Media Release
- Oral presentation to take place June 17 10.45-11am CEST in the Main Auditorium at the EHA congress in Amsterdam
- New Pharmacokinetics (PK) data presented
- Three additional daratumumab presentations
Copenhagen, Denmark; June 14 2012 – Genmab A/S (OMX: GEN) announced today the timing of the oral presentation of preliminary data from the ongoing daratumumab Phase I/II study in multiple myeloma at the 17th Congress of the European Hematology Association (EHA) in Amsterdam, June 14-17 2012.
The presentation details are as follows:
Title: Daratumumab, A CD38 monoclonal antibody in patients with multiple myeloma – Preliminary efficacy and pharmacokinetics data from a dose-escalation phase I/II study
Date: Sunday June 17 2012
Time: 10.45-11am CEST
Presenter: Dr. Henk Lokhorst, University Medical Center Utrecht, Utrecht, The Netherlands
The abstract is available on the EHA website: https://www.eventure-online.com/eventure/publicAbstractView.do?id=193081&congressId=5650
Slides from the presentation will be made available on Genmab’s homepage after the presentation, at the following link www.genmab.com
The oral presentation covers preliminary safety and efficacy data from the ongoing Phase I/II study and includes new pharmacokinetics (PK) data which shows how the antibody is absorbed and distributed in the body of patients. The PK data showed that at therapeutic dose levels a higher degree of responses were seen, with most patients exhibiting a significant reduction in key disease biomarker levels (which include serum M-component, urine M-component and serum free light chains, measured according to the International Myeloma Working Group (IMWG) guidelines) showing that the antibody is clinically active in heavily pre-treated multiple myeloma patients.
In addition, daratumumab data will be highlighted today at 5.25pm CEST in the satellite symposium, entitled “Achieving and maintaining disease control in multiple myeloma”, in a presentation by Dr. Xavier Leleu, entitled ‘Future therapeutic options on the horizon for multiple myeloma’, and in two further daratumumab poster presentations at EHA.
Poster presentations
June 15, 2012 at 5.45-7pm CEST: Reconstructing the Human Hematopoietic Niche: Opportunities for Studying Normal and Malignant Hematopoiesis.
Abstract: https://www.eventure-online.com/eventure/publicAbstractView.do?id=194581&congressId=5650
June 16 5.45-7pm CEST: Towards Personalized medicine using a novel preclinical model: Identifying daratumumab as effective treatment for Multiple Myeloma.
Abstract: https://www.eventure-online.com/eventure/publicAbstractView.do?id=194208&congressId=5650
See the EHA website for further details on the Congress www.ehaweb.org
About daratumumab
Daratumumab, a human CD38 monoclonal antibody with broad-spectrum killing activity, is in clinical development for multiple myeloma. The CD38 molecule is highly expressed on the surface of multiple myeloma cells. Daratumumab could also have potential in other hematological tumors on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
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’s first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of 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®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD20®; HuMax®-EGFr; HuMax®-IL8; HuMax®-TAC; HuMax®-CD38; HuMax®-TF; HuMax®-TF-ADC; HuMax®-Her2; HuMax®-cMet, HuMax®-CD74, DuoBody™ and UniBody® are all trademarks of Genmab A/S. Arzerra® is a trademark of GlaxoSmithKline.
Media Release no. 04
CVR no. 2102 3884
Genmab A/S
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