OncXerna Therapeutics Doses First Patient in Phase 2 Trial Evaluating Navicixizumab Alone or in Combination with Chemotherapy in Patients with Select Advanced Solid Tumors
Multicenter basket trial includes cohorts enrolling patients with colorectal and triple negative breast cancer
Trial designed to assess efficacy, safety, and evaluate the relationship between tumor Xerna™ TME Panel biomarker subtype and treatment response
Excerpt from the Press Release:
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 initiation 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 select advanced solid tumors.
The trial is a multicenter, open-label, signal finding study with cohorts in colorectal and triple negative breast cancer currently open for enrollment. 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. Per 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 seeks to evaluate the potential of the Xerna TME Panel to predict clinical benefit from navicixizumab. The Xerna TME Panel is a novel RNA gene expression-based diagnostic panel developed by OncXerna. Samples will be tested using Exact Sciences’ Oncomap™ ExTra with the Xerna TME Panel to classify patient samples into one of four tumor microenvironment (TME) subtypes based on angiogenic and immune gene expression signatures. The relationship between TME subtypes and the anti-tumor activity of studied regimens will be evaluated as a secondary endpoint in the trial.
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