62% vs. 25% overall response rates with navicixizumab plus paclitaxel in biomarker positive vs. biomarker negative patients using the XernaTM TME Panel
9.2 month vs. 3.9 month median progression free survival in biomarker positive vs. biomarker negative patients using the Xerna TME Panel
Waltham, MA. October 23, 2021 – OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced new biomarker data from a retrospective analysis of results from its Phase 1b clinical trial of navicixizumab in an electronic poster at the European Society of Gynecological Oncology (ESGO) Congress 2021.
Data presented in the poster are from a retrospective analysis of results from an open-label Phase 1b trial evaluating navicixizumab, a potentially first-in-class anti-DLL4/VEGF bispecific antibody targeting tumor vasculature, in combination with paclitaxel in patients with platinum-resistant ovarian cancer (PROC). Pre-treatment biopsies were analyzed using the investigational Xerna TME Panel to retrospectively compare the biomarker classification of patients against clinical outcomes.
“There is a pressing unmet need for new treatments for patients with platinum-resistant ovarian cancer who have progressed on Avastin® or failed more than two lines of prior therapy,” said Dr. Kathleen Moore, Stephenson Cancer Center, Oklahoma. “I believe the data presented at ESGO demonstrated the potential of navicixizumab together with the Xerna TME Panel to help address this need. The response rate and treatment durability of navicixizumab in this heavily pretreated patient population are very exciting and results showed improved outcomes in patients classified as having a high angiogenesis score by the Xerna TME Panel’s novel, RNA-expression based algorithm. We have been searching for a predictive biomarker for anti-angiogenic therapies and the Xerna TME panel results presented at ESGO are very promising.”
Key data and conclusions from the ESGO poster include:
- Clinical outcomes were greater in biomarker positive (B+) vs. biomarker negative (B-) patients
- Overall response rate (ORR) in B+ patients: 62% (8/13)
- ORR in B- patients: 25% (5/20)
- ORR across all patients: 43% (19/44)
- Disease control rate (DCR) in B+ patients: 100% (13/13)
- DCR in B- patients: 65% (13/20)
- DCR across all patients: 77% (34/44)
- A consistent correlation was seen between B+ subtype and improved progression-free survival (PFS)
- Median PFS in B+ patients: 9.2 months (95% confidence interval: 5.5 – not estimable)
- Median PFS in B- patients: 3.9 months (95% confidence interval: 1.8 – 8.9)
Laura Benjamin, Ph.D., President and Chief Executive Officer of OncXerna, commented, “The retrospective biomarker analyses presented at ESGO provide an important point of validation for the development of the Xerna TME Panel. Our next step is to further explore these findings through a prospective Phase 3 trial of navicixizumab plus paclitaxel that is also designed to quantify the Xerna TME Panel’s predictive value. We look forward to the initiation of this trial and the evaluation of our Xerna TME Panel as a potential companion diagnostic for immuno-oncology and anti-angiogenic agents.”
A copy of the ESGO poster (Abstract 918), entitled: “Correlative analyses of a Phase 1b study of navicixizumab plus paclitaxel in patients with platinum-resistant ovarian cancer using the Xerna TME Panel,” can be found here.
About the Phase 1b Trial
The Phase 1b trial was an open-label, non-randomized, dose-escalation and expansion study of the safety, tolerability, and efficacy of navicixizumab plus paclitaxel in patients with platinum-resistant ovarian cancer. The trial enrolled patients who previously received Avastin (bevacizumab) and/or more than 2 prior lines of therapy. Patients were treated with navicixizumab once every two weeks together with weekly paclitaxel. The primary endpoint of the trial was incidence of dose limiting toxicities. Secondary endpoints included response rate assessed by RECIST criteria 1.1 and progression-free survival. For more information, see ClinicalTrials.gov Identifier: NCT03030287.
Navicixizumab is an anti-DLL4/VEGF bispecific antibody product candidate that demonstrated antitumor activity in patients who were previously treated with Avastin® (bevacizumab) in a Phase 1b 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 previously received Avastin and/or more than 2 prior lines of therapy. Navicixizumab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.
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 is an oncology therapeutics company with an innovative precision medicine platform, the Xerna platform. The Xerna platform leverages artificial intelligence technologies to build RNA expression-based biomarker panels that capture the driving biology of an individual tumor in an effort to enable a diagnostic hypothesis for matching patients with drugs targeted to their particular tumor biology. Our current clinical pipeline and first Xerna Panel targets the tumor microenvironment. Our mission is to expand the reach of precision medicine beyond the limited options currently available to address the urgent needs of patients with cancer. By integrating our novel Xerna platform with our deep expertise in clinical development, we believe we can accelerate the development of our novel product candidates and bring meaningful new treatments to patients at an earlier point in time in their disease progression. For more information, please visit oncxerna.com, or follow us on LinkedIn and Twitter.
Investor and Media Contact:
Ashley R. Robinson
LifeSci Partners, LLC