AI-driven Xerna TME panel generates robust “binary-like” biomarker classifications that are prognostic across multiple tumor types
Xerna TME Panel has potential to predict patient responses to angiogenic- and immune-targeted therapies
Waltham, MA. April 11, 2022 – OncXerna Therapeutics, Inc. (“OncXerna”) is a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates. Today the company announced biomarker data demonstrating the Xerna TME Panel’s prognostic value across multiple indications in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting. Data also suggest the potential for Xerna TME Panel to predict patients most likely to benefit from immune- and angiogenic-targeted therapy.
The Xerna TME Panel analyzes proprietary RNA-based gene expression data, which is inherently continuous, with a machine learning-based algorithm to classify patients into distinct subtypes based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). This enables potential for patients to be matched with targeted therapies that directly address their dominant biology and expand the reach of precision medicine to significantly more patients.
RNA expression signatures to predict therapeutic response have struggled with defining thresholds that clearly distinguish patients more likely to benefit from those that are not. RNA sequencing datasets are complex, and linear statistical tests used to set thresholds have proved difficult to reproduce across multiple studies. “Using artificial intelligence, we have been able to unlock the potential of RNA-based expression gene signatures,” said Laura Benjamin, CEO of OncXerna Therapeutics. “We have achieved nearly binary outcomes with the Xerna TME panel that are similar to DNA-sequencing that detects the presence or absence of a specific mutation. This allows us to use our panel as a robust pan-tumor biomarker platform and potential to predict patient response to multiple targeted oncology drugs.”
Data featured in the AACR poster show the Xerna TME Panel is robust, resulting in high confidence scores and a lack of indeterminate or ambiguous calls when classifying subjects into biomarker types. The lack of reliable biomarkers to predict responses to anti-angiogenic treatment is a significant unmet medical need. When the Xerna TME Panel was applied to a cohort of gastric cancer patients treated with an anti-angiogenic agent (ramucirumab), the panel showed potential to predict clinical benefit. In a separate gastric cancer cohort treated with immune checkpoint inhibitor monotherapy, the panel had better positive predictive value (PPV) than PD-L1, and better sensitivity than MSI-H. Both PD-L1 and MSI-H rely on setting thresholds in a continuous variable space. Xerna TME Panel classifications were also shown to be prognostic in second-line gastric cancer patients receiving chemotherapy and/or radiation, and in melanoma and colorectal cancer cohorts.
The Xerna TME Panel has been licensed to Qiagen and Exact Sciences, who will partner with OncXerna to support clinical trials for OncXerna’s two clinical stage compounds, Navicixizumab and Bavituximab. Through their partnerships with OncXerna, Qiagen and Exact Sciences also intend to support the development of compounds from other companies, including novel immune-targeting agents.
An electronic copy of the AACR poster entitled “Xerna™ TME Panel: A Pan-Cancer RNA-Based Investigational Assay Designed to Predict Patient Responses to Angiogenic and Immune Targeted Therapies,” is available to registered attendees of the AACR annual meeting on the meeting website, as well as on the OncXerna website here. The in-person presentation will take place during the “Biomarkers Predictive of Therapeutic Benefit 1” poster session on April 11, 2022, from 9:00 AM – 12:30 PM CT.
About the Xerna TME Panel
The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.
About OncXerna Therapeutics
OncXerna Therapeutics is a clinical stage oncology company developing novel monoclonal antibodies to treat solid tumors. In combination with its innovative precision medicine platform, the Xerna TME Panel, OncXerna leverages artificial intelligence technologies and RNA expression-based biomarkers to match a specific patient’s tumor with the drugs best suited to treat that tumor. By integrating our novel Xerna TME Platform with our deep expertise in clinical development, we believe we can accelerate the development, approval and commercialization of drug product candidates and bring meaningful new treatments to patients as soon as possible. Our current clinical pipeline includes the company’s lead product candidate, Navicixizumab, which is a bispecific antibody that targets both VEGF and DLL4 to treat solid tumors and is currently entering a Phase 2/3 study for the treatment of advanced ovarian cancer. Another product candidate, Bavituximab, is an investigational antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling and is currently in Phase 2 clinical trials to treat a specific subset of patients with advanced gastric cancer to improve their response to anti-PD-1 treatment. Navicixizumab and Bavituximab are investigational agents that have not been approved and have not been demonstrated to be safe or effective for any use. For more information, please visit oncxerna.com, or follow us on LinkedIn and Twitter.
Investor and Media Contact:
Ashley R. Robinson
LifeSci Partners, LLC