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.
About Nodality
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.
Copyright Business Wire 2015