Biological tests developed using Nodality's Single Cell Network Profiling (SCNP) technology have the potential to inform clinical treatment decisions.
Acute myeloid leukemia (AML) is a disease in which the patient's bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. There are approximately 27,000 AML patients in the U.S.; approximately 12,000 are diagnosed each year with an average age of 67 at diagnosis. AML is considered a medical crisis and immediate treatment is required to reduce the risk of mortality. Standard AML treatment begins with induction therapy, cytarabine combined with an anthracycline (such as daunorubicin or idarubicin), which aims to achieve complete remission. Up to 65% of patients achieve a complete response. However, the treatment itself is very toxic.
A first application of Nodality's approach is an SCNP-based test to predict response to induction chemotherapy in patients with AML. Each patient's cells have a distinct signaling network functional signature due to signaling pathway dysregulation leading to their disease state; this signature can be used to predict the effect of particular therapies on these cells. A test to predict response to induction chemotherapy has the potential to increase efficiency of chemotherapy: predicted responders are more likely to receive induction therapy and be confident that the toxicity of the regimen is worthwhile given the likely benefit. Those predicted to not respond have the potential to go directly onto clinical trials with potential for clinical response.
Nodality has validated a test for prediction of response to chemotherapy in pediatric AML. Nodality is currently conducting validation studies to predict response to therapy in adults with AML. These tests are developed through a series of clinical studies in which SCNP is used to reveal pathways associated with clinical outcomes and then tested in separate clinical trials with independent samples. The same development paradigm can be used for test development in other therapeutic areas such as autoimmune diseases and other forms of cancer.