OncXerna Therapeutics Provides New Results from its Xerna™ RNA-based Biomarker Platform at the AACR Annual Meeting

Xerna™ TME Panel describes the tumor microenvironment based on dominant biology subtypes with prognostic capabilities in colorectal cancer

Data supports the application of Xerna™ TME Panel beyond gastric and ovarian cancers for prospectively-driven trials with OncXerna’s clinical-stage programs

WALTHAM, Mass., April 10, 2021 (GLOBE NEWSWIRE) — OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its first-in-class targeted oncology therapies, today presented new results from its Xerna™ TME Panel during Week 1 of the American Association for Cancer Research (AACR) Annual Meeting. In this study, OncXerna demonstrated that the first panel (TME Panel) from its Xerna™ platform revealed prognostic subtypes in colorectal cancer (CRC) by analyzing tumor samples from over 600 CRC patients. The Xerna™ TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on their dominant biologies of the tumor microenvironment (TME), and has been developed as a clinical assay.

“Our goal is to expand the applicability of precision medicine in cancer through a novel approach that matches patients to the appropriate therapies by using RNA expression to identify patients with common biological drivers,” said Laura Benjamin, Ph.D., President and Chief Executive Officer at OncXerna Therapeutics. “In our AACR presentation, we presented results that verify the capabilities of our TME Panel and enable its expanded use for patients with colorectal cancer. These exciting findings pave the way for future prospectively-driven trials with the Xerna™ TME Panel and our clinical-stage programs, navicixizumab and bavituximab.”

The results from the study presented at this year’s AACR Annual Meeting revealed:

• An expansion of the TME Panel’s capabilities to include CRC, as the RNA-based gene signature identified unique subtypes of patients with angiogenic and immune biologies that dominated the stroma. These biologies were prognostic for recurrence-free and overall survival, supporting the potential use of the TME Panel as a novel, pan-tumor biomarker.
• A comparison of the TME Panel’s subtypes to the Consensus Molecular Subtypes (CMS) model. The CMS model represents gene expression data from both colorectal cancer cells and their microenvironment. In contrast, the Xerna™ TME Panel integrates the interplay of angiogenic and immunogenic properties of the tumor microenvironment, and because of this focus, could be more predictive for treatments that target angiogenic and immunogenic properties of the TME.

The following two datasets were used to explore the application of the TME Panel in colorectal cancer: 1) A public dataset from the Cartes d’Identite des Tumeurs (CIT) containing 566 primary tumor samples collected from patients with stage 1-4 CRC between 1988 and 2007 in France, and 2) A proprietary collection of 92 samples from the Wood Hudson Cancer Research Laboratory (WH) of patients with metastatic CRC who were treated with various regimens including targeted therapies following surgery.

OncXerna’s electronic poster, #348 entitled: “RNA-based Diagnostic Panel Matches TME Phenotype to Therapeutic Mechanism of Action in Colorectal Cancer,” is included in the “Biomarkers Predictive of Therapeutic Benefit” poster session at the AACR annual meeting. A link to the poster can be found here.

About OncXerna Therapeutics, its Xerna™ RNA-based Biomarker Platform, and Xerna™ TME Panel

OncXerna plans to deliver next-generation precision medicine to a larger group of cancer patients by leveraging the company’s Xerna™ platform to prospectively identify patients based on the dominant biology of their cancer. This allows OncXerna to pair those patients with OncXerna’s clinical-stage therapies and known mechanism of action that directly address these biologies, to dramatically improve patient outcomes. 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 TME, and has been developed as a clinical assay. The Xerna™ TME Panel is an investigational assay that has not been licensed or approved, and has not been demonstrated to be safe or effective for any use.

For more information on OncXerna, please visit oncxerna.com

About Navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody that demonstrated antitumor activity in patients who have progressed on Avastin^® (bevacizumab) in a Phase 1a/b clinical trial. The U.S. Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal, or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with Avastin. OncXerna is targeting patients whose dominant tumor biology is driven by angiogenesis with a focus beyond VEGF to include broader anti-angiogenic pathways. Navicixizumab is an investigational agent that has not been licensed or approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.

About Bavituximab

Bavituximab is an antibody that reverses 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. The mechanism of action of bavituximab is to block tumor immune suppression signaling from PS to multiple immune cell receptor families (e.g., TIMs and TAMs). The dominant biology targeted by bavituximab may be relevant for patients with many types of solid tumors whose immune systems are too suppressed to benefit from currently available immune oncology therapies. OncXerna’s clinical trials currently combine bavituximab with KEYTRUDA^® to test the hypothesis that relieving immunosuppression can enhance responses to checkpoint inhibitors. Bavituximab is an investigational agent that has not been licensed or approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced gastric cancer.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Investor and Media Contact:

Ashley R. Robinson
LifeSci Partners, LLC
arr@lifesciadvisors.com