Company Announcement
- Six Genmab abstracts accepted for presentation at ASH
- First preliminary data from Phase I/II daratumumab combination study in multiple myeloma
- Data from Phase III study of ofatumumab (COMPLEMENT 1)
Copenhagen, Denmark; November 7, 2013 – Genmab A/S (OMX: GEN) announced today that six Genmab abstracts which include data on daratumumab, ofatumumab and the novel HexaBody™ technology have been accepted for presentation at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition December 7-11 in New Orleans, Louisiana. The abstracts are available on the ASH website at www.hematology.org.
Daratumumab Combination Data
Preliminary safety and efficacy data from a dose-escalation Phase I/II study of daratumumab in combination with lenalidomide and dexamethasone (Len Dex) in relapsed or refractory multiple myeloma will be presented at the ASH meeting. Six patients are reported in the abstract for this ongoing study. Preliminary data show a manageable safety profile and that daratumumab in combination with Len Dex induced partial responses or better in all six patients. Available data will be updated and presented at the ASH meeting.
List of All Abstracts to Be Presented
Daratumumab
Preliminary Safety and Efficacy Data of Daratumumab in Combination with Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma – (as above) Poster presentation Saturday, December 7 at 5:30PM CST
CD38-Targeted Immunochemotherapy of Multiple Myeloma: Preclinical Evidence for its Combinatorial Use in Lenalidomide and Bortezomib Refractory/Intolerant MM Patients – Oral presentation Monday, December 9 at 7AM CST
Daratumumab, a Novel Human Anti-CD38 Monoclonal Antibody, Shows Anti-tumor Activity in Mouse Models of MCL, FL and CLL – Oral presentation Monday, December 9 at 11:45AM CST
Ofatumumab
Ofatumumab + Chlorambucil Versus Chlorambucil Alone in Patients with Untreated Chronic Lymphocytic Leukemia (CLL): Results of the Phase III Study COMPLEMENT 1 (OMB110911) – Oral presentation Monday, December 9 in Session 642 at 2:45 - 4:15PM CST
NOTCH1 Mutation and Treatment Outcome in CLL Patients Treated with Chlorambucil or Ofatumumab-Chlorambucil: Results from the Phase III Study COMPLEMENT 1 (OMB110911) – Oral presentation Monday, December 9 in Session 642 at 2:45 – 4:15PM CST
In addition to these ofatumumab abstracts, multiple abstracts for Investigator Sponsored Studies (ISS) have also been accepted for presentation at ASH.
HexaBody technology
Enhanced IgG Hexamerization Mediates Efficient C1q Docking and CDC; Preclinical Proof of Concept on Primary CLL and Burkitt Lymphoma – Oral presentation Monday, December 9 at 11AM CST
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. 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 loops1. Ofatumumab has been granted Breakthrough Therapy Designation from the US FDA. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and the GlaxoSmithKline group of companies.
About HexaBody™ technology
HexaBody technology, a broadly applicable antibody platform from Genmab, allows for the creation of potent therapeutics by inducing antibody hexamer formation (clusters of six antibodies). The HexaBody platform builds on natural antibody biology and enhances complement-mediated killing (complement-dependent cytotoxicity (CDC)), allowing antibodies with limited or absent CDC to be transformed into potent, cytotoxic antibodies. The HexaBody technology creates opportunities to explore new product candidates, to repurpose drug candidates unsuccessful in previous clinical trials due to insufficient potency and may provide a useful strategy in product life cycle extension. The HexaBody technology can be directed to any antigen or target, including those implicated in cancer and infectious diseases. The HexaBody technology can be combined with Genmab’s DuoBody® platform as well as other antibody technologies.
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 & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
This Company Announcement 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 Company Announcement 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 logoTM; the DuoBody™ logo; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a registered trademark of GlaxoSmithKline.
[1] Teeling et al, J Immunol 2006; 177:362-371
Company Announcement no. 47
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
