SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nodality, Inc., today announced publication of data in the journal PLOS ONE detailing the clinical validation of the Company’s Single Cell Network Profiling (SCNP)-based diagnostic classifier for prediction of response to standard induction therapy (cytarabine (Ara-C)-based chemotherapy) in elderly patients with Acute Myeloid Leukemia (AML). SCNP is a multiparametric flow cytometry-based platform that provides robust, human cell-based translational models of disease, drug activity and patient responses, and the company is focused on applying SCNP to solve drug development and treatment challenges. Nodality’s classifier is designed to aid clinicians in treatment options by providing predictive information concerning the likelihood of patients achieving a complete response to standard induction therapy. This predictive information is clinically important in AML where treatment itself has at best a 50% chance of effect and is associated with high morbidity and approximately 15-25% mortality.
In the paper, titled “Cell Signaling-Based Classifier Predicts Response to Induction Therapy in Elderly Patients with Acute Myeloid Leukemia,” DOI: 10.1371/journal.pone.0118485, researchers present findings related to the training, verification and clinical validation of the accuracy of Nodality’s predictive AML test. The study tested cryopreserved peripheral blood and bone marrow samples collected at the time of diagnosis from AML patients >55 years old enrolled in four clinical trials conducted by SWOG and one clinical trial conducted by ECOG. The results showed that the SCNP classifier is a significant predictor of the response to therapy (AUROC=0.72, p=0.02, N=42) in bone marrow samples collected from AML patients >55 years old.
Importantly, a second classifier developed using only clinical and molecular inputs currently in use for AML lacked prediction accuracy, and the SCNP-based classifier was still significant in predicting response after controlling for these clinical and molecular inputs.
Laura Brege, CEO and President of Nodality, Inc., stated, “Complete remission rates in Elderly AML patients ranges from 35 to 50%. These results show that the SCNP assay provides accurate data on functional disease biology that is independent of traditional tests. It has the potential to help inform treatment choices by avoiding potentially harmful treatment. Those patients might then be considered for enrollment on clinical trials evaluating newer, targeted treatments.”
About Single Cell Network Profiling
Nodality’s proprietary Single Cell Network Profiling (SCNP) technology, a multiparametric flow cytometry-based platform, provides robust, human cell-based translational models of disease, drug activity and patient responses. SCNP reveals complex biology by characterizing cell signaling networks in millions of cells at the single cell level. It creates competitive advantages in addressing many of the most pressing challenges in drug discovery and development. SCNP technology, coupled with Nodality’s proprietary data analysis and visualization tools, uniquely reveals complex functional biology to inform more effective drug development decisions.
Originally developed at Stanford University, SCNP does not require physical isolation of cell subsets and therefore provides real time information on cell-cell interactions, identifies the functional signaling capacity of rare cell subsets (such as drug-resistant cells and stem cell populations) reveals the functional consequences of epigenetic mutations and enables the interrogation of immune cell communication and dysfunction in disease.
Nodality is a life science company whose technology platform, SCNP, bridges the gap left by traditional R&D approaches. Nodality provides clinically actionable solutions throughout the full discovery and development process, including disease profiling, drug profiling, clinical development, and life cycle management. Nodality’s team has expertise in identifying solutions across a broad therapeutic landscape, with a focus on immunology and oncology, including immuno-oncology. Nodality has established multi-year strategic collaborations with UCB Pharma S.A. (Euronext Brussels: UCB), Pfizer (NYSE: PFE) and Johnson & Johnson (NYSE: JNJ), utilizing its SCNP technology to assist the discovery and development of new therapeutic compounds. Major investors include Kleiner Perkins, TPG Biotech, Maverick, Pfizer, and LabCorp.
For more information on Nodality, please visit www.nodality.com.