Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 171 |
| INN | Bavituximab |
| Status | Terminated |
| Drug code(s) | 3G4 |
| Brand name | Tarvacin |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Phosphatidylserine |
| Indications of clinical studies | Liver Cancer, Pancreatic Cancer, breast cancer, solid tumors, Non-small-cell Lung Cancer, hepatitis C, |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | June 15, 2005 |
| Start of Phase 2 | January 15, 2008 |
| Start of Phase 3 | December 29, 2013 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | OncXerna Therapeutics Inc. |
| Licensee/Partner | Avid Bioservices Inc. |
| Comments about company or candidate | Apr 2024: No company-sponsored studies are active; OncXerna Therapeutics website not found. Mar 2023: Listed as Phase 2 asset in OncXerna Therapeutics pipeline accessed Mar 27, 2023. January 23, 2023, OncXerna Therapeutics, Inc., 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 (NCT03519997) 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. September 18, 2020 – Oncologie, Inc., a precision medicine company using an innovative RNA-based biomarker platform to predict patient responses for potentially first-in-class targeted oncology therapies, today announced new data and analyses from its lead clinical programs, bavituximab and navicixizumab. On the basis of these positive data, the company also announced its rebranding to OncXerna Therapeutics, Inc., a change that reinforces the company’s focus on using its RNA-based approach to guide novel, targeted treatments to specific people with cancer. Study data are being presented at the European Society for Molecular Oncology (ESMO) Virtual Congress 2020 taking place September 19-21, 2020. OncXerna plans to conduct additional clinical trials designed to prospectively enrich for TME Panel-1 biomarker positive patients, as well as to explore additional solid tumor types. Oct 2019: Oncologie announced the enrollment of the first patient in its global Phase 2 study of bavituximab in combination with Merck’s (known outside of the U.S. as MSD), anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer. Sep 11, 2019: NCT04099641 Phase 2, Multicenter Open-label, Non-randomized Study of Bavituximab Plus Pembrolizumab in Patients With Advanced Gastric or Gastroesophageal Cancer Who Have Progressed on or After at Least One Prior Standard Therapy started. August 2019: Oncologie announced that it has entered into a clinical collaboration agreement with Merck to evaluate the combination of Oncologie’s investigational drug Bavituximab, an antibody that blocks the activity of phosphatidylserine (PS), and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer. Under the terms of the agreement, Oncologie will conduct a Phase II single arm open-label study to determine the efficacy and safety of Bavituximab in combination with KEYTRUDA in patients who have advanced gastric and gastroesophageal cancer, after they have failed at least one line of treatment. The study is expected to enroll approximately 80 patients in the U.S., United Kingdom, Korea and Taiwan. The study is anticipated to start enrollment in the second half of 2019.June 2019: Oncologie will initiate key clinical trials in the coming months, including a global proof of concept gastric cancer study with its lead compound, bavituximab, in combination with pembrolizumab (Keytruda). In February 2018, Avid Bioservices and Oncologie announced that the companies have entered into an Asset Assignment and Purchase Agreement for Avid’s phosphatidylserine (PS)-targeting program including bavituximab. In addition to bavituximab, the deal includes Avid’s other PS-targeting antibodies, including betabodies, as well as certain other assets and licenses useful and/or necessary for the potential commercialization of bavituximab. Feb 1, 2018: Avid BioServices (formerly Peregrine Pharmaceuticals) has discontinued all R&D activity for bavituximab. There is no intent to reinitiate such activities in the future. Rather, the company is committed to being a dedicated CDMO. Peregrine announced that it is changing its name to Avid Bioservices, Inc. as part of its transition to a dedicated contract development and manufacturing organization (CDMO). In addition to the name change, the company is also adopting the new NASDAQ ticker symbol "CDMO" (NASDAQ:CDMO). The name and ticker symbol changes will both be effective as of market open on Monday, January 8, 2018. Phase II study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins planned. March 2017: Peregrine's clinical development strategy for bavituximab currently focuses on small, early-stage, proof-of-concept trials evaluating the drug in combination with other cancer treatments. As part of this approach the National Comprehensive Cancer Network (NCCN) has awarded grants to support three different clinical trials of bavituximab treatment combinations. These trials will evaluate novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination. Sep 2016: Peregrine's clinical development strategy for bavituximab is currently focused on small, early-stage proof-of-concept trials evaluating the drug in combination with other cancer treatments. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program. March 2016: Phase 2/3 study in breast cancer suspended. Feb 2016: Company discontinued the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The decision to stop the trial was based on the recommendation of the study's Independent Data Monitoring Committee (IDMC) following a pre-specified interim analysis performed after 33% of targeted overall events (patient deaths) in the study were reached. Results of the analysis demonstrated that the bavituximab plus docetaxel group did not show a sufficient improvement in overall survival as compared to the docetaxel group to warrant continuation of the study. Phase 2/3 NCT02651610 in HER2-neg breast cancer started in Dec 2015. AstraZeneca will collaborate with Peregrine Pharmaceuticals in a Phase I/Ib study to evaluate the combination of AstraZeneca's durvalumab and Peregrine's bavituximab, along with chemotherapy, as a treatment for multiple solid tumors. As of July 2013, the company reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase III registration trial design of bavituximab in second-line non-small cell lung cancer (NSCLC). NCT01999673 Phase 3 SUNRISE study started in Dec 2013. Fast track designation for NSCLC indication recd in Jan 2014 |
| Full address of company | Waltham, Massachusetts North America United States of America https://www.linkedin.com/company/oncxernatherapeutics |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |