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Genmab A/S Genmab Announces Multiple Abstracts To Be Presented At The 63rd Annual Meeting And Exposition Of The American Society Of Hematology (ASH)

04/11/2021 1:06pm

UK Regulatory (RNS & others)


Media Release

Copenhagen, Denmark, November 4, 2021

   -- Poster presentations highlighting safety and preliminary efficacy data of 
      epcoritamab (DuoBody(R)-CD3xCD20) in combination with other treatments in 
      patients with B-cell non-Hodgkin lymphoma (NHL) 
   -- Poster presentation highlighting preliminary data from clinical trial 
      evaluating epcoritamab in patients with chronic lymphocytic leukemia 
   -- More than 20 abstracts evaluating Genmab owned and partnered programs 
      accepted for presentation at ASH 
   -- Genmab to host virtual 2021 R&D Update and ASH Data Review meeting 
      December 14 

Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating several investigational medicines in the company's pipeline, or created using Genmab's innovative drug development platforms, will be presented at the 63(rd) Annual Meeting and Exposition of the American Society of Hematology (ASH), being held at the Georgia World Congress Center, in Atlanta, GA, and virtually, December 11-14. The presentations will include data from the phase 1b/2 EPCORE(TM) NHL-2 clinical trial evaluating the safety and preliminary efficacy of epcoritamab (DuoBody(R)-CD3xCD20) in various combinations for the treatment of patients with B-cell non-Hodgkin lymphoma (NHL). In addition, preliminary data from the phase 1b/2 EPCORE(TM) CLL-1 clinical trial, evaluating epcoritamab in patients with relapsed, refractory chronic lymphocytic leukemia (CLL), will be presented. Results from more than 20 clinical trials evaluating Janssen Biotech, Inc. (Janssen)'s daratumumab, the subcutaneous formulation of daratumumab, and Janssen's bispecific programs leveraging Genmab's DuoBody technology platform, will be presented.

All abstracts accepted for presentation have been published on the ASH website .

Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV). Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a research and license agreement to create and develop bispecific antibodies using Genmab's DuoBody technology platform.

"The data being presented at this year's ASH represent our focus on harnessing the power of antibodies to develop differentiated cancer treatments and our commitment to delivering new therapeutic options to patients through our own research and development and through industry partnerships," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are especially encouraged by the data from the early-stage epcoritamab clinical trials and look forward to seeing results from additional studies."

On Tuesday, December 14, at 2:00 PM EST (8:00 PM CET / 7:00 PM GMT), Genmab will host its 2021 Virtual R&D Update and ASH Data Review. The event will be webcast live. Details, including the webcast link, will be available on Genmab's website, This meeting is not an official program of the ASH Annual Meeting.

Abstracts accepted for presentation at ASH include:

Epcoritamab (DuoBody-CD3xCD20):

   -- Subcutaneous Epcoritamab in Combination with R-CHOP in Patients with 
      Previously Untreated High-Risk Diffuse Large B-cell Lymphoma: Preliminary 
      Results from a Phase 1/2 Trial 
   -- Subcutaneous Epcoritamab in Combination with R2 (Rituximab and 
      Lenalidomide) in Patients with Relapsed or Refractory Follicular 
      Lymphoma: Preliminary Results from a Phase 1/2 Trial 
   -- Subcutaneous Epcoritamab in Patients with Relapsed/Refractory Chronic 
      Lymphocytic Leukemia: Preliminary Results from the EPCORE CLL-1 Trial 
   -- Phase 3 Trial (EPCORE DLBCL-1) of Epcoritamab versus Standard of Care in 
      Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma 


   -- Daratumumab (DARA) with Bortezomib, Thalidomide, and Dexamethasone (VTd) 
      in Transplant-Eligible Patients (Pts) with Newly Diagnosed Multiple 
      Myeloma (NDMM): Analysis of Minimal Residual Disease (MRD) Negativity in 
      CASSIOPEIA Part 1 and Part 2 
   -- Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Based on 
      Lenalidomide Starting Dose in Transplant-ineligible Patients With Newly 
      Diagnosed Multiple Myeloma and Impaired Renal Function From the Phase 3 
      MAIA Study 
   -- Subcutaneous Daratumumab With Bortezomib, Cyclophosphamide, and 
      Dexamethasone (VCd) in Patients With Newly Diagnosed Light Chain (AL) 
      Amyloidosis: 18-month Landmark Analysis of the Phase 3 ANDROMEDA Study 
   -- Pomalidomide and Dexamethasone With or Without Subcutaneous Daratumumab 
      in Patients With Relapsed or Refractory Multiple Myeloma: Updated 
      Analysis of the Phase 3 APOLLO Study 
   -- Subcutaneous Daratumumab with Rapid Corticosteroid Tapering in Relapsed 
      or Refractory Multiple Myeloma Patients: Part 3 Update of the Open-label, 
      Multicenter, Phase 1b PAVO Study 
   -- Progression-free Survival Outcomes by Response Status for Bortezomib, 
      Melphalan, and Prednisone With or Without Daratumumab in Newly Diagnosed 
      Multiple Myeloma: Pooled Subgroup Analysis of OCTANS and ALCYONE 
   -- Daratumumab, Bortezomib, Melphalan, and Prednisone Versus Bortezomib, 
      Melphalan, and Prednisone in Transplant-Ineligible Patients with Newly 
      Diagnosed Multiple Myeloma: Pooled Analysis of OCTANS and ALCYONE 

About Epcoritamab

Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.(i) CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.(ii) (,) (iii) Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' broad oncology collaboration.

About DARZALEX(R) (daratumumab)

DARZALEX(R) (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat certain multiple myeloma indications. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of certain multiple myeloma indications and the first and only approved treatment for certain patients with light-chain (AL) amyloidosis.(iv) (,) (v) (,) (vi)

Please see local country prescribing information for all labeled indication and safety information.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab's vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people's lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab's proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.

Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit and follow us on .


Marisol Peron, Senior Vice President, Global Investor Relations & Communications

T: +1 609 524 0065; E:

For Investor Relations:

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E:

This Media Release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. 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 lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in combination with the HexaBody logo(R) ; DuoHexaBody(R) ; HexElect(R) ; and UniBody(R) .

(i) Engelbert et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020 Feb;52: 102625. doi: 10.1016/j.ebiom.2019.102625. Epub 2020 Jan 23. PMID: 31981978; PMCID: PMC6992935.

(ii) Rafiq, Sarwish, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." Journal of Immunology (Baltimore, Md. 1950), U.S. National Library of Medicine, 15 Mar. 2013,

(iii) Singh, Vijay, et al. "Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." Journal of Cancer Science & Therapy, U.S. National Library of Medicine, Nov. 2015,

(iv) DARZALEX Prescribing information, available at Last accessed July 2021.

(v) DARZALEX Summary of Product Characteristics, available at Last accessed June 2021.

(vi) DARZALEX FASPRO Prescribing information, available at: Last accessed June 2021.

Media Release no. 14

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V



   -- 041121_i14_ASH 2021 

(END) Dow Jones Newswires

November 04, 2021 09:06 ET (13:06 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.

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