Informing Cancer Immunotherapy Decisions

OncoSeer Diagnostics, Inc.

OncoSeer Diagnostics, Inc. (OncoSeer), a collaboration with UT Southwestern Medical Center (UTSW), is developing multimarker tests to help predict, monitor, diagnose, and treat immune related adverse events (irAE) in patients receiving 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

KNOW MORE

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.

KNOW MORE

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.

KNOW MORE

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.

KNOW MORE

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. 

KNOW MORE
Mitchell S. von Itzstein, Yuqiu Yang, Yiqing Wang, David Hsiehchen, Thomas Y. Sheffield, Farjana Fattah, Vinita Popat, Murtaza Ahmed, Jade Homsi, Jonathan E. Dowell, Sawsan Rashdan, Jay Lohrey, Hans J. Hammers, Randall S. Hughes, Tao Wang, Yang Xie, David E. Gerber

Highly variable timing renders immunotherapy efficacy and toxicity impractical biomarkers of one another in clinical practice

A useful clinical biomarker requires not only association but also a consistent temporal relationship. For instance, chemotherapy-induced neutropenia and epidermal growth-factor inhibitor-related acneiform rash both occur within weeks of treatment initiation, thereby providing information prior to efficacy assessment.

KNOW MORE
Bing Song, Kaiwen Wang, Saiyang Na, Jia Yao, Farjana J. Fattah, Alexandra L. Martin, Mitchell S. von Itzstein, Donghan M. Yang, Jialiang Liu, Yaming Xue, Chaoying Liang, Yuzhi Guo, Indu Raman, Chengsong Zhu, Jonathan E. Dowell, Jade Homsi, Sawsan Rashdan, Shengjie Yang, Mary E. Gwin, Tuoqi Wu, David Hsiehchen, Yvonne Gloria-McCutchen, Catherine Pei-ju Lu, Prithvi Raj, David E. Gerber, Tao Wang

Profiling antigen-binding affinity of B cell repertoires in tumors by deep learning predicts immune-checkpoint inhibitor treatment outcomes

The capability to profile the landscape of antigen-binding affinities of a vast number of antibodies (B cell receptors, BCRs) will provide a powerful tool to reveal biological insights. 

KNOW MORE

Shaheen Khan, Venkat S Malladi, Mitchell S von Itzstein, Hong Mu-Mosley, Farjana J Fattah, Yang Liu, Mary E Gwin, Jason Y Park, Suzanne M Cole, Sheena Bhalla, Jay Lohrey, David Hsiehchen, Angela Moses, Tao Wang, Yaming Xue, Angela B Mobley, J David Farrar, Marjaan Imam, Michelle Wu, Quan-Zhen Li, Edward K Wakeland, Yang Xie, Jeffrey A SoRelle, David E Gerber

Innate and adaptive immune features associated with immune-related adverse events

Background While highly efficacious for numerous cancers, immune checkpoint inhibitors (ICIs) can cause unpredictable and potentially severe immune-related adverse events (irAEs), underscoring the need to understand irAE biology.

KNOW MORE
Prithvi Raj , Jialiang Liu, Chengsong Zhu, Carlos Arana, Farjana J Fattah, Hong Mu-Mosley, Benjamin Switzer , Jason Y Park, Mitchell S von Itzstein, Edward K Wakeland, Igor Puzanov , Yousef Zakharia , Gregory A Daniels, Montaser F Shaheen, Yang Xie, Jeffrey A SoRelle,David E Gerber

Genetic haplotypes in VWA8, OSBPL6, and ADAMTS9-AS2 are associated with immune-related adverse effects in ICI-treated patients with cancer

Background Immune-related adverse events (irAEs) remain largely unpredictable, potentially affecting multiple organ systems and occurring at almost any point during and even occasionally after immune checkpoint inhibitor (ICI) treatment. To identify populations at risk for these immune-mediated toxicities, we analyzed genetic characteristics and immune markers associated with clinically significant irAEs.

KNOW MORE

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

Contact Us

Informing Cancer Immunotherapy Decisions

Quick Links

Useful Links

@ copyright 2023