Media Release
- Four daratumumab and two ofatumumab abstracts to be presented at EHA
- Abstracts available online at EHA website
Copenhagen, Denmark; May 22, 2014 – Genmab A/S (OMX: GEN) announced today that data from two ongoing studies of daratumumab, in addition to pre-clinical data, will be presented at the 19th Congress of the European Hematology Association (EHA) in Milan Italy, June 12-15. Data from the Phase I/II study of daratumumab as a monotherapy to treat patients with relapsed or refractory multiple myeloma as well as results from the Phase I/II study of daratumumab in combination with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma will be presented in poster sessions. These data are also being presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago May 30 – June 3. The abstracts are available at the EHA website at www.ehaweb.org.
Abstracts
Safety and efficacy of daratumumab with lenalidomide and dexamethasone in relapsed or relapsed, refractory multiple myeloma – Poster presentation June 13 from 5:45 to 7:00 PM CEST
Dose-dependent efficacy of daratumumab (dara) as monotherapy in patients with relapsed or refractory multiple myeloma (RR MM) – Poster presentation June 13 from 5:45 to 7:00 PM CEST
Daratumumab treatment alone or in combination with vincristine results in the inhibition of tumor growth and long term survival in preclinical models of acute lymphocytic leukemia – Poster presentation June 13 from 5:45 to 7:00 PM CEST
Daratumumab treatment in combination with CHOP or R-CHOP results in the inhibition or regression of tumors in preclinical models of non-Hodgkin’s lymphoma – Poster presentation June 13 from 5:45 to 7:00 PM CEST
SF3B1 mutations and outcome in CLL patients treated with chlorambucil (CHL) or ofatumumab-CHL (O+CHL): Results from the Phase III study COMPLEMENT 1 (OMB110911) – Oral presentation June 15 from 11:30 to 11:45 AM CEST
Ibrutinib interferes with the cell-mediated anti-tumour activities of therapeutic CD20 antibodies: implications for combination therapy – Oral presentation June 15 from 11:00 to 11:15 AM CEST
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 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 loops. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and the GlaxoSmithKline group of companies.
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® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications, 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® platform for generation of bispecific antibodies, and the HexaBody™ 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®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo™; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody™ and UniBody®. Arzerra® is a registered trademark of the GSK group of companies.
Media Release no. 03
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
