Across cancer types, immune checkpoint inhibitors have been shown to induce complete response, partial response, and stable disease after initial evidence of radiographic increase in tumor burden. Treatment beyond progression should be considered when the patient is stable (or improving) symptomatically and if tumor reassessment can be performed within a short period.

Start Date04 Nov 2022

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

[+1]

NCT04150900

/ Active, not recruitingPhase 2IIT

1922GCCC: PHASE 2 STUDY OF PEMBROLIZUMAB AND BAVITUXIMAB FOR PROGRESSIVE RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

This phase II single arm study is being done to determine if bavituximab could potentially synergize with PD-1 inhibitor therapy to generate an effective anti-tumor immune response in patients with recurrent/metastatic squamous cell head and neck cancer (HNSCC) who progressed on a PD-1 inhibitor.

Start Date13 Jan 2020

Sponsor / Collaborator

University of Maryland Baltimore

NCT03519997

/ CompletedPhase 2IIT

A Phase II Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

This is a non-randomized, open-label, multi-site phase II therapeutic trial of pembrolizumab and bavituximab in patients with locally advanced HCC. Locally advanced or metastatic HCC is defined as disease that is not amenable to surgical and/or locoregional therapies. Subjects must not have received prior systemic therapy for advanced HCC in keeping with the first-line setting of this study.

Start Date26 Apr 2018

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

[+1]

100 Clinical Results associated with Bavituximab

100 Translational Medicine associated with Bavituximab

100 Patents (Medical) associated with Bavituximab

Literatures (Medical) associated with Bavituximab

01 Sep 2024·JOURNAL OF BIOLOGICAL CHEMISTRY

Development of betabodies: The next generation of phosphatidylserine targeting agents

Article

Author: Huang, Xianming ; Brekken, Rolf A ; Phinney, Natalie Z ; Toombs, Jason E

Externalized phosphatidylserine (PS) is a phospholipid and a selective marker of the tumor microenvironment (TME). It is exposed on the outer leaflet of the plasma membrane of tumor-associated endothelial cells, apoptotic tumor cells, and some viable tumor cells, where it functions in part to suppress immune responses by binding to PS receptors expressed on tumor-infiltrating myeloid cells. PS has been targeted with antibodies, such as bavituximab, that bind the phospholipid via a cofactor, β2-glycoprotein 1 (β2GP1); these antibodies showed excellent specificity for tumor vasculature and induce an immune stimulatory environment. We have advanced this concept by developing the next generation of PS targeting agent, a fusion protein (betabody) constructed by linking PS-binding domain V of β2GP1 to the Fc of an IgG2a. Betabodies bind to externalized PS with high affinity (∼1 nM), without the requirement of a co-factor and localize robustly to the TME. We demonstrate that betabodies are a direct PS-targeting agent that has the potential to be used as anti-tumor therapy, drug delivery vehicles, and tools for imaging the TME.

15 Aug 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Bavituximab Decreases Immunosuppressive Myeloid-Derived Suppressor Cells in Newly Diagnosed Glioblastoma Patients

Article

Author: Brown, James M. ; Reardon, David A. ; Gerstner, Elizabeth R. ; Richardson, Leland G. ; Kalpathy-Cramer, Jayashree ; Giobbie-Hurder, Anita ; Batchelor, Tracy T. ; Curry, William T. ; Chang, Ken ; Muzikansky, Alona ; Lou, Kevin ; Cardona, Jonathan ; Chukwueke, Ugonma ; Jordan, Justin T. ; Lee, Eudocia Q. ; Liu, Mofei ; Choi, Bryan D. ; Ly, K. Ina ; Dietrich, Jorg ; Wen, Patrick Y. ; Arrillaga-Romany, Isabel C. ; Nayak, Lakshmi ; Ma, Xiaoyue ; Forst, Deborah A. ; Beers, Andrew L.

Abstract:

Purpose::

We evaluated the efficacy of bavituximab—a mAb with anti-angiogenic and immunomodulatory properties—in newly diagnosed patients with glioblastoma (GBM) who also received radiotherapy and temozolomide. Perfusion MRI and myeloid-related gene transcription and inflammatory infiltrates in pre-and post-treatment tumor specimens were studied to evaluate on-target effects (NCT03139916).

Patients and Methods::

Thirty-three adults with IDH--wild-type GBM received 6 weeks of concurrent chemoradiotherapy, followed by 6 cycles of temozolomide (C1-C6). Bavituximab was given weekly, starting week 1 of chemoradiotherapy, for at least 18 weeks. The primary endpoint was proportion of patients alive at 12 months (OS-12). The null hypothesis would be rejected if OS-12 was ≥72%. Relative cerebral blood flow (rCBF) and vascular permeability (Ktrans) were calculated from perfusion MRIs. Peripheral blood mononuclear cells and tumor tissue were analyzed pre-treatment and at disease progression using RNA transcriptomics and multispectral immunofluorescence for myeloid-derived suppressor cells (MDSC) and macrophages.

Results::

The study met its primary endpoint with an OS-12 of 73% (95% confidence interval, 59%–90%). Decreased pre-C1 rCBF (HR, 4.63; P = 0.029) and increased pre-C1 Ktrans were associated with improved overall survival (HR, 0.09; P = 0.005). Pre-treatment overexpression of myeloid-related genes in tumor tissue was associated with longer survival. Post-treatment tumor specimens contained fewer immunosuppressive MDSCs (P = 0.01).

Conclusions::

Bavituximab has activity in newly diagnosed GBM and resulted in on-target depletion of intratumoral immunosuppressive MDSCs. Elevated pre-treatment expression of myeloid-related transcripts in GBM may predict response to bavituximab.

01 Oct 2019·Targeted oncologyQ3 · MEDICINE

Efficacy and Safety of Bavituximab in Combination with Sorafenib in Advanced Hepatocellular Carcinoma: A Single-Arm, Open-Label, Phase II Clinical Trial

Q3 · MEDICINE

Article

Author: Beg, Muhammad S ; Yopp, Adam C ; Singal, Amit G ; Mokdad, Ali A ; Dowell, Jonathan E ; Zhu, Hao ; Arriaga, Yull

BACKGROUND:

Bavituximab, an immunomodulator, targets phosphatidylserine (PS), a membrane lipid externalized on tumor and endothelial cells in response to sorafenib.

OBJECTIVE:

The objective of this phase II study was to assess the efficacy of combination bavituximab and sorafenib in advanced hepatocellular carcinoma (HCC).

METHODS:

In this single-arm phase II study, patients with HCC determined to be unresectable with Eastern Cooperative Oncology Group (ECOG) score ≤ 2, Child-Pugh score A/B7 received intravenous bavituximab 3 mg/kg weekly and oral sorafenib 400 mg twice daily until disease progression or intolerable toxicity. We investigated time to progression (TTP) for patients receiving combination bavituximab and sorafenib compared with that for sorafenib-only historical controls.

RESULTS:

In total, 38 patients were accrued. The median follow-up was 6.1 months. Patient characteristics were as follows: median age 61 years; male 82%; hepatitis C virus 79%; Black 39%, Hispanic 26%, White 29%; previous treatment 39%; macrovascular invasion 84%; and extrahepatic metastases 24%. The median TTP was 6.7 months (95% confidence interval [CI] 4-17). The median overall survival was 6.1 months (95% CI 5-8), and the median disease-specific survival was 8.6 months (95% CI 6-14). Two patients experienced partial responses; none had a complete response. The disease control rate was 58%. Treatment-related adverse events were observed in 63% of patients, with the most commonly reported therapy-related symptoms being diarrhea (32%), fatigue (26%), and anorexia (24%).

CONCLUSIONS:

The efficacy of adding bavituximab to sorafenib for the treatment of advanced HCC was inconclusive; however, the combination regimen did not exacerbate toxicities associated with single-agent sorafenib. CLINICALTRIALS.

GOV IDENTIFIER:

NCT01264705.

News (Medical) associated with Bavituximab

23 Jan 2023

·www.biospace.com

OncXerna Therapeutics Announces Final Results and New Xerna™ TME Panel Biomarker Data from a Phase 2 Trial of Bavituximab Plus Pembrolizumab in Patients with Previously Untreated Advanced Hepatocellular Carcinoma

Bavituximab plus pembrolizumab combination achieved a 62.5% response rate in biomarker positive subgroup of hepatocellular cancer patients Data reinforce the potential of Xerna TME Panel to substantially improve outcomes for patients WALTHAM, Mass., Jan. 23, 2023 (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, announced final results from a Phase 2 trial of bavituximab plus pembrolizumab in patients with previously untreated advanced hepatocellular carcinoma and new biomarker data demonstrating that the Xerna™ TME Panel clearly identified trial participants more likely to benefit from treatment. The data were featured in a poster that was presented on January 20, 2023 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The biomarker results presented at ASCO GI are from a planned analysis of tumor biopsies using the Xerna TME Panel, a novel RNA expression-based diagnostic panel that uses a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). In the study featured in the ASCO GI poster, pre-treatment tumor biopsies were analyzed using the Xerna TME Panel and findings were correlated with objective tumor response to test the hypothesis that tumors with high immune scores (immune active or immune-suppressed TME subtypes [biomarker-positive]) are more likely to respond to bavituximab plus pembrolizumab than those with low immune scores (angiogenic or immune-desert TME subtypes [biomarker-negative]). David Hsieh, M.D., Assistant Professor at University of Texas Southwestern Medical Center and lead investigator of the Phase 2 trial, commented, “Our newly reported clinical data in front-line liver cancer show a near doubling of response rate in the subset of patients classified as biomarker-positive by the Xerna TME Panel. The high response rate seen in these patients is rarely achieved in this challenging disease. Moreover, our patients are potentially more reflective of typical U.S.-based patients compared to those included in recent large, pivotal trials that enrolled the majority of their patients at sites outside of the U.S. We are therefore excited by the prospect of using this panel to optimize the care of patients with liver cancer.” Key data featured in the ASCO GI poster are summarized below. BestOverallResponse N (%) AllPatients1 N=28 PatientswithBiomarkerData2 All N=19 Biomarker+ N=8 Biomarker- N=11 Complete response3 2 (7.1) 1 (5.3) 1 (12.5) 0 (0) Partial response3 7 (25.0) 5 (26.3) 4 (50.0) 1 (9.1) Stable disease 5 (17.9) 3 (15.8) 1 (12.5) 2 (18.2) Progressive disease 14 (50.0) 10 (52.6) 2 (25.0) 8 (72.7) Objective response rate 9 (32.1) 6 (31.6) 5 (62.5) 1 (9.1) Disease control rate 14 (50.0) 9 (47.4) 6 (75.0) 3 (27.3) 1Analysis based on evaluable patients per protocol.2All patients with available biomarker results; 9patientsdidnot have tissueavailablefor testingandbiomarkerstatuscouldnot be determined.3Responses were confirmed by radiographic assessment no sooner than 4 weeks from the time ofinitial response. Hagop Youssoufian, M.D., Chief Medical Officer of OncXerna Therapeutics and Adjunct Professor of Medicine at Brown University, commented, “The Xerna TME Panel has demonstrated remarkable consistency in identifying patients who are more likely to benefit from targeted and immune therapies across several malignancies. Although this was a proof-of-concept study, the responses noted in the biomarker-positive subgroup of patients in this lethal disease indicate substantial activity by comparison to the most active and contemporary combination therapies. This is the latest example of OncXerna’s longstanding commitment to utilize the Xerna TME Panel to bring the right medicines to the right patients.” A copy of the ASCO GI poster, entitled: “A phase II clinical trial of the phosphatidylserine targeting antibody, bavituximab in combination with pembrolizumab in patients with advanced hepatocellular carcinoma,” will be available on the OncXerna website following the conclusion of the ASCO GI Symposium. About the Phase 2 Trial The trial featured in the ASCO GI poster was an investigator-sponsored, Phase 2, single arm study conducted at the University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center. The trial evaluated the combination of bavituximab and pembrolizumab in previously untreated patients with advanced hepatocellular carcinoma (HCC). The primary objective of the study was to determine the overall response rate (ORR) of the studied combination in patients with advanced HCC. Results showed bavituximab plus pembrolizumab was well tolerated, with no new safety signals, and that the studied combination induced objective tumor response in a meaningful subset of trial participants. Analysis of tumor biopsies showed that the response rate was enhanced in Xerna TME biomarker positive patients, while higher progressive disease rates were observed in biomarker negative patients. For more information on the trial, see Clinicaltrials.gov Identifier: NCT03519997. About Bavituximab Bavituximab is an antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling and is currently in Phase 2 clinical trials. 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). This biology is relevant across multiple types of solid tumors. Bavituximab 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 gastric 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 (PS) 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

Clinical ResultPhase 2ASCOImmunotherapy

12 Sep 2022

·www.globenewswire.com

OncXerna Therapeutics Announces New Xerna™ TME Panel Biomarker Data from Retrospective Analysis of Results from a Randomized Phase 2 Trial Evaluating Anti-PD-1 Maintenance Therapy in Esophagogastric Adenocarcinoma at the ESMO Congress 2022

Better 24-month survival was achieved when durvalumab was used for maintenance compared to surveillance in esophagogastric adenocarcinoma patients with “high” Xerna TME Panel immune scores, despite these patients having a poorer prognosis Data suggest the Xerna TME Panel can predict which HER2- esophagogastric adenocarcinoma patients will benefit from checkpoint inhibitors more accurately than PD-L1 combined positive scores WALTHAM, Mass., Sept. 12, 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 new biomarker data suggesting the Xerna TME Panel has predictive and prognostic potential in esophagogastric adenocarcinoma. The data are featured in a poster being presented today at the European Society for Medical Oncology (ESMO) Congress 2022. The data featured in the ESMO poster are from retrospective analyses of results from PLATFORM, a randomized Phase 2 trial that evaluated maintenance therapies such as the anti-PD-1 antibody durvalumab in esophagogastric adenocarcinoma patients treated with first-line chemotherapy. Analyses were performed using the Xerna TME Panel, a novel RNA gene expression-based diagnostic panel that uses a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). Using the Xerna TME Panel, researchers analyzed pre-treatment tumor biopsies to classify patients who went on to receive durvalumab maintenance therapy or active surveillance only as immune score “high” or immune score “low.” These classifications were compared against clinical outcomes recorded in the trial. Results showed that immune score high patients had a poorer prognosis with active surveillance compared to immune score low patients. However, despite this poorer prognosis, immune score high patients had improved 6- and 12-month progression free survival and 24-month overall survival with durvalumab maintenance therapy compared to the immune score high patients that received active surveillance. Analyses in the poster also compared the predictive potential of Xerna TME Panel classifications in esophagogastric adenocarcinoma to that of classifications based on PD-L1 combined positive score (CPS) status. “Though specifically tailoring therapeutic regimens for individual patients can be an effective technique in the treatment of GI cancers, its application is limited by a lack of predictive biomarkers,” said Professor Ian Chau, M.D., FRCP, co-author on the poster and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Professor at the Institute of Cancer Research, London & Surrey. “Data being presented at ESMO suggest the Xerna TME Panel can expand the applicability of personalized medicine in esophagogastric adenocarcinoma by predicting the patients who may benefit from anti-PD-1 maintenance therapy more accurately than PD-L1 CPS status. Moreover, classifications incorporating both PD-L1 CPS status and the Xerna TME Panel appear to further distinguish the subset of patients that will derive the most durable clinical benefit from checkpoint inhibitors. Taken together, these encouraging findings support the Xerna TME Panel’s potential as a diagnostic that can help us understand which patients are more likely to benefit from treatment and those that will not. This will hopefully lead to better treatment decisions and improved clinical outcomes for patients.” Key data featured in the ESMO poster are summarized in Tables 1A (patients randomized to active surveillance) and 1B (patients randomized to durvalumab maintenance therapy) below. Table 1A: Survival function estimates for patients enrolled in the active surveillance arm according to Xerna TME Panel and PD-L1 CPS status. Data presented as: rate (97.5% confidence interval)PFS: Progression-free survival; OS: Overall survival Xerna TME Panel Immune Score ClassificationPD-L1 CPS Status High (n=20)Low (n=18)CPS ≥5 (n=19)CPS <5 (n=18)6-month PFS Rate17.5%(3.5% – 40.4%)27.8%(8.3% – 51.8%)18.4%(3.7% – 42.1%)27.8%(8.3% – 51.8%)12-month PFS Rate0%(CI not determined)5.6%(0.2% – 25.7%)0%(CI not determined)5.6%(0.2% – 25.7%)12-month OS Rate46.7%(20.3% – 69.5%)42.1%(16.4% – 66.1%)32.2%(10.1% – 57.1%)59.3%(29.1% – 80.1%)24-month OS Rate8.8%(0.4% – 33.8%)24.1%(6.0% – 48.7%)8.6%(0.3% – 34.6%)23.7%(5.9% – 48.2%) Table 1B: Survival function estimates for patients enrolled in the durvalumab arm according to Xerna TME Panel and PD-L1 CPS status. Data presented as: rate (97.5% confidence interval) Xerna TME Panel Immune Score ClassificationPD-L1 CPS Status High (n=22)Low (n=22)CPS ≥5 (n=26)CPS <5 (n=17)6-month PFS Rate35.0% (13.4% – 57.8%)27.3% (9.4% – 49.0%)28.0% (10.7% – 48.5%)31.3% (9.3% – 56.6%)12-month PFS Rate25.0%(7.5% – 47.7%)4.6% (0.2% – 21.8%)16.0% (4.0% – 35.1%)12.5% (1.4% – 36.1%)12-month OS Rate40.0% (16.7% – 62.6%)40.1% (18.3% – 62.5%)40.0% (18.9% – 60.5%)37.5% (12.9% – 62.6%)24-month OS Rate35.0% (13.4% – 57.8%)22.7% (6.8% – 44.2%)24.0% (8.2% – 44.2%)31.3% (9.3% – 56.6%) Additionally, in PD-L1 CPS ≥5 patients who received durvalumab, 24-month OS rates were 38% and 0% in Xerna TME Panel immune score high (n=17) and low (n=9) subgroups, respectively. Twelve-month OS rates in the same subgroups were 44% and 33%, respectively. Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics and co-author on the ESMO poster, commented, “These results add to an emerging dataset suggesting the Xerna TME Panel can improve the probability of success in clinical trials of not only our internally developed product candidates, navicixizumab and bavituximab, but in trials of a wide range of precision therapies. We are fortunate to be collaborating with leading experts from industry and academia on these efforts, including my co-authors from QIAGEN GmbH, Genialis, and The Royal Marsden. I look forward to continuing our work together as we strive to leverage the XERNA TME Panel to increase the number of cancer patients that can benefit from a precision medicine approach.” A copy of the ESMO poster, entitled: “Predicting benefit from maintenance durvalumab after first-line chemotherapy (1L CTx) in oesophagogastric adenocarcinoma (OGA) using a novel tumour microenvironment (TME) RNA assay,” will be available on the OncXerna website following the conclusion of the ESMO Congress. About PLATFORM PLATFORM was a Phase 2, randomized, multicenter, adaptive study sponsored by The Royal Marsden NHS Foundation Trust that assessed various maintenance therapies in locally advanced or metastatic esophagogastric adenocarcinoma patients. Patients initially received standard chemotherapy according to local practice based upon their HER2 status. HER2-negative patients who completed at least six cycles of standard chemotherapy, achieved stable disease or better on the end-of-treatment CT scan, and met additional eligibility criteria were then randomized to receive active surveillance only or a selected maintenance therapy, one of which was durvalumab. Results showed durvalumab maintenance therapy did not prolong PFS or OS compared to active surveillance in HER2-negative patients unselected for PD-L1 status. For more information on the trial, see Clinicaltrials.gov Identifier: NCT02678182. 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. RobinsonLifeSci Partners, LLCarr@lifesciadvisors.com

CollaborateAntibody

08 Sep 2022

·www.biospace.com

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 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

CollaborateAntibodyFast Track

100 Deals associated with Bavituximab

External Link

KEGG	Wiki	ATC	Drug Bank
D06561	Bavituximab	-	DB05136

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic breast cancer	Phase 3	United States	Avid Bioservices, Inc.	01 Dec 2015
metastatic non-small cell lung cancer	Phase 3	United States	Avid Bioservices, Inc.	01 Dec 2013
metastatic non-small cell lung cancer	Phase 3	Australia	Avid Bioservices, Inc.	01 Dec 2013
metastatic non-small cell lung cancer	Phase 3	Belgium	Avid Bioservices, Inc.	01 Dec 2013
metastatic non-small cell lung cancer	Phase 3	France	Avid Bioservices, Inc.	01 Dec 2013
metastatic non-small cell lung cancer	Phase 3	Germany	Avid Bioservices, Inc.	01 Dec 2013
metastatic non-small cell lung cancer	Phase 3	Greece	Avid Bioservices, Inc.	01 Dec 2013
metastatic non-small cell lung cancer	Phase 3	Hungary	Avid Bioservices, Inc.	01 Dec 2013
metastatic non-small cell lung cancer	Phase 3	Italy	Avid Bioservices, Inc.	01 Dec 2013
metastatic non-small cell lung cancer	Phase 3	Romania	Avid Bioservices, Inc.	01 Dec 2013

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04150900 (CTgov)	Phase 2	Squamous cell carcinoma of head and neck metastatic	7	Bavituximab+Pembrolizumab	dhtcvsstrj = tsefrqbtep zhfqbdorrq (fwujuarxvc, rrhssjlovo - lcwspbtcac) View more	-	28 Feb 2025
NCT03519997 (CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	35	Bavituximab+Pembrolizumab	snjbfiavda = evtahpxzgb mfvatlwavo (bqenglnscx, rybaujcpgh - wqtwyppuin) View more	-	17 Jul 2024
NCT03139916 (CTgov)	Phase 2	Glioblastoma Multiforme \| Glioblastoma	36	Radiation+Temozolomide+Bavituximab	qrhxujqaxp = ynhqbbzzck cvhodseccs (ydbleshtkl, bepdbbinea - poxnqlncpp) View more	-	16 May 2024
NCT03139916 (Pubmed \| Clin Cancer Res)	Phase 2	Glioblastoma	36	Bavituximab	mzajazxsxk(aanjddxwrs) = eevfxsacga ddllarkvjm (wqiudfilua, 59 - 90)	-	16 Jun 2023
NCT04099641 (ONCG100, ASCO2023) Manual	Phase 2	Advanced gastric carcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma Second line	80	Bavituximab 3 mg/kg + Pembrolizumab 200 mg (Grp 1)	amltunvgsx(epkeghgkch) = The most frequently reported Grade ≥ 3 treatment emergent adverse events (occurring in ≥10% of patients overall) were anaemia and gastric cancer progression (n= 10/AE). ekeabqtlrz (cbwyqmwpss )	Positive	31 May 2023
NCT04099641 (ONCG100, ASCO2023) Manual	Phase 2		80	Bavituximab 3 mg/kg + Pembrolizumab 200 mg (Grp 2)		Positive	31 May 2023
NCT04099641 (ONCG100, CTgov)	Phase 2	Advanced gastric carcinoma \| Gastrooesophageal junction cancer \| Malignant neoplasm of gastro-oesophageal junction	80	CPI (Group 1 (CPI Naïve))	qwhxsfeqgv = tezluksqfy xrfmpjdjaf (pyzbwqvczr, svarkjrnbj - gvyrkagknu) View more	-	08 Feb 2023
NCT04099641 (ONCG100, CTgov)	Phase 2		80	bavituximab+pembrolizumab (Group 2 (CPI Relapse))	qwhxsfeqgv = pgflelovcg xrfmpjdjaf (pyzbwqvczr, xkwtaosdbz - lpxvoqorpy) View more	-	08 Feb 2023
NCT03519997 (ASCO_GI2023) Manual	Phase 2	Advanced Hepatocellular Carcinoma	28	Pembrolizumab 200 mg+Bavituximab 3 mg/kg	vnjxrynewl(nkppiajrdf) = ntgzgiibxp xqnzajosqe (bxswxjqgmu ) View more	Positive	24 Jan 2023
NCT03139916 (ASCO2022) Manual	Phase 2	Glioblastoma First line	33	chemoradiation+temozolomide+bavituximab	ncmxoquozs(rhszsowciu) = leesflxgki oiqprnuusn (hcyezkdteh, 59 - 90) View more	Positive	02 Jun 2022
NCT04099641 (ESMO2021) Manual	Phase 2	Gastrooesophageal junction cancer \| Stomach Cancer Second line	61	bavituximab+pembrolizumab (CPI naïve patients)	hbxepvwdjd(pibqpygbcc) = Anemia (14%), ascites and increased aspartate aminotransferase (6%). jnebtkqbzf (drcifriwhy ) View more	Positive	16 Sep 2021
NCT04099641 (ESMO2021) Manual	Phase 2		61	bavituximab+pembrolizumab (XernaTMTME Panel)		Positive	16 Sep 2021
NCT01264705 (CTgov)	Phase 1/2	Advanced Hepatocellular Carcinoma	47	bavituximab+sorafenib (Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily)	qcqstghkqf = zmltznsbfw txjamkneay (kzackqvyrc, yidkbueeju - wkqqyaynez)	-	12 Nov 2020
NCT01264705 (CTgov)	Phase 1/2	Advanced Hepatocellular Carcinoma	47	bavituximab+sorafenib (Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily)	qcqstghkqf = vnrrverfxt txjamkneay (kzackqvyrc, vqwxltbsev - odragurtis)	-	12 Nov 2020

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