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Genmab Announces Daratumumab and Ofatumumab Data to Be Presented at American Society of Hematology Annual Meeting (ASH)

Media Release

  • 10 abstracts on Genmab programs scheduled for presentation at ASH
  • Preliminary data from Phase I and Phase I/II studies of daratumumab in combination with treatment regimens containing bortezomib or various immunomodulatory drugs in multiple myeloma
  • Data from Phase III studies of ofatumumab
  • Pre-clinical data on HuMax(r)-TAC-ADC

COPENHAGEN, Denmark, Nov. 6, 2014 (GLOBE NEWSWIRE) -- Genmab A/S (OMX: GEN) announced today that a total of 10 abstracts for studies of Genmab's and our collaboration partners' programs have been accepted for presentation at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition December 6-9 in San Francisco, California. The abstracts include data on the daratumumab and ofatumumab programs and pre-clinical animal model data with HuMax-TAC-ADC. The abstracts are available on the ASH website at www.hematology.org.

Daratumumab Abstracts to Be Presented

Safety and Efficacy of Daratumumab with Lenalidomide and Dexamethasone in Relapsed or Relapsed, Refractory Multiple Myeloma - Oral presentation Sunday, December 7 from 12 Noon to 1:30PM PST

An Open-label, Multicenter, Phase Ib Study of Daratumumab in Combination with Backbone Regimens in Patients with Multiple Myeloma - Oral presentation Sunday, December 7 from 4:30 to 6:30PM PST

Daratumumab, a novel Anti-CD38 Monoclonal Antibody Shows Anti-tumor Activity in CLL and Hampers Leukemia-microenvironment Interactions - Poster presentation, Monday, December 8 from 6:00 to 8:00PM PST

Direct in Vitro Comparison of Daratumumab with Surrogate Analogs of CD38 Antibodies MOR03087, SAR650984 and Ab79 - Poster presentation, Sunday, December 7 from 6:00 to 8:00PM PST

Anti-leukemic Activity of Daratumumab in Acute Myeloid Leukemia Cells and Patient-Derived Xenografts - Poster presentation, Sunday, December 7 from 6:00 to 8:00PM PST

Modulation of CD38 Expression Levels on Multiple Myeloma Tumor Cells by All-Trans Retinoic Acid Improves the Efficacy of the Anti-CD38 Monoclonal Antibody Daratumumab - Poster presentation, Saturday, December 6 from 5:30 to 7:30 PM PST

Ofatumumab Abstracts to Be Presented

Ofatumumab (OFA) Maintenance Prolongs PFS in Relapsed CLL: PROLONG Study Interim Analysis Results - Oral presentation, Saturday, December 6 from 12 Noon to 1:30PM PST

Ofatumumab (Ofa) vs. Physician's Choice (PC) of Therapy in Patients (pts) with Bulky Fludarabine Refractory (BFR) Chronic Lymphocytic Leukemia (CLL): Results of the Phase III study OMB114242 - Poster presentation, Monday, December 8 from 6:00 to 8:00PM PST

Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: The ORCHARRD study (OMB110928) - Oral presentation, Monday, December 8 from 4:30 to 6:00PM PST

HuMax-TAC-ADC (ADCT-301) Abstract to Be Presented

Pre-clinical Activity of ADCT-301, a Novel Pyrrolobenzodiazepine (PBD) Dimer-Containing Antibody Drug Conjugate (ADC) Targeting CD25-Expressing Hematological Malignancies - Poster presentation, Monday, December 8 from 6:00 to 8:00PM PST

Other Abstracts to Be Presented

CD38 Chimeric Antigen Receptor Engineered T Cells as Tools for Immunotherapy of Multiple Myeloma - Poster presentation, Monday, December 8 from 6:00 to 8:00 PM PST

Enhancing Natural Killer Cell-Mediated Lysis of Lymphoma Cells By Combining Therapeutic Antibodies with CD20-Specific Immunoligands Engaging NKG2D or NKp30 - Poster presentation, Saturday, December 6 from 5:30 to 7:30PM PST

About daratumumab

Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

About ofatumumab

Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops1. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and the GlaxoSmithKline group of companies. Ofatumumab is not licensed anywhere in the world as maintenance therapy in relapsed chronic lymphocytic leukemia (CLL), bulky CLL or relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

About HuMax-TAC-ADC

HuMax-TAC is a high-affinity fully human antibody targeting CD25, a therapeutic target with strong clinical validation. CD25 is expressed on a variety of hematological tumors and shows limited expression on normal tissues, which makes it a very attractive target for antibody-payload approaches. With HuMax-TAC-ADC, we aim to develop a first-in-class antibody-drug conjugate for the potential treatment of CD25-expressing lymphomas and leukemias. HuMax-TAC-ADC is being developed under an agreement between Genmab and ADC Therapeutics.

About Genmab A/S

Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company currently has one marketed antibody, Arzerra(r) (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and daratumumab in late stage clinical development for multiple myeloma. Additionally Genmab has a clinical pipeline with both late and early stage programs, and an innovative pre-clinical pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody(r) platform for generation of bispecific antibodies, and the HexaBody(tm) platform which creates effector function enhanced antibodies. Genmab's deep antibody expertise is expected to provide a stream of future product candidates. Partnering of selected innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.

Contact:

Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communication
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

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 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 . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab(r); the Y-shaped Genmab logo(r); Genmab in combination with the Y-shaped Genmab logo(tm); the DuoBody logo(tm); the HexaBody logo(tm); HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(tm) and UniBody(r). Arzerra(r) is a registered trademark of the GSK group of companies.

[1]Teeling et al, J Immunol 2006; 177:362-371

Media Release no. 06
CVR no. 2102 3884

Genmab A/S
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Source:Genmab A/S