OncXerna Therapeutics Administers First Patient in Phase 2 Trial Evaluating Navicixizumab Alone or in Combination With Chemotherapy in Patients With Certain Advanced Solid Tumors

Multi-center basket trial includes cohorts recruiting patients with colorectal cancer and triple-negative breast cancer

Trial Designed to Evaluate Efficacy, Safety, and Assess the Relationship Between Xerna™ TME Panel Tumor Biomarker Subtype and Treatment Response

WALTHAM, Mass., Sept. 08, 2022 (GLOBE NEWSWIRE) — 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 the start of dosing in a Phase 2 basket trial evaluating the anti-DLL4/VEGF bispecific antibody navicixizumab, alone or in combination with chemotherapy, in patients with certain advanced solid tumors.

The trial is a multicenter, open-label, signal-finding study with colorectal cancer and triple-negative breast cancer cohorts currently open for recruitment. The colorectal cancer cohort is evaluating navicixizumab alone and in combination with irinotecan, while the triple-negative breast cancer cohort is evaluating navicixizumab alone and in combination with paclitaxel. Depending on the trial protocol, two additional cohorts designed to enroll patients with ovarian cancer and gastric or gastroesophageal cancer may be opened in the future.

In addition to evaluating the safety and efficacy of the studied treatment regimens, the basket trial also aims to assess the potential of the Xerna TME group to predict the clinical benefit of navicixizumab. The Xerna TME panel is a new diagnostic panel based on RNA gene expression developed by OncXerna. Samples will be tested using Oncomap™ ExTra from Exact Sciences with the Xerna TME panel to classify patient samples into one of four tumor microenvironment (TME) subtypes based on expression signatures angiogenic and immune genes. The relationship between TME subtypes and the antitumor activity of the studied treatment regimens will be assessed as a secondary endpoint in the trial.

“Aberrant Notch expression is associated with poor prognosis and treatment resistance in many solid tumors, including colorectal cancer and triple-negative breast cancer. Navicixizumab simultaneously targets the inhibition of DLL4, a Notch pathway ligand, and VEGF, making it a very attractive therapeutic strategy to evaluate,” said Paul Oberstein, MD, director of GI medical oncology at Perlmutter. Cancer Center and Associate Professor of Medicine at NYU Langone Santé. “We are excited to have this study ongoing and look forward to evaluating the potential clinical impact of navicixizumab in these settings where patients have limited treatment options and poor prognosis.”

Laura Benjamin, Ph.D., President and CEO of OncXerna, said, “This Phase 2 trial is an important milestone for the development of navicixizumab as we seek to build on our promising breast cancer data. ovary and explore its potential to address unmet needs in other settings. where DLL4 plays a key role in treatment resistance. As part of our company’s commitment to developing precision medicine to improve patient outcomes, we will also evaluate the potential of the Xerna TME panel to identify patients most likely to respond to navicixizumab treatment.

About thePhase 2 trial

The Phase 2 basket trial (ONCX-NAV-G201) is a multicenter, open-label, signal-finding study designed to enroll up to 180 patients in four cohorts:

  • Colorectal Cancer Cohort: Designed to evaluate navicixizumab alone and in combination with irinotecan in patients with colorectal cancer who have failed two lines of prior standard therapy, including prior therapy with bevacizumab or equivalent antibody. This cohort will recruit up to 60 patients.
  • Triple Negative Breast Cancer Cohort: Designed to evaluate navicixizumab alone and in combination with paclitaxel in patients with triple-negative breast cancer who have received at least two and no more than four prior lines of standard therapy for metastatic disease. According to the trial inclusion criteria, prior therapy should include both an immune checkpoint inhibitor in patients with a combined positive score >10 and sacituzumab govitecan. This cohort will recruit up to 60 patients.
  • Gastric/gastroesophageal cancer cohort: Designed to evaluate navicixizumab plus paclitaxel in patients with second-line gastric or gastroesophageal cancer whose prior therapy included an immune checkpoint inhibitor. This cohort will recruit up to 30 patients.
  • Ovarian Cancer Cohort: Designed to evaluate navicixizumab monotherapy in patients with relapsed/refractory ovarian cancer who have received at least two and no more than five lines of standard therapy. This cohort will recruit up to 30 patients.

The primary endpoints of the trial are objective response rate and progression-free survival. Key secondary endpoints include overall survival, duration of response, safety and tolerability assessments, and the relationship between Xerna TME Panel tumor biomarker subtype and antitumor activity of treatment regimens studied. Xerna TME Panel assessments will be performed using formalin-fixed paraffin-embedded archives or baseline tumor specimens collected during screening. For more information about the trial, see the Clinicaltrials.gov identifier: NCT05453825.

About navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody product candidate that has demonstrated antitumor activity in patients previously treated with Avastin® (bevacizumab) in a phase 1b clinical trial. The United States Food and Drug Administration has granted Fast Track Designation to navicixizumab for the treatment of high-grade cancer of the ovary, primary peritoneum, or fallopian tubes in patients who have received at least three prior therapies and/or or previous treatment with Avastin®. Navicixizumab is an investigational agent that has not been approved and has not been shown 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 the dominant angiogenic and immunogenic tumor microenvironment (TME) biology. The Xerna TME Panel is an investigational test 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 precision medical oncology company developing novel therapies to treat solid tumors. Using its innovative precision medicine platform (Xerna™), OncXerna leverages artificial intelligence technologies and RNA expression-based biomarkers to match a specific patient’s tumor with the most suitable drugs to treat this tumor. By integrating the Xerna platform with our deep expertise in clinical development, we believe we can accelerate the development, approval and commercialization of drug candidates and bring meaningful new treatments to patients as soon as possible. OncXerna’s lead product candidate, navicixizumab, is a bispecific antibody that inhibits both DLL4 and VEGF and is currently being studied in ovarian cancer, triple-negative breast cancer and colorectal cancer . Another product candidate, bavituximab, is an antibody designed to reverse immune suppression by inhibiting phosphatidylserine signaling and is currently in Phase 2 clinical trials. Navicixizumab and bavituximab are investigational agents that do not have not been approved and have not been shown to be safe or effective for any use. For more information, please visit oncxerna.comor follow us on LinkedIn and Twitter.

Investor and media contact:

Ashley R. Robinson
LifeSci Partners, LLC
[email protected]


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