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Duobody clinical trial

duobody clinical trial went into its Thanksgiving holiday week, clinical trial news was quieter than usual, although there was a lot of important news on the COVID-19 vaccine front. Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. ” EBioMedicine. About Tisotumab Vedotin Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully 1Engelbert et al. Project Description. 2020 Feb;52: 102625. DuoBody ®-PD-L1x4-1BB targets PD-L1 and 4-1BB, selected to block inhibitory PD-1/PD-L1 axis and simultaneously activate essential co-stimulatory activity via 4-1BB using inert DuoBody ® antibody format. Subsequently, patients were immu-nized with GEN-009 with additional doses administered at 3, 6, 12, and 24 weeks. In addition, it appears to have a favorable pharmacokinetics profile in cancer patients. Assuming that Novo is successful in its efforts, Genmab stands to receive development, regulatory and sales milestones of roughly $250 million for each exclusive license Genmab and Janssen collaborate on the DuoBody platform to develop three BsAbs, JNJ-61186372 , JNJ-63709178 , and JNJ-61178104 , which are under evaluation in clinical trial phase I (Figure 1(a), I and Table 1). The study is currently enrolling (EudraCT No: 2017-001748-36). The trial consists of two parts: a dose escalation part (phase 1) and an expansion part (phase 2a). A Phase 1/2 clinical study of DuoBody ®-PD-L1x4-1BB in solid tumors is ongoing. The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in this setting. This is an open-label, randomized (1:1), multi-center trial of epcoritamab (GEN3013; DuoBody-CD3xCD20) versus prespecified investigator's choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody ® platform for generation of bispecific antibodies, the HexaBody ® platform Ida H Hiemstra's 7 research works with 18 citations and 951 reads, including: Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL Talquetamab (JNJ 7564) is being developed by Janssen Research & Development and Genmab, for the treatment of multiple myeloma. BliNK Biomedical Technology partnership “The achievement of starting a Phase I/IIa clinical trial with a product candidate developed in only four years is a validation of our highly productive partnership with Genmab,” said Prof. “DuoBody-PD-L1x4-1BB’s pan-cancer, dual-immuno-stimulatory mode of action contributes an additional layer of treatment Purpose of trial. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). 50:50 co-development Genmab and AbbVie. Food and Drug Administration (FDA) seeking accelerated approval for tisotumab vedotin. T cells can also be redirected to CLEC12A, with nonhuman primate data showing transient depletion of late myeloid cells in the bone marrow after a single dose . The candidate is a humanized The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the Genmab develops a broad clinical and pre-clinical product pipeline, and owns four antibody technologies, DuoBody bispecific platform, HexaBody platform, DuoHexaBody platform & HexElect platform The DuoBody platform is an innovative platform for the discovery and development of bispecific antibodies that may improve antibody therapy of cancer, autoimmune, infectious and central nervous About GEN1042 (DuoBody-CD40x4-1BB)GEN1042 (DuoBody-CD40x4-1BB) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. Of the Genmab-created products in clinical trials, we own six of them, at least 50%, and soon we will have seven as we submitted an IND for the first DuoHexaBody product candidates, DuoHexaBody Company Announcement. 21023884, Kalvebod Brygge 43, 1560 Copenhagen V, Denmark. CAR T therapy first demonstrated promising clinical efficacy in several phase 1 clinical trials JNJ-63709178 induces potent tumor cell killing in vitro, ex vivo, and in murine AML models, and is currently being evaluated in first-in-human clinical trials. As caregivers, we know how difficult it can be to find and understand your clinical trial options. Under the terms of the agreement, Genmab will receive an upfront payment of USD 5 million […] Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody ® platform for generation of bispecific antibodies, the HexaBody ® platform Data from a Phase 1 clinical trial has confirmed possible differentiation of lemzoparlimab in drug safety. The study involves cohorts of multiple REGN5845 dose levels administered intravenously. 3 About GEN1042 (DuoBody-CD40x4-1BB)GEN1042 (DuoBody-CD40x4-1BB) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. the DuoBody ® platform Epcoritamab (GEN3013; DuoBody-CD3×CD20) to induce complete response in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL): Complete dose escalation data and efficacy results from a phase I/II trial. DuoBody-CD3x5T4 (GEN1044) Latest in the Clinic. Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal value […] Life sciences companies are gearing up to enter new markets as they look to Company Announcement COPENHAGEN, Denmark; February 22, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that Tahamtan Ahmadi, M. It is being co-developed under an agreement in which the companies share all costs and future profits for the product on a 50:50 basis. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). 5T4 Genmab announces first patient dosed in study of DuoBody bispecific antibody: Copenhagen, Denmark Monday, May 23, 2016, 13:00 Hrs [IST] Genmab A/S announced that the first participants have been dosed in a clinical study of a DuoBody bispecific antibody under Genmab’s DuoBody technology platform collaboration with Janssen Biotech, Inc. “DuoBody-PD-L1x4-1BB’s pan-cancer, dual-immuno-stimulatory mode of action contributes Epcoritamab (DuoBody-CD3xCD20) is a bispecific antibody created using Genmab's proprietary DuoBody technology. DuoBody-CD3xCD20 induced highly potent T-cell activation and T-cell-mediated cytotoxicity towards malignant B cells in vitro. Summary The trial is an open-label, multi-center safety trial of epcoritamab GEN3013 (DuoBody®-CD3xCD20). 5T4 is a tumor antigen expressed in broad range of solid tumors with limited level of expression in healthy tissues. gov. ebiom. 2019. Epcoritamab is designed to target CD3, which is expressed on T cells and is part of the T cell receptor signaling complex, and CD20, a clinically well validated therapeutic target. As a single agent at a dose range up to 30mg without a priming dose, results have shown that lemzoparlimab is well tolerated. A phase 3 trial for the » Start multiple new MM trials » Progress non-MM indications Expand pipeline » Progress Ph I HuMax-TF-ADC study » Report progress pre-clin. Clinical Trial Details The purpose of this Phase 1 study is to find the highest dose of study drug JNJ 63709178 that can be given without causing severe side effects and to and see what effects (good and bad) it has in your AML. Clinical trial for Acute myeloid leukemia | Acute Myelogenous Leukemia (AML) , Dose Escalation Study of JNJ-63709178 a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) Danish biotech venture Genmab in partnership with American multinational pharmaceutical company AbbVie recently launched a Phase 3 clinical trial to investigate the efficacy of epcoritamab (GEN3013 DuoBody®–CD3xCD20) compared to the investigator’s choice of chemotherapy in patients with relapsed refractory diffuse large B-cell Lymphoma who have failed or are ineligible for HDT-ASCT. Participants will be monitored for adverse events caused by the treatment for up to 1. 2020 Feb;52: 102625. clinicaltrials. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company’s second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or Epcoritamab (DuoBody-CD3xCD20): uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack More information about the innovaTV 301 clinical trial, including enrolling sites, as well as other ongoing clinical trials is available at www. Below is a summary of business progress in 2020, financial performance for the year and the financial outlook for 2021. Food and Drug Administration (FDA) seeking accelerated As the U. The trial consists of two parts: a dose escalation part phase 1, first-in-human (FIH) and an expansion part phase 2a. , has been appointed to the newly created position of The outcome of B-cell precursor acute lymphoblastic leukemia (ALL) is different in children and adults, with overall survival (OS) rates at 5 years ranging from 90% to 45%. Perspectives and Conclusion. S. Genmab Enters Commercial License Agreement with Novo Nordisk for DuoBody Technology- Two commercial DuoBody® technology licenses granted to Novo Nordisk- Genmab receives USD 2 million upfront paymentCopenhagen, Denmark; August 14, 2015 — Genmab A/S (OMX: GEN) announced today it has entered an agreem The clinical development program for amivantamab in untreated advanced EGFR-mutated NSCLC includes the Phase 3 MARIPOSA and PAPILLON combination trials. Below is a summary of business progress in 2020, financial performance for the year and the financial outlook for 2021. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced the submission of a Biologics License Application (BLA) to the U. And soon, we Despite COVID-19 lockdowns and much of the country blanketed by snow, Canadians still couldn’t be kept out of the real estate market in January. DuoBody-CD3xCD20 potently inhibited outgrowth of CD20-expressing tumors (Raji) in vivo, even in the presence of high doses of Fc-inactive rituximab, demonstrating that the anti-tumor Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody ® delays in planned clinical trial initiations, enrollment and conduct Teclistamab has been investigated in 4 clinical trials, of which 4 are open and 0 are closed. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Epcoritamab is designed to simultaneously This pilot clinical trial studies Salvia hispanica seed in reducing the risk of returning disease (recurrence) in patients with non-Hodgkin lymphoma. CDX and PDX mouse models, DuoBody-CD3x5T4 showed anti-tumor activity, in addition to PD biomarkers associated with T-cell activation in the tumor and periphery. More info Technology. Methods A cohort of 15 adults with solid tumors were enrolled in the study. JNJ-64007957 is a bi-specific antibody, a new kind of drug which has two targets. It is for people with B-cell non-Hodgkin lymphoma that is getting worse (progressing), has come back or has not responded to other treatment. Here’s a look. 04, 2021 * Initiation of a global phase 3 trial for tisotumab vedotin versus investigator’s choice chemotherapy in recurrent or metastatic cervical cancer Talquetamab has been investigated in 3 clinical trials, of which 3 are open and 0 are closed. Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. in Tokyo, Japan. Currently, 57 bsAbs, including blinatumomab, are in clinical trials in cancer patients (Table S1) of which 38 use the same mechanism of action: engagement of immune cells with tumor cells. Genmab Announces Very Favorable Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer Genmab A/S Tel: +45 7020 2728 Company Announcement no. S. Ugur Sahin, CEO of BioNTech. clinicaltrials. in Utrecht, The Netherlands, Genmab U. Unique mechanism-of-action. Email Print Friendly Share. 5, The production and development of the antibody followed Janssen’s licensing agreement with Genmab for use of its DuoBody ® technology platform. About Cervical Cancer Cervical cancer originates in the cells lining the cervix. Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund. “The achievement of starting a Phase I/IIa clinical trial with a product candidate developed in only four years is a DuoBody-PD-L1x4-1BB is a novel bispecific antibody that combines “The achievement of starting a Phase I/IIa clinical trial with a product candidate developed in only four years is a validation of our highly productive partnership with Genmab,” said Prof. S. Since its discovery in 1992, accumulating evidence has demonstrated that BCMA is a promising target for immunotherapy in MM (Table 2). Genmab has entered an agreement to grant Gilead Sciences an exclusive license and an option on a second exclusive license, to use the DuoBody technology platform to create and develop bispecific antibody candidates for a therapeutic program targeting HIV. The study is currently enrolling (EudraCT No: 2017-001748-36). The company is based in Copenhagen, Denmark - internationally, it operates through the subsidiaries Genmab B. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule. FDA TEPEZZA ® (teprotumumab) approved in U. PMID: 31981978; PMCID: PMC6992935. 17,18 *RECIST (version 1. First DuoBody ® product candidate (amivantamab) awarded Breakthrough Therapy Designation by U. 102625. 5% ORR in HL patients at the dose selected for Phase 2. CD20 is expressed on a majority of B cell malignancies. gov Identifier NCT03917381) consists of two parts: a dose escalation part (Phase I, first-in-human) and an expansion part (Phase Epcoritamab (DuoBody-CD3xCD20): uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack The first clinical trial in humans was performed in 1990 using a coupled antibody with specificity to T-cell-receptor and glioma antigen in glioblastoma patients. We're on a mission to change this. S. The first bsAb in haematologic malignancies might be a clinical trial using a CD19 × CD3 antibody in Non-Hodgkin-lymphoma (NHL) in 1995. We conduct an active program of basic and clinical research aimed at improving the outcomes of Currently, DuoBody-CD3x5T4 is being investigated in a first-in-human clinical trial for the treatment of solid tumors ( NCT04424641 ), in which exploratory biomarker analyses to study the clinical DuoBody ® is a registered 11 Clinicaltrials. Provide oncologists and hematologists with a 3D animation of Genmab’s DuoBody™ technology platform and visually explain the science of bispecific antibodies: single molecules that can bind specifically and simultaneously to two different targets, such as receptors or ligands. Clinical Trials Dose Escalation Study of Teclistamab, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma ID#: NCT03145181 The EU Clinical Trials Register currently displays 39354 clinical trials with a EudraCT protocol, of which 6447 are clinical trials conducted with subjects less than 18 years old. Genmab Announces Very Favorable Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer. Gen3013 (DuoBody®-CD3xCD20) is bispecific antibody created using Genmab's proprietary DuoBody® technology. gov. JNJ-63709178 in clinical trials. Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund. About Seagen Janssen Presents Findings from Global, Multi-Centre Trial Examining Amivantamab in Combination with Lazertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer Phase 1b study shows Epcoritamab is designed to target CD3, which is expressed on T cells and is part of the T cell receptor signaling complex, and CD20, a clinically well-validated therapeutic target. Ugur Sahin, CEO of BioNTech. “DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Company Announcement Based on these data, Genmab has initiated a First-in-Human clinical trial to evaluate the safety and preliminary efficacy of DuoBody-CD3xCD20 by subcutaneous administration in patients with B-cell malignancies. 1 XmAb ® technology is an investigational immunomodulatory platform consisting of engineered fragment crystallizable (Fc) domains with selective high affinity binding to Clinical Trial Outcome Measures Primary Measures. Of the Genmab created products in clinical trials, we own six of them at least 50%. And since there are so few homes available to satisfy the demand, prices as measured by the MLS Home Price Index rose 13. December 5, 2020 (RARITAN, N. The trial consists of two parts: a dose escalation part phase 1, first-in-human (FIH) and an expansion part phase 2a. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined. The trial consists of two parts: a dose escalation part (phase 1, first-in-human (FIH) and an expansion part phase 2a). ) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today initial data for the Phase 1 first-in-human dose escalation study of talquetamab (JNJ-64407564) for the treatment of relapsed or refractory multiple myeloma (NCT03399799). 5 years to assess its This site is intended for health care providers to identify open clinical trials. for Thyroid Eye Disease DARZALEX ® (daratumumab) approved in Europe for use in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects with Advanced Non-Small CellLung Cancer Epcoritamab (previously DuoBody CD3xCD20) is a humanised immunoglobulin 1 (IgG1) bispecific antibody, being developed by Genmab for the treatment of Epcoritamab - Genmab - AdisInsight Either you have JavaScript disabled or your browser does not support Javascript . The study objectives are to assess the safety, tolerability and pharmacokinetics (PK) of the oral RAD51 inhibitor CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients. Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. D. Genmab CEO Jan van de Winkel said: "Our proprietary DuoBody technology can be used to create bispecific antibodies that target a wide variety of disease areas. Yet, less than 1 out of every 10 myeloma patients will ever participate in a clinical trial. gov. the DuoBody Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) - NCT02715011 Based on these data, Genmab has initiated a First-in-Human clinical trial to evaluate the safety and preliminary efficacy of DuoBody-CD3xCD20 by subcutaneous administration in patients with B-cell malignancies. A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma: Actual Study Start Date : November 16, 2020: Estimated Primary Completion Date : January 30, 2022: Estimated Study Completion Date : September 30 Brief Summary: The trial is an open-label, multi-center satefy and efficacy trial of epcoritamab in relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Based on these preclinical studies, a clinical trial was initiated to assess the clinical safety of subcutaneous DuoBody-CD3xCD20 in patients with B-cell malignancies. To target cancer cells expressing BCMA, we developed a BCMAxCD3 bispecific antibody using the Genmab DuoBody® technology (Ab-957) to recruit T cells to BCMA-expressing MM cells so that T cells could be activated and induced to kill BCMA + cancer cells. The Canadian Real Estate Association says sales were up 35. a clinical trial to assess the safety and preliminary ef fi cacy of subcutaneous DuoBody-CD3xCD20 (GEN3013) in patients with relapsed, progressive or refractory B-cell lymphoma is currently These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule. S. CD3 bispecific, T cell mediated cytotoxicity of 5T4+ tumor cells. "Today’s agreement with Novo Nordisk is an example of how we can leverage access to our unique state-of-the art antibody expertise and collaborations to generate diverse revenue Under the leadership of Ajai Chari, MD, our clinical trials program provides access to novel, life-saving treatment approaches that incorporate vaccines and new agents that are often not available outside the clinical trial setting. Copenhagen, Denmark; February 23, 2021 – Genmab A/S (Nasdaq: GMAB) announced today the publication of its Annual Report for 2020. Dose Limiting Toxicity (DLT) Time Frame: Up to Day 28; The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher. Dose Escalation Study of Teclistamab, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. (Janssen). Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab (JNJ-64007957), a Humanized BCMA x CD3 DuoBody® Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma Cancer Category Hematologic (Blood Cancers) Age Group Adult Phase Phase I/II DuoBody-CD3x5T4 (GEN1044) Latest in the Clinic Based on proprietary DuoBody technology CD3 bispecific, T cell mediated cytotoxicity of 5T4+ tumor cells 5T4 expressed on multiple solid tumors limited expression in healthy tissue Potent anti-tumor activity in diversity pre-clinical models The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy. Azymetric CDX and PDX mouse models, DuoBody-CD3x5T4 showed anti-tumor activity, in addition to PD biomarkers associated with T-cell activation in the tumor and periphery. Epcoritamab is designed to target CD3, which is expressed on T cells and is part of the T cell receptor signaling complex, and CD20, a clinically well validated therapeutic target. These trials are This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. Clinical Trials. Functional foods, such as Salvia hispanica seed, has health benefits beyond basic nutrition by reducing disease risk and promoting optimal health. K. This full-length BiTE was shown to be highly active in vitro with low picomolar EC 50 towards a diverse panel of B cell lines. Epub 2020 Jan 23. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined from phase 1. for Thyroid Eye Disease DARZALEX ® (daratumumab) approved in Europe for use in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed The EU Clinical Trials Register currently displays 39327 clinical trials with a EudraCT protocol, of which 6443 are clinical trials conducted with subjects less than 18 years old. S. These trials are This phase I clinical trial aims to elucidate the maximal tolerated dose and side effects of pomalidomide in patients with relapsed or refractory primary central nervous system lymphoma or newly diagnosed or relapsed or refractory vitreoretinal lymphoma (Intraocular lymphoma). Ugur Sahin, CEO of BioNTech. Seagen Inc. The aim of this trial is to establish the safety and work out the best dose of a new treatment called GEN3013 (also called DuoBody ®-CD3xCD20). Unique mechanism-of-action. humanized bcma/cd3 duobody antibody jnj-64007957, bcma x cd3 duobody The path towards newer, better therapies and one day a cure for myeloma, is through clinical trials. View select clinical trials with ABBV-744 now. To view a full list of clinical trials in which ABBV-744 is being investigated, please visit ClinicalTrials. Ugur Sahin, CEO of BioNTech. “DuoBody-PD-L1x4-1BB’s pan-cancer, dual-immuno-stimulatory mode of action contributes an additional layer of treatment It is a DuoBody drug combining CD3 and CD20 targeting which is in trials for B cell malignancies. Genmab A/S (Nasdaq: GMAB) announced today that two posters evaluating investigational medicines created using Genmab’s DuoBody® technology will be presented at the American Association for Cancer Research Annual Meeting 2021, taking place virtually April 10-15 and May 17-21. Comparison of DuoBody-CD3xCD20 to CD3 bsAb targeting alternative B-cell antigens, or to CD3xCD20 bsAb generated using alternative CD20 Ab, emphasized its exceptional potency. To view a full list of clinical trials in which ABBV-744 is being investigated, please visit ClinicalTrials. Genmab Enters Commercial License Agreement with Novo Nordisk for DuoBody Technology PDF Company Announcement uncertainties related to the outcome and conduct of clinical trials including Currently, DuoBody-CD3x5T4 is being investigated in a first-in-human clinical trial for the treatment of solid tumors ( NCT04424641 ), in which exploratory biomarker analyses to study the clinical For DuoHexaBody-CD37, DuoBody-CD3x5T4 and any product candidates developed as a result of the companies' discovery research collaboration, Genmab and AbbVie will share responsibilities for global Speak with a clinical trial navigator Monday-Friday, 9:00am to 5:00pm Toll Free: 1-855-216-0098 or Request a Contact View Clinical Trials The Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics provides comprehensive care to patients with multiple myeloma, including promising new therapies through clinical trials rooted in an approach that brings laboratory discoveries quickly to the clinical setting. gov. Over 13,500 women are expected to be diagnosed with invasive cervical cancer in the U. 2 Cervical cancer remains one of the Clinical Trial data last updated Mar 23, 2021. Clinical Trials Nct Page Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Subjects With Relapsed or Refractory AML “The achievement of starting a Phase I/IIa clinical trial with a product candidate developed in only four years is a validation of our highly productive partnership with Genmab,” said Prof. gov/ct2/show About GEN1042 (DuoBody-CD40x4-1BB) GEN1042 (DuoBody-CD40x4-1BB) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. First DuoBody ® product candidate (amivantamab) awarded Breakthrough Therapy Designation by U. genmab. 2019. Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation ABBV-744 monotherapy is being studied in a phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia (AML) and myelofibrosis (MF). For DuoHexaBody-CD37, DuoBody-CD3x5T4 and any product candidates developed as a result of the companies' discovery research collaboration, Genmab and AbbVie will share responsibilities for global The DuoBody platform is an innovative platform for the discovery and development of bispecific antibodies that may improve antibody therapy of cancer, autoimmune, infectious and central nervous system disease. DuoBody ®-PD-L1×4-1BB In a Phase 1B clinical trial of NEO-PV-01, seven vaccine doses are administered over a 3-month period post-chemotherapy and pembrolizumab. 50:50 co-development Genmab and AbbVie. 1016/j. Company’s second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an 86. About Epcoritamab (DuoBody-CD3xCD20) Epcoritamab (DuoBody-CD3xCD20) is a bispecific antibody created using Genmab's proprietary DuoBody technology. Clinical Trials. Epcoritamab (DuoBody-CD3xCD20) Potential for Improved Efficacy & Safety in B Cell Malignancies Potential best-in-class therapeutic T cell-mediated killing of CD20-expressing cells SubQ Ph 1/2 trials in B cell malignancies ongoing 50:50 co-development Genmab and AbbVie X m A b ® antibody. in Tokyo, Japan. Novel target for hematologic malignancies. The company is based in Copenhagen, Denmark - internationally, it operates through the subsidiaries Genmab B. 1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized GPRC5D x CD3 DuoBody® Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma GCO# 17-2163,ClinicalTrials. A clinical trial (NCT03761108) of a first-in-human study of the drug was initiated in January 2019, in patients with R/R MM. Disclaimer Legal Notice. The drug is being 50-50 co-developed with AbbVie (NYSE: ABBV ) . “DuoBody-PD-L1x4-1BB’s pan-cancer, dual-immuno-stimulatory mode of action contributes an additional layer of treatment JNJ-6372 is an EGFR-MET bispecific antibody with immune cell-directing activity that targets activating and resistant EGFR and MET mutations and amplifications. The topline results from the phase 2 study were announced in June 2020 and data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. 2. FDA TEPEZZA ® (teprotumumab) approved in U. This website is provided by Genmab A/S, CVR no. Based on proprietary DuoBody technology. A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64007957, a Humanized BCMA x CD3 DuoBody® Antibody in Subjects With Relapsed or Refractory Multiple Myeloma The purpose of this study is to identify the recommended Phase 2 dose (s) (RP2Ds) and schedule First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody ® -PD L1×4-1BB (GEN1046) in patients with advanced solid tumors – e-poster presentation, available It is a CD3-targeting bispecific antibody and induces T-cell mediated cytotoxicity of 5T4+ tumor cells. Dose escalation ongoing. Although CD123 is distinctively expressed on leukemic cells, some populations of normal myeloid cells have been reported to express CD123. Please read this Legal Notice before using this website. About GEN1042 (DuoBody-CD40x4-1BB)GEN1042 (DuoBody-CD40x4-1BB) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. Dose Escalation Study of Teclistamab, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. During the screening period, patients received standard of care PD-1-based immunotherapies appro-priate for their tumor type. More information about the innovaTV 301 clinical trial, including enrolling sites, as well as other ongoing clinical trials is available at www. 1016/j. Urovant's Irritable Bowel Drug Fails in Phase II; Genmab Abandons Cancer Drug Combination of DuoBody & HexaBody platforms. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the Preliminary data from a Phase 1/2 study of DuoBody-PD-L1x4-1BB (BNT311/GEN1046) in advanced solid tumors as well as preclinical data from the program have been accepted for eposter presentations. DuoBody ®; DuoBody in The EU Clinical Trials Register currently displays 39349 clinical trials with a EudraCT protocol, of which 6447 are clinical trials conducted with subjects less than 18 years old. DuoBody-PD­-L1×4-1BB, a first-in-class, bispecific, next-generation checkpoint immunotherapy, was The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part 2. , Inc. 16-190: Phase 3, Randomized, Double-Blind Study of Venetoclax or Placebo in Combination with Seven-Day Azacitidine for Treatment-Naïve Elderly Subjects with Acute Myeloid Leukemia (AML The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy. jnj-64407564, jnj 64407564, humanized gprc5d x cd3 duobody antibody 1/2a clinical trial (NCT03633110). Ugur Sahin, CEO of BioNTech. 3-5 In both ALL and NHL, many patients fail Finland's Fortum on Monday moved closer to full control over Uniper after the German utility's CEO and finance chief both stepped down with immediate effect after less than three years in the job. The trial is an open-label, multi-center safety trial of GEN3013 (DuoBody®-CD3xCD20). clinicaltrials. o Operating expenses increased by DKK 1,070 million, or 39%, from DKK 2,728 million in 2019 to DKK 3,798 million in 2020 driven by the advancement of epcoritamab (DuoBody-CD3xCD20) and DuoBody-PD 412 First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD-L1×4–1BB (GEN1046) in patients with advanced solid tumors November 2020 Journal for The trial is an open-label, multi-center safety trial of epcoritamab GEN3013 (DuoBody-CD3xCD20). 1. “The achievement of starting a Phase I/IIa clinical trial with a product candidate developed in only four years is a validation of our highly productive partnership with Genmab,” said Prof. 102625. gov Identifier: NCT03399799 Combination of DuoBody & HexaBody platforms. S. ADC, DuoBody & HexaBody projects Next generation technologies » Enter new DuoBody technology collaborations » Report progress DuoBody collaborations » Start HexaBody technology collaborations Another construct, an anti-CD123/CD3 duobody, is currently being tested in a phase I clinical trial (NCT02715011). 1,3. ebiom. Initiation of a global phase 3 trial for tisotumab vedotin versus investigator’s choice chemotherapy in recurrent or metastatic cervical cancer For more information about the Phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www. The investigational drug at the center of the deal, epcoritamab, or DuoBody-CD3xCD20, is in clinical testing as a treatment for multiple hematological B cell malignancies. Currently, DuoBody-CD3x5T4 is being investigated in a first-in-human clinical trial for the treatment of solid tumors (NCT04424641), in which exploratory biomarker analyses to ABBV-744 monotherapy is being studied in a phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia (AML) and myelofibrosis (MF). This is the first time JNJ-63709178 is being given to humans. Two BsAbs have been developed against these two targets and are currently in a phase I clinical trial: RG6160 which targets FcRL5 (NCT03275103) and the DuoBody JNJ-64407564 which targets GPRC5D (NCT03399799) . In addition, preliminary data from the first in-human dose escalation trial of intratumoral immunotherapy BNT131 (SAR441000) in collaboration with DuoBody-CD3xCD20 (GEN3013) is a bispecific antibody (bsAb) recognizing the T-cell antigen CD3 and the B-cell antigen CD20, that triggers potent T-cell-mediated lysis of CD20-expressing cells. Media Release COPENHAGEN, Denmark, Jan. Different from blina, this DuoBody is a full-length bispecific IgG1 immunoglobulin with an effector function-silenced Fc region. S. The trial is an open-label, multi-center safety trial of epcoritamab GEN3013 (DuoBody-CD3xCD20). in Princeton, USA, and Genmab K. S. in Princeton, USA, and Genmab K. Epcoritamab is currently in a Phase I/II clinical trial for B-cell non-Hodgkin lymphoma. for DuoBody Platform Genmab enters DuoBody™ technology collaboration $3. 5 million upfront payment to Genmab Copenhagen, Denmark; Genmab's proprietary products for the treatment of cervical cancer, ovarian cancer, solid tumors, hematological malignancies are in various phases of trial ranging from Phase 1/2 to Phase 2. The DuoBody ® technology involves three basic steps to generate stable bispecific human IgG1 antibodies. Clinical Trials. DuoBody-CD3x5T4 (GEN1044) Latest in the Clinic. For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www. Acute Myeloid Leukemia Clinical Trials at the Mario Lemieux Center for Blood Cancers To learn more or speak with a trial coordinator, please call 412-864-6600 . in Utrecht, The Netherlands, Genmab U. Uniper Chief Executive Andreas Schierenbeck, who joined the firm in 2019, will be replaced by Supervisory Board Chairman Klaus-Dieter Maubach, Uniper said, confirming what sources told Reuters Mim8 is the first DuoBody product candidates being evaluated in an indication outside of oncology. gov Identifier NCT03917381) consists of two parts: a dose escalation part (Phase I, first-in-human) and an expansion part (Phase The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the A Phase II Clinical Trial of BMN 673 in BRCA1 and BRCA2 Wild-Type Patients With (i) Advanced Triple-Negative Breast Cancer and Homologous Recombination Deficiency as Assessed by the HRD Assay, and (ii) Advanced HER2-Negative Breast Cancer With Either a Germline or Somatic Mutation in The Duobody technology provides unsurpassed opportunities for the generation and development of bispecific antibodies (bsAb) as biopharmaceuticals. gov. Results from seven patients after 4 weeks of treatment showed four responses, of which two were MRD negative. About Genmab DuoBody-PD-L1x4-1BB (GEN1046)1:First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD L1×4-1BB (GEN1046) in patients with advanced solid tumors The open-label safety trial of DuoBody-PD-L1x4-1BB (ClinicalTrials. A Phase 1 clinical study of DuoBody®-CD3x5T4 in malignant solid tumors was initiated in July 2020. com Page 1/3 1560 Copenhagen V, Denmark CVR no. V. The trial consists of two parts: a dose escalation part phase 1, first-in-human (FIH) and an expansion part phase 2a. K. Clinical Trial: Dose Escalation Study of JNJ-64007957, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma This trial is evaluating dose escalation and expansion of a new Janssen drug called JNJ-64007957. We offer patients emerging, promising therapies and new drugs with the goal of improving outcomes. Both showed in vitro and in vivo B-cell depletion and tumor growth suppression in myeloma models (35, 109). Available at: https://clinicaltrials. In initial trials, the ADC GSK2857916 and the BiTE AMG 420 have demonstrated high response rates in relapsed/refractory patients, with depth and durability of responses that may end up rivaling Company Announcement. In a first step, two IgG1s, each containing single matched mutations in the third constant (C H 3) domain (lysine at position 409 to arginine, K409R; phenylalanine at position 405 to leucine, F405L), are produced separately using recombinant mammalian expression systems (Figure Genmab A/S (Nasdaq: GMAB) announced today that two posters evaluating investigational medicines created using Genmab’s DuoBody® technology will be presented at the American Association for Cancer DuoBody®-CD3xCD20 (GEN3013) is a novel BiTE targeting CD20-expressing B cells . PRESS RELEASE GlobeNewswire . In 2019, DuoBody ®-PD-L1x4-1BB and DuoBody ®-CD40x4-1BB were the first product candidates from this partnership to enter clinical development. View select clinical trials with ABBV-744 now. “DuoBody-PD-L1x4-1BB’s pan-cancer, dual-immuno-stimulatory mode of action contributes an additional layer of treatment Based on these preclinical studies, a clinical trial was initiated to assess the clinical safety of subcutaneous DuoBody-CD3xCD20 in patients with B-cell malignancies. Of the remaining 19 bsAbs in clinical trials, five deliver a payload to tumors and 14 are blocking signaling in the cancer environment. D. gov. CD3 bispecific, T cell mediated cytotoxicity of 5T4+ tumor cells. ” EBioMedicine. The EU Clinical Trials Register currently displays 39097 clinical trials with a EudraCT protocol, of which 6413 are clinical trials conducted with subjects less than 18 years old. 5, The production and development of the antibody followed Janssen’s licensing agreement with Genmab for use of its DuoBody ® technology platform. Here are some examples of formats currently in the preclinical or Phase I clinical trial phase which demonstrate the strong potential of this class of compounds as biotherapeutics and the importance of choosing the right format: CrossMAb, DuoBody, κλ-body, SEEDbody, nanobody, BiTE, DART … information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www. The Company is also DuoBody®-CD3xCD20 (GEN3013) is a bispecific antibody (bsAb), recognizing the T-cell antigen CD3 and the B-cell antigen CD20, that triggers potent T-cell-mediated lysis of CD20-expressing cells. The trial consists of two parts, a dose escalation phase (phase Ib) and an expansion phase (phase II). Currently, DuoBody-CD3x5T4 is being investigated in a first-in-human clinical trial for the treatment of solid tumors (NCT04424641), in which exploratory biomarker analyses to The proposed clinical trial will study the effects of 12 months of therapy with ARN-509 alone, or in combination with an LHRH agonist (LHRHa), each compared to LHRHa alone, in men with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. DuoBody-CD3x5T4 is a bispecific antibody (bsAb) that crosslinks CD3 on T cells with 5T4 on tumor cells, thereby inducing T-cell activation and T-cell mediated cytotoxicity in 5T4-expressing tumor cells. 1,2 Significant needs also remain unmet in patients with B-cell non-Hodgkin lymphoma (NHL), with rates of refractory disease up to 20% according to histology in the rituximab era. S. 5T4 The open-label safety trial of DuoBody-PD-L1x4-1BB (ClinicalTrials. However, toxicity and a narrow therapeutic window have hampered their clinical development. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined. Background The tumor-associated antigen 5T4 is expressed across a wide range of solid cancers. The launch and conduct of Phase I/II clinical trials following submission of INDs and/or CTAs in 2019 for DuoBody-PD-L1x4-1BB, DuoBody-CD40x4-1BB, and DuoHexaBody-CD37. - Submission Based on Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 - Seagen Inc. clinicaltrials. References 6 Engelbert et al. DuoBody is designed for discovering and developing bispecific antibodies, with the goal of improving antibody therapy for cancer, autoimmune, infectious, and central nervous system disease. . in 2020, with approximately 4,200 deaths. doi: 10. The trial is an open-label, multi-center safety trial of GEN3013 (DuoBody®-CD3xCD20). Dose escalation ongoing. The study was conducted by Genmab in collaboration with Seagen, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG) Foundation. J. Based on proprietary DuoBody technology. The DuoBody platform was designed to aid development of antibody therapies not only for cancer, but also for autoimmune, infectious and central nervous system (CNS) diseases. The trial is an open-label, multi-center safety trial of epcoritamab GEN3013 (DuoBody®-CD3xCD20). The results of the tisotumab vedotin phase 2 clinical trial are encouraging as they demonstrate clinically meaningful, durable responses with a manageable side effect profile. gov. Based on these preclinical studies, a clinical trial was initiated to assess the clinical safety of subcutaneous DuoBody-CD3xCD20 in patients with B-cell malignancies. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. 26 Kalvebod Brygge 43 www. The early phase clinical trial of BION-1301, a fully humanized 01A mAb, is ongoing . (Janssen). Title: First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD L1×4-1BB (GEN1046) in patients with advanced solid tumorsPoster Presentation Date The EU Clinical Trials Register currently displays 39219 clinical trials with a EudraCT protocol, of which 6426 are clinical trials conducted with subjects less than 18 years old. clinicaltrials. Copenhagen, Denmark; February 23, 2021 – Genmab A/S (NASDAQ:GMAB) announced today the publication of its Annual Report for 2020. Background Agonistic 4-1BB monoclonal antibodies were preclinically validated as promising cancer immunotherapies, both as monotherapy and as potentiators of the activity of PD-(L)1–blocking agents. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). This presentation will highlight recent examples of Duobody molecules directed against a number of relevant tumor targets. About Cervical Cancer Cervical cancer Genmab Announces Very Favorable Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer. gov. “DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. 10. , Ph. doi: 10. Genmab Enters Commercial License Agreement with Novo Nordisk for DuoBody Technology PDF Company Announcement uncertainties related to the outcome and conduct of clinical trials including Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. NCI ID Cancer a Humanized BCMA x CD3 DuoBody® Antibody in Subjects With Relapsed or Refractory Multiple Myeloma Media Release COPENHAGEN, Denmark, Jan. The presence of an Fc domain increases the in vivo half-life through binding to the neonatal Fc receptor. , Inc. Genmab announces first patient dosed in study of DuoBody bispecific antibody: Copenhagen, Denmark Monday, May 23, 2016, 13:00 Hrs [IST] Genmab A/S announced that the first participants have been dosed in a clinical study of a DuoBody bispecific antibody under Genmab’s DuoBody technology platform collaboration with Janssen Biotech, Inc. The trial is an open-label, multi-center safety trial of GEN1044. If you are a patient or a member of the community, please visit BeInvolved for clinical trial information and search options. to expand on our own pioneering work in target discovery, protein therapeutics, and bispecific and multispecific antibodies with the XmAb ® antibody platform. ” the DuoBody The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with bevacizumab if eligible per local standards. “The achievement of starting a Phase I/IIa clinical trial with a product candidate developed in only four years is a validation of our highly productive partnership with Genmab,” said Prof. The trial consists of two parts: a dose escalation part phase 1, first-in-human (FIH) and an expansion part phase 2a. 2 per cent year-over-year nationally — a record for the month. V. About GEN1042 (DuoBody-CD40x4-1BB) GEN1042 (DuoBody-CD40x4-1BB) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. 04, 2021. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced the submission of a Biologics License Application (BLA) to the U. 5 Janssen to Highlight Commitment to Lung Cancer Science and Innovation with Eight Data Presentations at the International Association for the Study of Lung Cancer's 2020 World Conference on Lung Cancer For DuoHexaBody-CD37, DuoBody-CD3x5T4 and any product candidates developed as a result of the companies' discovery research collaboration, Genmab and AbbVie will share responsibilities for global CD3 bsAbs in clinical trials either lack an Fc region or contain an engineered Fc domain to minimize interaction with Fc receptors. Direct comparison in vitro demonstrated that DuoBody-CD3xCD20 was ∼100-fold more potent than another CD3xCD20 bsAb that is currently tested in clinical trials. Novel target for hematologic malignancies. Janssen initiated a first-in-human Phase 1 dose-escalation clinical trial (NCT02715011) with the aim of determining a recommended dose and schedule for JNJ-63709178 that can be used in Phase 2 studies. The trial consists of two parts: a dose escalation part (phase 1, first-in-human (FIH) and an expansion part phase 2a). Amgen is collaborating with Xencor, Inc. Here, we tested the capacity of DuoBody-CD3x5T4 to engage different T-cell subsets in vitro and JNJ-6372 is an EGFR-MET bispecific antibody with immune cell-directing activity that targets activating and resistant EGFR and MET mutations and amplifications. Clinical Trial of YH25448 in Patients With EGFR Mutation Positive Advanced NSCLC. The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in this setting. It is designed to target CD3, which is expressed on T cells and is part of the T cell receptor signaling complex, and CD20, a clinically well validated therapeutic target. Genmab Enters Broad Collaboration with Janssen Biotech, Inc. duobody clinical trial