Genmab Announces Multiple Abstracts to be Presented at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH)

Rhea-AI Summary

Genmab A/S (GMAB) announced several abstract presentations at the 63rd Annual ASH Meeting, showcasing the efficacy of epcoritamab (DuoBody®-CD3xCD20) for treating B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Over 20 abstracts from Genmab and its partners, including AbbVie (ABBV) and Janssen, will be shared, highlighting clinical trial results. A virtual R&D Update and ASH Data Review is scheduled for December 14, focusing on these advancements in oncology.

Positive

• Epcoritamab's preliminary efficacy data for B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia presented at ASH, indicating strong clinical potential.
• More than 20 abstracts accepted for presentation, illustrating a robust pipeline and ongoing collaboration with AbbVie and Janssen.

Negative

• None.

• Poster presentations highlighting safety and preliminary efficacy data of epcoritamab (DuoBody®-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 (CLL)
• 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

COPENHAGEN, Denmark--(BUSINESS WIRE)-- 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™ NHL-2 clinical trial evaluating the safety and preliminary efficacy of epcoritamab (DuoBody®-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™ 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, www.genmab.com. 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 (DLBCL)

Daratumumab:

• 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^® (daratumumab)

DARZALEX^® (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 Genmab.com and follow us on Twitter.com/Genmab.

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 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^®.

iEngelbert 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.

iiRafiq, 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, www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/.

iiiSingh, 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, www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/.

ivDARZALEX Prescribing information, available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761036 Last accessed July 2021.

vDARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 2021.

viDARZALEX FASPRO Prescribing information, available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145 Last accessed June 2021.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211104005293/en/

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

T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com

Source: Genmab A/S

FAQ

What data will Genmab present at the ASH meeting?

Genmab will present safety and preliminary efficacy data of epcoritamab for B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia.

What is the significance of the ASH meeting for Genmab?

The ASH meeting is significant as it showcases over 20 abstracts from Genmab's pipeline, highlighting collaborations and advancements in cancer treatment.

When is Genmab's virtual R&D Update meeting?

Genmab's virtual R&D Update and ASH Data Review is scheduled for December 14 at 2:00 PM EST.

Which companies are collaborating with Genmab on epcoritamab?

Genmab is co-developing epcoritamab with AbbVie and collaborating with Janssen on related bispecific programs.