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LandDanmark
ListaLarge Cap Copenhagen
SektorHälsovård
IndustriBioteknik
Genmab är ett läkemedelsbolag. Bolaget är specialiserade inom forskning och utveckling av antikroppar, som huvudsakligen används vid behandling av cancerpatienter med lymfatisk leukemi och solida tumörer. Forskning och utveckling utgår ifrån bolagets egenutvecklade tekniska plattform och verksamhet innehas på global nivå. Genmab grundades 1999 och har sitt huvudkontor i Köpenhamn.
2022-11-03 14:01:00

Media Release

Copenhagen, Denmark, November 3, 2022

  • Nineteen abstracts accepted, including multiple presentations on the safety and efficacy of investigational epcoritamab (DuoBody®-CD3xCD20) in a variety of treatment settings and hematologic malignancies
  • Four oral presentations highlighting data evaluating epcoritamab for the treatment of relapsed/refractory (R/R) large B-cell lymphoma (LBCL), R/R follicular lymphoma (FL), previously untreated FL, and Richter's syndrome
  • New data evaluating investigational medicines in Genmab’s early portfolio of cancer immunotherapies will also be presented
  • Genmab to host 2022 R&D Update and ASH Data Review meeting December 12


Genmab A/S (Nasdaq: GMAB) announced today that 19 abstracts evaluating various investigational medicines in its pipeline have been accepted for presentation at the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held at the Ernest N. Morial Convention Center in New Orleans, Louisiana, and virtually, December 10-13. The presentations will include four oral and six poster presentations highlighting data from several clinical trials evaluating the safety and efficacy of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology, alone or in combination for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), previously untreated FL and Richter’s syndrome.

Additionally, abstracts evaluating two investigational medicines in Genmab’s early pipeline have been accepted for presentation, including the first-in-human data from the phase 1/2 trial evaluating GEN3014 (HexaBody®-CD38), an investigational novel human CD38 monoclonal antibody, in patients with R/R multiple myeloma (MM). In addition, preclinical data from a novel drug candidate GEN3017 (DuoBody®-CD3xCD30) will also be presented.

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

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies are committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of B-cell malignancies, including an ongoing phase 3, open-label, randomized clinical trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory LBCL, including DLBCL (NCT: 04628494) and a phase 3, open-label randomized clinical trial evaluating epcoritamab in combination in patients with relapsed/refractory follicular lymphoma (FL) (NCT: 05409066).

“As part of our commitment to the blood cancer community, we continue to advance our research and innovative technologies in an effort to develop differentiated therapies with the goal of transforming the future of treatment for patients,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “The robust data being presented at this year’s American Society of Hematology meeting are encouraging and support the potential of epcoritamab to become a core therapy for B-cell malignancies.”

2022 R&D Update and ASH Data Review
On Monday, December 12, at 8:00 PM EST (7:00 PM CST / 1:00 AM GMT), Genmab will host its 2022 R&D Update and ASH Data Review. The event will be conducted and webcast live. Details, including the webcast link and registration can be found here. This meeting is not an official program of the ASH Annual Meeting.

Abstracts accepted at ASH:

Epcoritamab (DuoBody®-CD3xCD20)

Abstract NumberAbstract TitleType of PresentationDate/Time of Presentation
348Subcutaneous Epcoritamab in Patients with Richter’s Syndrome: Early Results from Phase 1b/2 Trial (EPCORE CLL-1). Kater et. al.OralSaturday, December 10, 4:00 PM - 5:30 PM
443Subcutaneous Epcoritamab + R-DHAX/C in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Eligible for Autologous Stem Cell Transplant: Updated Phase 1/2 Results. Abrisqueta et. al.OralSunday, December 11, 9:30 AM - 11:00 AM
609Subcutaneous Epcoritamab with Rituximab + Lenalidomide in Patients with Relapsed or Refractory Follicular Lymphoma: Phase 1/2 Trial Update. Falchi et. al.OralSunday, December 11, 4:30 PM - 6:00 PM
611Subcutaneous Epcoritamab in Combination with Rituximab + Lenalidomide (R2) for First-Line Treatment of Follicular Lymphoma: Initial Results from Phase 1/2 Trial. Falchi et. al.OralSunday, December 11, 4:30 PM - 6:00 PM
4251Epcoritamab Monotherapy Provides Deep and Durable Responses Including Minimal Residual Disease (MRD) Negativity: Novel Subgroup Analyses in Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL). Phillips et. al.PosterMonday, December 12, 6:00 PM - 8:00 PM
3580Improvements in Lymphoma Symptoms and Health-related Quality of Life in Patients with Relapsed or Refractory Large B-cell Lymphoma Treated with Epcoritamab. Phillips et. al.PosterSunday, December 11, 6:00 PM - 8:00 PM
4912Indirect Comparison of the Efficacy of Subcutaneous Epcoritamab Dose Expansion (EPCORE NHL-1 Trial) in Patients With Relapsed or Refractory Large B-cell Lymphoma. Salles et. al.PosterMonday, December 12, 6:00 PM - 8:00 PM
2874Deep peripheral T cell subset immune-profiling in relapse/refractory non-Hodgkins lymphoma (NHL): Evaluation of baseline samples from the Epcoritamab 3013-01 trial. Blum et. al.PosterSunday, December 11, 6:00 PM - 8:00 PM
2859Transcriptomic Comparison of Non-Hodgkin Lymphomas in Relapsed/Refractory versus Newly Diagnosed Patients with Single Slides. Jabado et. al.PosterSunday, December 11, 6:00 PM - 8:00 PM
1663Phase 1b Trial of Subcutaneous Epcoritamab Among Pediatric Patients With Relapsed or Refractory Aggressive Mature B-Cell Neoplasms. Cairo et. al.PosterSaturday, December 10, 5:30 PM - 7:30 PM
4182Evaluation of Epcoritamab and Rituximab Combination in Preclinical Models of B-cell non-Hodgkin’s Lymphoma (NHL). Epling-Burnette et. al.PosterMonday, December 12, 6:00 PM - 8:00 PM
4206Phase 3 Trial of Subcutaneous Epcoritamab in Combination With Rituximab and Lenalidomide (R2) vs R2 Without Epcoritamab Among Patients With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1). Falchi et. al.PosterMonday, December 12, 6:00 PM - 8:00 PM
4271Phase 2 Trial to Evaluate Safety of Subcutaneous Epcoritamab Monotherapy in the Outpatient Setting Among Patients With Relapsed or Refractory Diffuse Grade 1–3a Large B-Cell and Follicular Lymphoma. Sharman et. al.PosterMonday, December 12, 6:00 PM - 8:00 PM
5524Assessing Safety, Tolerability, and Efficacy of Subcutaneous Epcoritamab in Novel Combinations with Anti-Neoplastic Agents in Patients with Non-Hodgkin Lymphoma in a Phase 1b/2, Open-Label Study. Sehn et. al.PublicationNA

GEN3014 (HexaBody®-CD38)

Abstract NumberAbstract TitleType of PresentationDate/Time of Presentation
3254Preliminary Dose-Escalation Results From a First-in-Human Phase 1/2 Study of GEN3014 (HexaBody®-CD38) in Patients (pts) With Relapsed or Refractory (R/R) Multiple Myeloma (MM). Spencer et. al.PosterSunday, December 11, 6:00-8:00 PM

GEN3017 (DuoBody®-CD3xCD30)

Abstract NumberAbstract TitleType of PresentationDate/Time of Presentation
1366DuoBody®-CD3xCD30 shows potent preclinical anti-tumor activity in vitro in CD30+ hematologic malignancies. Oostindie et. al.PosterSunday, December 11, 6:00 PM - 8:00 PM

Real-World Evidence

Abstract NumberAbstract TitleType of PresentationDate/Time of Presentation

2978
Real-World Outcomes in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Treated with Standard of Care: a COTA Database Analysis. Ip et. al.PosterSunday, December 11, 6:00 PM - 8:00 PM
2296Treatment Patterns and Outcomes in Patients With Follicular Lymphoma Receiving at Least 3 Lines of Therapy: a Real-World Evaluation in the United States. Phillips et. al.PosterSaturday, December 10, 5:30 PM - 7:30 PM
2215Health Care Resource Utilization and Costs of CAR T Therapy in Patients With Large B-Cell Lymphoma: A Retrospective US Claims Database Analysis. Davies et. al.PosterSaturday, December 10, 5:30 PM - 7:30 PM

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 elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.i CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.ii,iii

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 Genmab.com and follow us on Twitter.com/Genmab.

Contact:        
David Freundel, Director, Product Communications
T: +1 609 613 0504; E: dafr@genmab.com

For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Company Announcement 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 www.genmab.com 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 www.sec.gov. 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®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®.


i Engelberts 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;52:102625. DOI: 10.1016/j.ebiom.2019.102625
ii Rafiq, Butchar, Cheney, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." J. Immunol. 2013;190(6):2702-2711. DOI: 10.4049/jimmunol.1202588
iii Singh, Gupta, Almasan. "Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." J Cancer Sci Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373

 

 

Media Release no. 15
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark