Informing Cancer Immunotherapy Decisions

OncoSeer Diagnostics, Inc.

OncoSeer Diagnostics, Inc. (OncoSeer), a collaboration with UT Southwestern Medical Center (UTSW), is developing multimarker blood tests that diagnose and predict immune related adverse events (irAE) in oncology patients undergoing immune checkpoint inhibitor (ICI) therapy.

Technology

The Problem

  • Immunotherapy (immune checkpoint inhibition) is one of the greatest advances in cancer treatment; however, these promising treatments can cause immune-related adverse events (irAE), which are unpredictable, severe, and potentially fatal attacks on major organ systems
  • Concerns about potential irAE may limit the use of the most promising immune checkpoint inhibitor regimens, thereby limiting the full potential of immunotherapy
  • There are currently no reliable tools for predicting / diagnosing / monitoring irAE

The Solution

  • We are developing a Cancer Immunotherapy Toxicity Prediction blood test that will identify patients who are likely to develop irAE
  • This prediction allows physicians and patients to make informed decisions on the use of immunotherapy
  • Expanded use: Early-stage cancer & History of autoimmune disease
  • Modified use or increased monitoring: Patients at high risk of toxicity

OncoSeer Overview

  • UT Southwestern spin-out, founded in 2022
  • Multiple grant awards including the National Institutes of Health and the American Cancer Society
  • Published in prominent peer-reviewed journals
  • Renowned Physician and Research Team specializing in Oncology, Molecular Biology, and Bioinformatics
  • Scientific Advisory Board consisting of leaders in oncology, immunology and bioinformatics
  • CEO and Board of Directors consisting of business leaders with extensive experience in early-stage startups

UNMET CLINICAL NEED

  • 1.9 million new cancer cases per year in the US
  • 0.76 million (40%) of cancer patients eligible for checkpoint inhibitor drugs
  • Current ICI global market is $37 billion (2022) and is projected to be $148 billion in 10 years (2030)
  • Up to 40% of patients on checkpoint inhibitors have toxicity (immune related adverse events - irAE)
  • Patients with irAE have higher cost of medical care
  • Patients with irAE have longer length of hospitalization

American Cancer Society. Cancer Facts and Figures 2022 Haslam & Prasad. JAMA Network Open 2019;2(5): e192535 Zheng etal.The Oncologist 2021; 26:e2002-2012

Literature Citations

Shaheen Khan , Saad A. Khan, Xin Luo, Farjana J. Fattah, Jessica Saltarski, Yvonne Gloria-McCutchen , Rong Lu, Yang Xie, Quan Li, Edward Wakeland and David E. Gerber

Immune Dysregulation in Cancer Patients Developing Immune-Related Adverse Events

Up to 40% of cancer patients on immune checkpoint inhibitors develop clinically significant immune-related adverse events (irAEs). The role of host immune status and function in predisposing patients to the development of irAEs remains unknown

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David Hsiehchen, MD; Mary K. Watters, MD; Rong Lu, PhD; Yang Xie, PhD; David E. Gerber, MD

Variation in the Assessment of Immune-Related Adverse Event Occurrence, Grade, and Timing in Patients Receiving Immune Checkpoint Inhibitors

Toxic effects of conventional chemotherapy and molecularly targeted cancer therapies are generally well defined and occur at predictable points. By contrast, owing to their heterogeneous manifestations, unpredictable timing, and clinical overlap with other conditions, immune-related adverse events (irAE) may be more difficult to diagnose and characterize.

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Shaheen Khan, Mitchell S. von Itzstein, Rong Lu, Bonnie L. Bermas, David R. Karp, Saad A. Khan, Farjana J. Fattah, Jason Y. Park, Jessica M. Saltarski, Yvonne Gloria‐McCutchen, Yang Xie, Quan‐Zhen Li, Edward K. Wakeland, David E. Gerber,

Late‐Onset Immunotherapy Toxicity and Delayed Autoantibody Changes: Checkpoint Inhibitor–Induced Raynaud's‐Like Phenomenon

Immune checkpoint inhibitor (ICI)-induced immune-related adverse events (irAEs) may affect almost any organ system and occur at any point during therapy. Autoantibody analysis may provide insight into the mechanism, nature, and timing of these events.

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Amrit S Gonugunta ,Mitchell S von Itzstein, Hong MuMosley , Farjana Fattah, J David Farrar, Angela Mobely, Sawsan Rashdan, Sunny Lai, Salman F Bhai, Bonnie L Bermas,David Karp, Quan-Zhen Li, Edward K Wakeland, David E Gerber

Humoral and Cellular Correlates of a Novel Immune-Related Adverse Event and its Treatment

While immune checkpoint inhibitors (ICI) have revolutionized the treatment of cancer, associated toxicities termed immune-related adverse events (irAE) occur in a substantial proportion of patients. These autoimmune events may affect almost any organ system.

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Jared Ostmeyer, Jason Y Park, Mitchell S von Itzstein, David Hsiehchen, Farjana Fattah, Mary Gwin, Rodrigo Catalan, Shaheen Khan, Prithvi Raj, Edward K Wakeland, Yang Xie, David E Gerber

T-cell tolerant fraction as a predictor of immune-related adverse events

Background Immune checkpoint inhibitor (ICI) therapies may cause unpredictable and potentially severe autoimmune toxicities termed immune-related adverse events (irAEs). Because T cells mediate ICI effects, T cell profiling may provide insight into the risk of irAEs. 

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Jeffrey M. Stone Co-Founder, CEO & Board Member

MAILING ADDRESS

BioLabs NTX at Pegasus Park
3060 Pegasus Park Drive Building 6
Dallas, Texas 75247

Informing Cancer Immunotherapy Decisions

214-704-5000

jeff@jmscapitalinc.com

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