- Updated daratumumab multiple myeloma clinical data to be presented
- ASCO abstracts for daratumumab and ofatumumab available online
- Ofatumumab maintenance data in fludarabine-refractory CLL to be presented
Copenhagen, Denmark; May 17, 2012 – Genmab A/S (OMX: GEN) announced today that clinical data from the ongoing daratumumab Phase I/II study in multiple myeloma will be presented at two upcoming medical conferences. Updated safety and preliminary efficacy data from the study will be presented in an oral session at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago at 10:30AM Central time (CT) on June 4. Abstracts have been published at the ASCO website at www.asco.org/abstracts.
An oral presentation of the daratumumab study data will also be given at the 17th Congress of the European Hematology Association (EHA) in Amsterdam. Abstracts will be published online on May 21 at the EHA website at www.ehaweb.org.
Following the oral presentations, selected slides showing the daratumumab data will be available on Genmab’s website at www.genmab.com/events.
In addition, several other ofatumumab and daratumumab abstracts will be presented at the ASCO and EHA conferences.
Abstracts to Be Presented at ASCO
Daratumumab
Daratumumab – a CD38 mAb – for the Treatment of Relapsed/Refractory Multiple Myeloma Patients: Preliminary Efficacy Data from a Multicenter Phase I/II Study – Abstract #8019 Oral presentation June 4 at 11:45AM CT
Ofatumumab
Ofatumumab retreatment and maintenance in patients with fludarabine-refractory CLL – Abstract #6584 Poster presentation June 4 at 1:15PM CT
Phase II Trial of the Combination of Ofatumumab and Lenalidomide in Patients with Relapsed Chronic Lymphocytic Leukemia (CLL) – Abstract #6516 Poster presentation June 1 at 1:00PM CT
A Phase Ib/II study evaluating activity and tolerability of BTK inhibitor PCI-32765 and ofatumumab in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and related diseases – Abstract #6508 Oral presentation June 4 at 10:30AM CT
A Phase I/II Study of the Selective Phosphatidylinositol 3-Kinase-Delta Inhibitor, GS-1101 (CAL-101), with Ofatumumab in Patients with Previously Treated Chronic Lymphocytic Leukemia (CLL) – Abstract #6518 Poster presentation June 1 at 1:00PM CT
Abstracts to Be Presented at EHA
Daratumumab
Daratumumab, a CD38 Monoclonal Antibody in Patients with Multiple Myeloma - Preliminary Efficacy and Pharmacokinetics Data from a Dose-Escalation Phase I/II Study (oral presentation)
Reconstructing the Human Hematopoietic Niche: Opportunities for Studying Normal and Malignant Hematopoiesis
Towards Personalized Medicine Using a Novel Preclinical Model: Identifying Daratumumab as Effective Treatment for Multiple Myeloma
See the EHA website for further details on timing of presentations: 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 ofatumumab
Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20 molecule encompassing parts of the small and large extracellular loops (Teeling et al 2006). Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
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 press 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 press 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.
Investor News no. 01
CVR no. 2102 3884
Genmab A/S
Bredgade 34
1260 Copenhagen K
Denmark
