Celcuity is a cellular analysis company developing companion diagnostic tests that identify new patient populations for targeted therapies. Our proprietary CELx signaling function diagnostic platform uses a patient’s living tumor cells to identify the specific abnormal cellular activity driving their cancer and the targeted therapy that can best treat it. This enables us to develop tests that diagnose new cancer sub-types molecular diagnostics cannot detect and to measure directly the effectiveness of the matching targeted therapy in a patient’s living tumor cells. Celcuity was cofounded in 2012 by Brian Sullivan and Lance Laing, Ph.D. and is based in Minneapolis, Minnesota.

Our first test, the CELx Multi-Pathway (MP) Signaling Function Test for breast cancer, measures HER1, HER2, HER3, and c-Met signaling activity in a patient’s live tumor cells. Abnormal activity in these pathways, which are key cellular processes that regulate cell proliferation, can play a role in many breast cancers. With this test, we identify two new sub-types of breast cancer that traditional molecular diagnostics cannot diagnose.

Hyperactive HER2-driven signaling tumors
Traditional molecular tests used to diagnose HER2-related breast cancer only measure the status of a single cellular component, HER2 protein. If these molecular diagnostics find excess HER2 protein levels in a patient’s tumor cells, patients are diagnosed with HER2 breast cancer (HER2+) and are then treated with anti-HER2 targeted therapies. However, several clinical trials found that a sub-group of patients with normal HER2 protein levels (HER2-negative) respond to anti-HER2 therapies, revealing that measuring HER2 protein levels alone misses patients who have HER2-driven breast cancer. To provide a more complete diagnosis for HER2-negative breast cancer patients, our CELx test determines whether the HER2 signaling network in a patient’s tumor cells is functioning abnormally. We believe these patients are likely to respond to the same anti-HER2 therapies only HER2+ patients receive today.
Hyperactive and co-activated HER-family and c-Met signaling driven tumors
Hyperactive c-Met signaling, including cross-talk between c-Met and HER family receptors, has long been suspected of playing a role in a variety of cancer types. However, no current tests today are used to identify breast cancer patients eligible for treatment with anti-c-Met targeted therapies alone or in combination with other drugs. Our CELx Test evaluates independent c-Met pathway signaling activity and its involvement with HER family signaling in HER2-negative breast cancer tumor cells to identify patients with hyperactive c-Met and HER family signaling. We believe these patients are likely to respond to treatment with a combination of c-Met and pan-HER inhibitors.

Celcuity is currently collaborating with pharmaceutical companies to evaluate the efficacy of their targeted therapies in patients diagnosed with one of these two cancer sub-types. We are also conducting on-going research to develop tests for additional signaling pathways and solid tumor types.

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