Tarvacin (bavituximab) / OncXerna Therap 
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 58 Diseases   2 Trials   2 Trials   158 News 


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  • ||||||||||  Tarvacin (bavituximab) / OncXerna Therap
    Journal:  Phosphatidylserine (PS)-targeting chimeric Interferon (IFN) fusion proteins for anti-tumor applications. (Pubmed Central) -  Feb 3, 2025   
    retain strong anti-tumor activities in a syngeneic model when expressed ectopically in a E0771 breast cancer model and B16-F10 melanoma models. Collectively, we report on the generation and utility of a series of novel in class IFN fusion proteins that target the immune stimulatory features of IFNs to the PS externalization in the tumor microenvironment.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    P2 data, Clinical Trial,Phase II, Journal, PD(L)-1 Biomarker, IO biomarker:  The phosphatidylserine targeting antibody bavituximab plus pembrolizumab in unresectable hepatocellular carcinoma: a phase 2 trial. (Pubmed Central) -  Mar 16, 2024   
    P2
    Prespecified exploratory analyses of baseline tumor specimens showed that a depletion of B cells, and the presence of fibrotic tissue and expression of immune checkpoints in stroma was associated with tumor response. These results suggest that targeting phosphatidylserine may lead to synergistic effects with PD-1 blockade without increasing toxicity rates, and future studies on this therapeutic strategy may be guided by biomarkers characterizing the pre-treatment tumor microenvironment.
  • ||||||||||  Tarvacin (bavituximab) / OncXerna Therap
    Trial completion:  Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) -  Oct 23, 2023   
    P2,  N=36, Completed, 
    Prior tx with docetaxel or immune checkpoint inhibitors was a common exclusion criterion...All IOs demonstrated significant improvement in OS vs CTs, except bavituximab and avelumab...One study comparing IO Active, not recruiting --> Completed
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Enrollment closed, Enrollment change, Metastases:  1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck (clinicaltrials.gov) -  Sep 5, 2023   
    P2,  N=7, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=29 --> 7
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Trial completion date, Trial primary completion date, Metastases:  A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  May 1, 2023   
    P2,  N=28, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2023 --> Apr 2024
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Trial completion date, Trial primary completion date, Metastases:  1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck (clinicaltrials.gov) -  Mar 22, 2023   
    P2,  N=29, Recruiting, 
    Higher ORRs were observed in CPI-na Trial completion date: Jan 2025 --> Jan 2027 | Trial primary completion date: Jan 2023 --> Jan 2025
  • ||||||||||  Tarvacin (bavituximab) / OncXerna Therap
    Aberrantly exposed phosphatidylserine as a drug delivery target in pancreatic cancer (Section 3; Poster Board #23) -  Mar 14, 2023 - Abstract #AACR2023AACR_4358;    
    To this point, PS has been targeted with antibodies, such as Bavituximab, that have shown excellent specificity for tumor vasculature and an immune stimulatory environment evidence by polarization of macrophages to a pro-inflammatory M1-like phenotype, a reduction in myeloid-derived suppressor cells, enhanced maturation of dendritic cells and increased primed T cell activity...The mechanism of action has not yet been fully elucidated; however, it may involve the interaction between the ?2GP1 domains and endogenous LPS. This first-in-class tumor targeting therapeutic has potential to provide efficacy in therapy-resistant pancreatic tumors via targeted drug delivery as well as modulation of the immuno-microenvironment like its PS targeting predecessors.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Trial completion, Metastases:  KEYNOTE 978: An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients (clinicaltrials.gov) -  Feb 8, 2023   
    P2,  N=80, Completed, 
    These studies revealed 1) distinct differences in cleavage rates for drug-linkers, 2) cleavage by cathepsin L, and 3) efficient cathepsin B mediated release of payload from the ADC. Active, not recruiting --> Completed
  • ||||||||||  Inlyta (axitinib) / Pfizer, Bavencio (avelumab) / EMD Serono, Tarvacin (bavituximab) / OncXerna Therap
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  Feb 6, 2023   
    P2,  N=1, Terminated, 
    Active, not recruiting --> Completed N=29 --> 1 | Trial completion date: Mar 2028 --> Dec 2022 | Recruiting --> Terminated | Trial primary completion date: Mar 2026 --> Dec 2022; Sponsor pulled support for one of the study drugs.
  • ||||||||||  Inlyta (axitinib) / Pfizer, Bavencio (avelumab) / EMD Serono, Tarvacin (bavituximab) / OncXerna Therap
    Enrollment open, Metastases:  Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  Nov 14, 2022   
    P2,  N=29, Recruiting, 
    Clinical trial information: NCT03519997. Not yet recruiting --> Recruiting
  • ||||||||||  Inlyta (axitinib) / Pfizer, Bavencio (avelumab) / EMD Serono, Tarvacin (bavituximab) / OncXerna Therap
    Trial initiation date, Metastases:  Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  Oct 4, 2022   
    P2,  N=29, Not yet recruiting, 
    Not yet recruiting --> Recruiting Initiation date: Sep 2022 --> Dec 2022
  • ||||||||||  Inlyta (axitinib) / Pfizer, Bavencio (avelumab) / EMD Serono, Tarvacin (bavituximab) / OncXerna Therap
    Trial initiation date, Metastases:  Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  Jun 28, 2022   
    P2,  N=29, Not yet recruiting, 
    Initiation date: Sep 2022 --> Dec 2022 Initiation date: Jun 2022 --> Sep 2022
  • ||||||||||  Tarvacin (bavituximab) / OncXerna Therap, BXQ-350 / Bexion
    Biomarker, Review, Journal:  Phosphatidylserine: The Unique Dual-Role Biomarker for Cancer Imaging and Therapy. (Pubmed Central) -  May 30, 2022   
    Recent studies have demonstrated that upregulation of surface PS exposure by chemodrugs, radiation, and external electric fields can be used as a novel approach to sensitize cancer cells to PS-targeting anticancer drugs. The objectives of this review are to provide an overview of a unique dual-role of PS as a biomarker/target for cancer imaging and therapy, and to discuss PS-based anticancer strategies that are currently under active development.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Trial completion date, Trial primary completion date, Metastases:  A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  May 4, 2022   
    P2,  N=28, Recruiting, 
    No abstract available Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Apr 2022 --> Apr 2023
  • ||||||||||  Tarvacin (bavituximab) / OncXerna Therap
    Trial completion date, Trial primary completion date:  Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) -  Oct 29, 2021   
    P2,  N=36, Active, not recruiting, 
    As expected, based on the mechanism of action of BAV, there was no difference in PBMC gene expression profile in patients with long and short survival. Trial completion date: Oct 2021 --> Aug 2022 | Trial primary completion date: Oct 2021 --> Aug 2022
  • ||||||||||  Tarvacin (bavituximab) / OncXerna Therap
    Journal:  Phosphatidylserine-Targeting Monoclonal Antibodies Exhibit Distinct Biochemical and Cellular Effects on Anti-CD3/CD28-Stimulated T Cell IFN-γ and TNF-α Production. (Pubmed Central) -  Oct 27, 2021   
    Using human T cells from healthy donor PBMCs activated with an anti-CD3 + anti-CD28 Ab mixture (anti-CD3/CD28) as a model for TCR-mediated PS externalization and T cell stimulation, we investigated effects of two different PS-targeting mAbs, 11.31 and bavituximab (Bavi), on TCR activation and TCR-mediated cytokine production in an ex vivo paradigm...Imaging showed 11.31 and Bavi bind at distinct focal depots on the cell membrane. Collectively, our findings indicate that PS-targeting mAb 11.31 suppresses cytokine production by anti-CD3/28 activated T cells.
  • ||||||||||  Tarvacin (bavituximab) / OncXerna Therap
    Review, Journal:  Targeting phosphatidylserine for Cancer therapy: prospects and challenges. (Pubmed Central) -  May 29, 2021   
    In addition, we discuss current drug developments that are based on PS-targeting strategies in both experimental and clinical studies. We hope to provide a future research direction for the development of new agents for cancer therapy.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Trial completion date, Trial primary completion date, Metastases:  A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  May 6, 2021   
    P2,  N=28, Recruiting, 
    We hope to provide a future research direction for the development of new agents for cancer therapy. Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Apr 2021 --> Apr 2022
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Trial primary completion date, Metastases:  KEYNOTE 978: An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients (clinicaltrials.gov) -  Feb 24, 2021   
    P2,  N=80, Recruiting, 
    Biological activity reflected by MDSC modulations in blood and TIL Increases in tumor biopsies with GB1275 alone and with pembrolizumab supports the mechanism of GB1275 . Trial primary completion date: Jan 2021 --> Oct 2021
  • ||||||||||  Retrospective data, Review, Journal:  Late-Stage Failures of Monoclonal Antibody Drugs: A Retrospective Case Study Analysis. (Pubmed Central) -  Oct 30, 2020   
    Trial primary completion date: Jan 2021 --> Oct 2021 By learning from previous mistakes and adhering to the principles and recommendations provided, it is possible to avoid these common pitfalls, increasing the likelihood of success in phase III clinical trials, and thus securing regulatory approval.
  • ||||||||||  Tarvacin (bavituximab) / OncXerna Therap
    Trial completion date, Trial primary completion date:  Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) -  Oct 13, 2020   
    P2,  N=36, Active, not recruiting, 
    By learning from previous mistakes and adhering to the principles and recommendations provided, it is possible to avoid these common pitfalls, increasing the likelihood of success in phase III clinical trials, and thus securing regulatory approval. Trial completion date: Jul 2020 --> Oct 2021 | Trial primary completion date: Jul 2020 --> Oct 2021
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Trial completion date, Trial primary completion date, Metastases:  A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  May 13, 2020   
    P2,  N=34, Recruiting, 
    Funding: Oncologie, Inc. Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Apr 2021
  • ||||||||||  Tarvacin (bavituximab) / Oncologie
    Phosphatidylserine targeting antibody enhances anti-tumor activity of adoptive cell therapies in a mouse melanoma model  (Board Number: P1331) -  Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_907;    
    Our lab has shown that the mouse chimeric version of PS Targeting monoclonal antibody Bavituximab (1N11), in combination with transgenic CD4+ T cells that recognize melanoma antigen Trp1, can regress advanced melanoma tumors in mice...These findings highlight that diminishing suppressive mechanisms locally with PS targeting can enhance the efficacy of transgenic TCR and CAR T cells to improve the outcome in patients with advanced-stage melanoma. Our studies may inform the design of clinical trials combining PS Targeting antibodies with CAR T cell therapy in solid tumors.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Tarvacin (bavituximab) / OncXerna Therap
    Enrollment open, Metastases:  1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck (clinicaltrials.gov) -  Jan 27, 2020   
    P2,  N=29, Recruiting, 
    Bavituximab induces changes in tumor vasculature that may improve survival in a subset of patients. Not yet recruiting --> Recruiting