A new study called PREDICT-ID Melanoma is going to assess the predictive value of immune profiles for response to the drug agent ipilimumab. The company that developed this agent, ImmunID, is a pioneer in the global immune Molecular Diagnostic (iMDx) field.
The PREDICT-ID melanoma clinical trial has just been authorized by French regulatory bodies and is going to start in January 2015, where 200 patients treated with ipilimumab will be evaluated. An immune molecular diagnostics test called ImmunTraCkeR, also developed by ImmunID, will be performed at baseline before ipilimumab intake and also during the course of treatment, until response assessment.
ImmunTraCkeR assesses a patient’s immune profile, with a biomarker for clinical benefit or for inherent risk, in patients undergoing immunotherapies, and aims to be an effective method for patient stratification in melanoma and other types of cancers.
In a recent press release, Dr. Luc Thomas, from the Department of Dermatology of the Hospices Civils de Lyon said, “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.”
The company’s main target is metastatic melanoma, a highly prevalent and deadly cancer with a rising trend. A recent clinical trial using immunotherapy in this type cancer (with ipilimumab, nivolumab and pembrolizumab, amongst other immune checkpoint inhibitors), revealed benefits in using the body’s own immune system against melanoma. However, these therapies can cause serious side effects and only a small proportion of patients with melanoma find these immunotherapies beneficial.
Importantly, a recent case study found that it is feasible to stratify non-responders to ipilimumab using the ImmunTraCkeR test. As such, ImmunID is going to examine the use of patients’ immune profiles with ImmunTraCkeR as a predictive biomarker of response to ipilimumab in metastatic melanoma.
Nicolas Pasqual, ImmunID’s Co-Founder comented, “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.”
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.”