Nodality, Inc. Announces Data Presentations from Systemic Lupus Erythematosus Collaborative Programs at American College of Rheumatology 2014 Annual Meeting

Nodality, Inc., advancing the discovery, development and use of transformative therapies across broad therapeutic categories, with a focus on immunology and oncology, announced today the presentation of research findings from its collaborative partnership with Pfizer. The collaboration is focused on systemic lupus erythematosus (SLE) product development efforts within Pfizer’s autoimmune R&D groups. The data are being featured at the American College of Rheumatology (ACR) 2014 Annual Meeting, currently taking place in Boston, Massachusetts.

In two posters being presented today (Abstracts #1614 and 1616), Pfizer is reporting the ability of Nodality’s Single Cell Network Profiling (SCNP) technology platform to identify SLE patient subgroups based on disease-specific signaling in immune cells. Continuing elucidation of differential cell signaling has the potential to stratify patient subgroups for enrollment in clinical studies and aid in the selection of treatment regimens.

“A compelling unmet need in the treatment of SLE is the lack of available biomarkers that can better guide treatment, such that current therapies are used empirically and usually guided by symptomatology rather than disease pathogenesis,” commented Peter E Lipsky, M.D., former Chief of the Autoimmunity Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and Editor-in-Chief of Arthritis Research Therapy. “The findings being presented at this year’s ACR clearly indicate a new direction, one in which we can better gauge the specific immune pathways activated or suppressed in the disease state and refine existing therapeutic regimens, as well as advance new candidate compounds targeted at the underlying disease processes. I believe that validation of biomarkers facilitating these advances would be a major step forward in the treatment of SLE.”

“The American College of Rheumatology meeting is an important showcase of results of our collaborations in immunology, a primary disease focus area for Nodality in addition to oncology,” said Laura Brege, CEO and President of Nodality, Inc. “By examining the complex biology and functional consequences of disease-specific signaling at the single-cell level, Nodality’s SCNP platform opens up new opportunities for target characterization and interrogation of drug activity. Ultimately, our goal is to create value across diverse therapeutic landscapes and collaborate with our partners in creating competitive advantages in addressing many of the most pressing challenges in drug R&D.”

Presentations at ACR 2014

• “Functional Analysis of Interferon Responsiveness in PBMC from SLE Donors Identifies Subgroups with Higher and Lower Disease Activity”

  In this study, immune cells (peripheral blood mononuclear cells, or PBMCs) were analyzed from 60 individuals with SLE in comparison to PBMCs from healthy donors. SCNP analysis of the signaling signature in multiple cell subsets found that one-third (20 of 60 patients) demonstrated differentially low interferon-alpha (IFNα) signaling and high interferon-gamma (IFNγ) signaling in B cells. This patient subgroup was more than nine times more likely to be positive for anti-dsDNA antibodies, a specific type of anti-nuclear antibody seen in nearly one-third of SLE patients. The researchers concluded that “refinement of the IFN signature in SLE through SCNP may facilitate the clinical applicability of the signature to better inform patient stratification for treatment options.” The abstract can be found at this link.

  Date: Monday, November 17, 2014, 8:30am – 4:00pm eastern
  Session: Systemic Lupus Erythematosus - Human Etiology and Pathogenesis: Autoimmune Disease Transition, Disease Subsets and Prediction of Flares, Cytokines and Autoantibodies
  Abstract number: 1614
  Location: Boston Convention and Exhibit Center, Exhibit Hall B
  Authors: Rachael Hawtin, Wouter Korver, Erik Evensen, Diane Longo, Drew Hotson, Nikil Wale, Andy Conroy, Alessandra Cesano, Barbara Mittleman, Tsung Lin, Vikram R. Rao, Elena Peeva, Stephen Benoit, Martin Hodge, James D. Clark, Aaron R. Winkler and Jean-Baptiste Telliez

• “Functional Profiling of PBMC from SLE Patients Versus Healthy Controls Identifies Subgroups with Disease-Associated Dysfunctional Signaling”

  This research considered the broad range of signaling differences in the study groups as noted above. In general, signaling was found to be lower in SLE patients’ B and T cells versus health donors. Exceptions were increased interferon-gamma (IFNγ) signaling in B cells and CD45RA+CD4+ T cells; IL-2 signaling was found higher in the latter immune cell subset as well. For the full table of differentiate signaling profiles, please visit this link. The researchers reported ongoing efforts to further explore the clinical relevance of these observations, including the potential identification of novel targets for therapeutic intervention.

  Date: Monday, November 17, 2014, 8:30am – 4:00pm eastern
  Session: Systemic Lupus Erythematosus - Human Etiology and Pathogenesis: Autoimmune Disease Transition, Disease Subsets and Prediction of Flares, Cytokines and Autoantibodies
  Abstract number: 1616
  Location: Boston Convention and Exhibit Center, Exhibit Hall B
  Authors: Rachael Hawtin, Wouter Korver, Erik Evensen, Diane Longo, Drew Hotson, Nikil Wale, Andy Conroy, Alessandra Cesano, Barbara Mittleman, Shirley Tu, Matt Westfall, Tsung Lin, Vik Rao, Elena Peeva, Stephen Benoit, Martin Hodge, James D. Clark, Jean-Baptiste Telliez and Aaron R. Winkler

About Single Cell Network Profiling

Contemporary pharmaceutical research and development remains challenged in producing drugs able to revolutionize the treatment of many of our most intractable diseases. Nodality offers solutions with its Single Cell Network Profiling (SCNP) a multiparametric flow cytometry-based assay that, coupled with Nodality’s proprietary data analysis and visualization tools, uniquely reveals complex functional biology to inform more effective drug development decisions.

Characterizing cell signaling networks in millions of cells at the single cell level, SCNP uses simple blood draw samples and then measures functional pathway signaling in robust, human primary cell-based translational models of disease, drug activity and patient responses. 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 advancing drug discovery, therapeutic development, and precision medicine by delivering critical and clinically actionable information to bridge gaps left by traditional R&D approaches. Nodality’s proprietary functional biology platform, Single Cell Network Profiling (SCNP), provides unprecedented insights into diseases and partners’ product candidates and is applicable through the full discovery and development process, including disease profiling, drug profiling, clinical development, and life cycle management. Nodality’s teams have expertise in achieving solutions across a very broad therapeutic landscape, with a focus on immunology and oncology, including immuno-oncology. SCNP enables smarter spending decisions and is applicable across a very broad therapeutic landscape and throughout the full discovery and development process. 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.