Primary Peritoneal High-Grade Serous Adenocarcinoma

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 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. “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 inhibition of DLL4, a ligand of the Notch pathway, and VEGF, making this a very attractive therapeutic strategy to evaluate,” said Paul Oberstein, M.D., Director of GI Medical Oncology in the Perlmutter Cancer Center and Associate Professor of Medicine at NYU Langone Health. “We are excited to have this study underway and look forward to evaluating the potential clinical impact of navicixizumab in these settings where patients have limited treatment options and prognosis is poor.” Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna, commented, “This Phase 2 trial is an important milestone for navicixizumab’s development as we seek to build on our promising ovarian cancer data 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 expand precision medicine to improve outcomes for patients, we will also evaluate the potential of the Xerna TME Panel to identify patients more likely to respond to treatment with navicixizumab.” 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 across 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 treatment with prior bevacizumab or an equivalent antibody. This cohort will enroll 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. Per the trial’s inclusion criteria, prior therapy must include both an immune checkpoint inhibitor in patients with combined positive score > 10, and sacituzumab govitecan. This cohort will enroll 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 enroll 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 prior lines of standard therapy. This cohort will enroll 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 tumor Xerna TME Panel biomarker subtype and the anti-tumor activity of studied regimens. Xerna TME Panel assessments will be made using formalin-fixed paraffin embedded archive or core tumor samples collected during screening. For more information on the trial, see Clinicaltrials.gov Identifier: NCT05453825. About Navicixizumab 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 received at least three prior therapies and/or prior treatment with Avastin®. 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 Therapeutics is a clinical stage precision medicine oncology company developing novel therapies to treat solid tumors. Utilizing 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 drugs best suited to treat that 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 product 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 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 arr@lifesciadvisors.com

62% vs. 25% overall response rates with navicixizumab plus paclitaxel in biomarker positive vs. biomarker negative patients using the Xerna™ 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, Mass., Oct. 23, 2021 (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 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 Gynaecological 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. About Navicixizumab 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 arr@lifesciadvisors.com

Aug. 9, 2021 20:05 UTC QIAGEN and OncXerna enter into a global master agreement to advance the development of the Xerna™ TME panel as a potential Next Generation Sequencing (NGS) companion diagnostic for OncXerna’s Navicixizumab Agreements include a non-exclusive license for QIAGEN to the OncXerna Xerna™ TME panel The agreements broaden QIAGEN’s NGS companion diagnostics capabilities in immuno- oncology clinical development programs HILDEN, Germany & WALTHAM, Mass. & GERMANTOWN, Md.--(BUSINESS WIRE)--QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) and 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 signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna™ TME panel. QIAGEN and OncXerna have agreed to collaborate to advance the Xerna™ TME panel towards IVD (in-vitro diagnostic) regulatory approval as a NGS companion diagnostic for Navicixizumab, which is being developed by OncXerna as a treatment for patients with ovarian cancer. The diagnostic will be used to determine if patients with ovarian cancer whose dominant tumor biology is driven by angiogenesis are more likely to benefit from treatment with Navicixizumab. The Xerna™ TME panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the dominant biology of their cancer so that patients can be matched with therapies that directly address these biologies. Pursuant to the non-exclusive license, which is for research use only (“RUO”) and clinical development programs, OncXerna has granted QIAGEN the rights to integrate the Xerna™ TME panel into their NGS workflow solutions, which broadens QIAGEN’s NGS CDx custom panel development capabilities. “We are very pleased to complete these agreements with QIAGEN, which we see as providing important external validation for the Xerna™ TME panel and our broader RNA-based biomarker platform,” stated Dr. Laura Benjamin, OncXerna Founder and CEO. “As an NGS industry-leader in precision medicine diagnostics with impressive global development, manufacturing and commercial capabilities, we believe QIAGEN is uniquely positioned to help advance the Xerna™ TME panel towards regulatory approval as an NGS companion diagnostic and, if approved, drive the panel’s adoption. Moreover, integration of the Xerna™ TME Panel into their workflow solutions could enable QIAGEN to provide a new RNA-based offering to strengthen their overall immune oncology solutions for biopharma customers.” “We believe that the Xerna™ TME panel that we can now offer our customers will further enhance our strong portfolio in companion diagnostics. Through this agreement, we aim to foster additional NGS-based collaborations with pharmaceutical companies for the development of drug treatments for immune oncology and promote early clinical adoption of precision medicine diagnostics such as our therascreen portfolio and the Xerna™ TME panel,” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. “We are also thrilled to have the master CDx agreement in place and look forward to working with OncXerna to develop an NGS companion diagnostic for Navicixizumab based on our extensive track record with the development of companion diagnostics for a variety of cancers.” QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. QIAGEN has ten PCR based companion diagnostic indications that are FDA approved, including therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer. Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients. About OncXerna Therapeutics, its Xerna™ RNA-based Biomarker Platform, and Xerna™ TME Panel OncXerna is a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates. OncXerna is working to expand 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. OncXerna’s approach pairs those patients with OncXerna’s clinical-stage therapeutic candidates and known mechanism of action that directly address these biologies, with the goal to substantially 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 tumor microenvironment (TME), and has been developed as a clinical assay. 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 Navicixizumab 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 received at least three prior therapies and/or prior treatment with Avastin®. 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 QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2021, QIAGEN employed approximately 5,900 people in over 35 locations worldwide. Further information can be found at Forward-Looking Statement Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. 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For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission. Source: QIAGEN N.V. Category: Corporate