predicted to become the backbone treatment in up to 60% of all cancers, which makes the potential market for ImmunID quite significant."
About Melanoma:
Melanoma is a major public health problem worldwide with an incidence of 191,000 patients in More Developed Regions, and doubling every 10 years (GLOBOCAN 2012, iarc). According to the American Cancer Society, about 76,100 new melanomas will be diagnosed in the US in 2014 and 9,710 people are expected to die from this disease. Melanoma has a very poor prognosis once it becomes metastatic.
About the ImmunTraCkeR® test:
ImmunID has developed the immune molecular diagnostics test ImmunTraCkeR®, which evaluates patient immune competence based on combinatorial T cell diversity. ImmunTraCkeR® is a unique CE-marked diagnostic test, which approaches the disease from the patient immune system's perspective. It is therefore patient-specific, unlike most molecular diagnostics tests, which are either drug- or disease-specific. ImmunTraCkeR® provides information on the patient immune profile, using it as a biomarker for clinical benefit or for risk in patients under immunotherapies. As a new immune companion diagnostic test, ImmunTraCkeR® should answer the urgent medical need for efficient patient stratification tools in melanoma and other solid cancers.
About ImmunID:
ImmunID has been a pioneer in the immune molecular diagnostic field since 2005. Its two clinical products ImmunTraCkeR® and ImmunIG® evaluate patient immune competence based on T and B cell repertoire diversity, respectively. The company is establishing ImmunTraCkeR® as the general immune companion diagnostic for all immunotherapies and setting the general immune molecular diagnostics standard globally. ImmunID collaborates with leading clinical research centers and biopharmaceutical companies worldwide to further validate ImmunTraCkeR® as an immune companion diagnostic test for new immunotherapies and to widen clinical utility of its products. The company is ISO9001 certified and runs an ISO13485 accredited production and R&D facility in the MINATEC high-tech campus in Grenoble, France. In addition, ImmunID has applied for CAP accreditation / CLIA certification of its central lab to be able to provide ImmunTraCkeR® routinely to clinical patients in the United States.
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Bernhard Sixt
Chairman and CEO
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