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  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma, Avastin (bevacizumab) / Roche
    Review, Journal:  Narrative review of malignant ascites: epidemiology, pathophysiology, assessment, and treatment. (Pubmed Central) -  Apr 22, 2024   
    Despite these options, no standard treatment for MA has been established yet because few trials have been conducted in this area. There are many issues to be investigated, and future research and treatment development are expected.
  • ||||||||||  Journal:  A pivotal decade for bispecific antibodies? (Pubmed Central) -  Mar 15, 2024   
    Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.
  • ||||||||||  Mitigation of liver toxicity effects of bispecific T cell engagers in immune-competent liver-tumor co-culturing high-throughput platform (Section 29) -  Mar 5, 2024 - Abstract #AACR2024AACR_2578;    
    Additionally, we established a solid tumor model using human cancer cell lines (HCT116-GFP) and primary cancer-associated fibroblasts, effectively mimicking the complex tumor microenvironment We treated 3D spheroid models with runimotamab (HER2xCD3 BiTE), catumaxomab (EPCAMxCD3), nivatrotamab (GD2xCD3) and control bispecific antibodies in the presence of peripheral blood mononuclear cells (PBMCs)...To mitigate potential liver toxicity, we co-treated spheroid co-cultures with adalimumab (anti-TNF), tocilizumab (anti-IL-6R), raleukin (IL-1R antagonist) (each 100ug/ml), desatanib, dexamethasone or ruxolitinib (each 100nM)...In summary, we have developed a relevant, high-throughput platform for the evaluation of novel immunotherapies closely reflecting clinical scenarios. High throughput of the assay represents a powerful screening tool for clinical candidate development.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma
    Biomarker, Journal:  Using biomarkers to allocate patients in a response-adaptive clinical trial. (Pubmed Central) -  Dec 4, 2023   
    A completed clinical trial for the effect of catumaxomab on the survival of cancer patients is used as an example to demonstrate the use of the method and the differences to a controlled trial with equal allocation. Different regression procedures are investigated and compared to a randomized controlled trial, using efficacy and ethical measures.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma
    Review, Journal:  Immunotherapy for Peritoneal Carcinomatosis: Challenges and Prospective Outcomes. (Pubmed Central) -  May 16, 2023   
    Catumaxomab is a trifunctional antibody intraperitoneal (IP) immunotherapy authorized in Europe that can be used to diminish malignant ascites by targeting EpCAM...This reaction was strengthened by anti-PD-L1 or anti-Gr1. When paired with CD137 co-stimulatory signaling, CAR-T cells for folate receptor cancers made it easier for T-cell tumors to find their way to and stay alive in the body.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma
    Enrollment open, Trial primary completion date:  Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine (clinicaltrials.gov) -  Feb 13, 2023   
    P1/2,  N=161, Recruiting, 
    When paired with CD137 co-stimulatory signaling, CAR-T cells for folate receptor cancers made it easier for T-cell tumors to find their way to and stay alive in the body. Not yet recruiting --> Recruiting | Trial primary completion date: Nov 2023 --> Nov 2024
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma
    Journal:  Peritoneal carcinomatosis with intraperitoneal immunotherapy: current treatment options and perspectives. (Pubmed Central) -  Oct 27, 2022   
    This review elaborates on the knowledge of the peritoneal immune microenvironment and IP immunotherapy for PC covering immune stimulators, radioimmunotherapy, catumaxomab, cancer vaccines, chimeric antigen receptor (CAR)-T cells, and immune checkpoint inhibitors...However, the peritoneal cavity is a unique immune compartment with abundant immune cells which can produce effective immunity. IP immunotherapy may be a promising strategy in patients with PC.
  • ||||||||||  Journal:  Construction of miRNA-regulated drug-pathway network to screen drug repurposing candidates for multiple sclerosis. (Pubmed Central) -  Apr 7, 2022   
    We analyzed the properties of the miRNA-regulated drug-pathway network through genes and uncovered a number of novel MS agents by assessing their respective Z-values.A total of 20 likely drug candidates were identified, including human immunoglobulin, aspirin, alemtuzumab, minocycline, abciximab, alefacept, palivizumab, bevacizumab, efalizumab, tositumomab, minocycline, etanercept, catumaxomab, and sarilumab. Each of these agents were then explored with regards to their likely mechanism of action in treating MS.The current investigation provides a fresh perspective on MS biological mechanisms as well as likely treatment strategies.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma
    Trial primary completion date:  CATUNIBLA: Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC (clinicaltrials.gov) -  Apr 5, 2022   
    P1,  N=30, Recruiting, 
    Each of these agents were then explored with regards to their likely mechanism of action in treating MS.The current investigation provides a fresh perspective on MS biological mechanisms as well as likely treatment strategies. Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma
    Clinical, Journal:  Removal of EpCAM-positive tumor cells from blood collected during major oncological surgery using the Catuvab device- a pilot study. (Pubmed Central) -  Feb 24, 2022   
    The preliminary study results indicate efficacy and feasibility of the new medical device Catuvab allowing potentially the reinfusion of autologous erythrocyte concentrates (EC) produced by IBS device during oncological high blood loss surgery. An open-label, multicenter clinical study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the Catuvab device is initiated to validate these encouraging results.
  • ||||||||||  [VIRTUAL] Functional characterization of CD3specific DNA aptamers () -  Oct 2, 2021 - Abstract #ESGCT2021ESGCT_423;    
    More recently, bispecific therapies retargeting the cytotoxic activity of effector T cells by binding to CD3 to tumors expressing tumorassociated antigen have demonstrated striking activity in patients across different cancers (blinatumomab and catumaxomab)...Accordingly, these aptamers did not induce any activation of primary human T lymphocytes nor the internalization of CD3 receptors upon binding, which is of particular interest for the development of inert targeting agents without any immunomodulating properties. All together these lead CD3 aptamers exhibit unique properties and qualify for further preclinical and clinical development of CD3targeting therapeutics.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma, Blincyto (blinatumomab) / Astellas, Amgen
    [VIRTUAL] Engineering and functional characterization of antiPSMAxCD3 bispecific aptamers () -  Oct 2, 2021 - Abstract #ESGCT2021ESGCT_405;    
    In vitro cytotoxicity assays revealed that engineered PSMAxCD3 aptamers were able to recruit effector T lymphocytes to PSMApositive cells and trigger cytolysis when control monomer lacking the CD3 binding moiety were inactive. Based on these promising properties, PSMAxCD3 aptamers have been selected for further preclinical and clinical development as prostate cancer therapeutics.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma, Blincyto (blinatumomab) / Astellas, Amgen
    [VIRTUAL] Engineering and Functional Characterization of Anti-PSMAxCD3 Bispecific Aptamers () -  Apr 30, 2021 - Abstract #ASGCT2021ASGCT_435;    
    Engineered bispecific aptamers are thus able to recruit effector T lymphocytes to target cells to redirect their cytolytic machinery and eliminate a particular cell population. Based on these promising properties, PSMAxCD3 aptamers have been selected for further preclinical and clinical development as prostate cancer therapeutics.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion, Blincyto (blinatumomab) / Astellas, Amgen
    Review, Journal:  Bispecific antibodies targeting dual tumor-associated antigens in cancer therapy. (Pubmed Central) -  Dec 16, 2020   
    Based on these promising properties, PSMAxCD3 aptamers have been selected for further preclinical and clinical development as prostate cancer therapeutics. Dual TAAs targeting BsAbs represent a valuable class of biologics and early stage clinical studies have demonstrated promising anti-tumor efficacy in both hematologic malignancies and solid tumors.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion
    Preclinical, Journal, IO Biomarker:  Targeting EpCAM by a Bispecific Trifunctional Antibody Exerts Profound Cytotoxic Efficacy in Germ Cell Tumor Cell Lines. (Pubmed Central) -  May 24, 2020   
    In these GCT lines of variable EpCAM surface expression, targeting T cells by the prototypic bispecific EpCAM/CD3-antibody (bAb) Catumaxomab together with natural killer (NK) cell engagement via the Fc domain promotes profound cytotoxicity across a broad range of antibody dilutions...In the CHC line JAR, NK cell-dependent cytotoxicity dominates, which may be attributed to differential surface expression of immunomodulatory proteins such as MHC-I, CD24, and Fas receptors on CHC and EC. In view of redirecting T cell therapy mediated by bispecific antibodies, such differences in GCT immunophenotype potentially favoring immune escape are worth further investigation.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion, Blincyto (blinatumomab) / Astellas, Amgen
    Non-genetic generation of IgG-like immune cell-redirecting antibodies lacking effector function (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_2153;    
    Chemoenzymatic Conjugation of Toxic Payloads to the Globally Conserved NGlycan of Native mAbs Provides Homogeneous and Highly Efficacious Antibody−Drug Conjugates. Bioconj. Chem. 2015, 26, 2233-2242.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion
    Review, Journal:  Management of drainage for malignant ascites in gynaecological cancer. (Pubmed Central) -  May 2, 2020   
    Chem. 2015, 26, 2233-2242. Currently, there is insufficient evidence to recommend the most appropriate management of drainage for malignant ascites among women with gynaecological cancer, as there was only very low-certainty evidence from one small RCT at overall high risk of bias.
  • ||||||||||  citatuzumab bogatox (VB6-845) / Sesen Bio, Removab (catumaxomab) / NeoPharm, Trion, adecatumumab (MT201) / Amgen
    Journal:  Antibody based EpCAM targeted Therapy of Cancer, Review and update. (Pubmed Central) -  Oct 2, 2019   
    Anti EpCAM toxin conjugated antibodies Oportuzumab Monatox (scFv antibody and Pseudomonas exotoxin A (ETA)) and Citatuzumab Bogatox (Fab fragment with bouganin toxin) and also, immono-conjugate antibody Tucotuzumab (wholly monoclonal antibody with IL2), shown acceptable results in different clinical trials. Almost, all of the antibodies were well- tolerated; however, still more clinical trials are needed for approval of the antibodies for treatment of specific tumors.
  • ||||||||||  Hemlibra (emicizumab-kxwh) / Roche, Removab (catumaxomab) / NeoPharm, Trion, Blincyto (blinatumomab) / Astellas, Amgen
    Review, Journal:  Engineering IgG-Like Bispecific Antibodies-An Overview. (Pubmed Central) -  Sep 25, 2019   
    In addition, Emicizumab, which is a bispecific antibody targeting clotting factors IXa and X, was recently granted market approval by the FDA in 2017 for the treatment of hemophilia A. However, the generation of these next generation therapeutics is challenging and requires tremendous engineering efforts as two distinct paratopes need to be combined from two different heavy and light chains. This mini review summarizes technologies, which enable the generation of antibodies with dual specificities.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion
    Review, Journal:  Palliation of malignant ascites. (Pubmed Central) -  Jun 22, 2019   
    Options for durable symptom management include indwelling catheters, peritoneal ports, peritoneovenous shunts, intraperitoneal (i.p.) catumaxomab, and hyperthermic i.p. chemotherapy. These interventions do not necessarily improve overall survival but may improve QOL.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion, Blincyto (blinatumomab) / Astellas, Amgen
    Review, Journal:  Single-Chain Variable Fragment-Based Bispecific Antibodies: Hitting Two Targets with One Sophisticated Arrow. (Pubmed Central) -  Apr 25, 2019   
    Furthermore, approximately 60 bsAbs are under investigation in clinical trials. The current review aims at portraying different formats of the single-chain variable fragment (scFv)-based bsAbs and shedding light on the scFv-based bsAbs in preclinical development, different phases of clinical trials, and the market.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion Pharma
    Review, Journal:  Early Investigations and Recent Advances in Intraperitoneal Immunotherapy for Peritoneal Metastasis. (Pubmed Central) -  Aug 16, 2018   
    Moreover, IP immunotherapy with catumaxomab, a trifunctional antibody approved in Europe, targets epithelial cell adhesion molecule (EpCAM) and has shown considerable promise with control of malignant ascites. Herein, we discuss immunologic approaches under investigation for treatment of PM.