Nodality Inc. Presents Data from Immuno-Oncology Program Applying Company’s Novel Single Cell Network Profiling (SCNP) Platform

Nodality, Inc., which is focused on solving drug development challenges, today announced research results from its lead immuno-oncology efforts based on applications of the Company’s Single Cell Network Profiling (SCNP) technology. SCNP is a multiparametric flow cytometry-based platform that provides robust, human cell-based translational models of disease, drug activity and patient responses. Offering transformative analysis of immune signaling networks at the single cell level, SCNP can reveal both the expression profiles of immunomodulatory receptors (IMRs) within immune cell subsets and the associated signaling profiles in the context of IMR expression. This analysis can provide critical validation for molecular targets in cancer immunotherapy and a platform for the evaluation of therapeutics both in vitro and following clinical administration. Nodality’s platform can be used to determine effects of therapies on immune signaling profiles in primary human immune cells, allowing investigation of immune system dysfunction in cancer and the effects of therapeutics on functional signaling, including the ability to restore signaling to a healthy functional state.

Findings reported in a presentation at the Cambridge Healthtech Institute’s 22nd International Molecular Medicine Tri-Conference (“Tri-Con”) include:

• Nodality has established the capability to profile expression of numerous IMRs, including CTLA-4, PD-1, PD-L1, TIM-3, GITR, OX-40, CD27, 4-1BB, CD40L, LAG3, across multiple immune cell subsets. These cell subsets include the AML blast population, as well as rare cell subsets. Signaling profiles associated with the expression of these IMRs are under investigation.
• Initial analyses have identified that in T cell subsets (CD4+, CD8+) from patients with acute myeloid leukemia (AML), SCNP detected patterns of simultaneous up-regulation of PD-1 with a second IMR – CTLA-4, the molecular target of Ipilimumab – in a subset of AML donor samples when compared with healthy donors. In both healthy and AML donor samples, PD-1+ T cell subsets demonstrated reduced signaling through the T cell receptor (TCR) -modulated MAPK and PI3K pathways. In contrast, cytokine modulated JAK/Stat signaling was elevated in PD-1+ CD4+ T cells, as compared with PD-1-CD4+ T cells. The Company is continuing to analyze signaling profiles in these and additional cell subsets, including the AML blast population, in the context of expression of the additional IMRs.

These and other data were reported by Nodality’s Rachael E. Hawtin, Ph.D., Vice President and Head, Research, in a presentation titled, “Functional Analysis of Disease and Treatment-Associated Changes in Immune Cell and Network Signaling Using Single Cell Network Profiling.” The presentation took place during the Tri-Con session, “Understanding the Molecular Mechanisms of Immunotherapies,” held on February 19. Additionally, Barbara Mittleman, M.D., Nodality’s Vice President, Clinical; Head, Immunology chaired the Tri-Con session, “Combination Immunotherapies,” on February 20.

Dr. Hawtin commented, “Nodality has established new SCNP capabilities, profiling the expression of novel immunotherapy targets in primary human immune cells. Combining these capabilities with our extensive expertise in the analysis of functional immune signaling has enabled the correlation of IMR expression patterns with broad signaling profiles across immune cell subsets, including rare cell subsets. These data can be used in drug development programs to interrogate disease mechanisms, examine the in vitro effects of therapeutic combinations in primary samples, and identify patient sub-populations who may benefit most from these new approaches. Immune monitoring by SCNP of patient samples pre-and post-therapy will enable interrogation of functional effects of clinically administered therapeutics across immune cell subsets, providing a means to identify novel markers of response and further inform combination approaches. We are pleased to present these findings at Tri-Con and look forward to reporting additional progress in the appropriate, peer-reviewed forums.”

Additional Nodality presence at the conference included two presentations: During the “Translational to Clinical R&D” session, Dr. Hawtin delivered a presentation titled, “Single Cell Network Profiling of Primary Human Immune Cells to Bridge the Drug Development Gap between Laboratory and Clinic.” During the “Genomics & Sequencing Data Integration, Analysis and Visualization” session, Dr. Santosh Putta, Nodality’s Vice President, Computational Sciences, delivered a presentation titled, “Analytics of Functional Single Cell Data to Derive Insights into Drug MOA, Disease Profile, and Patient Stratification.” Nodality also showcased its interactive, cloud-based software SCNPDataPortal, which enables the Company’s collaborators access to Nodality’s custom SCNP data analysis and visualization tools. This software provides collaborators with the unprecedented ability to visualize their data in multiple formats, both population-based and at the level of the individual donor, across the multiparametric data sets generated through SCNP analysis.

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.