Copenhagen, Denmark; November 5, 2003 – Genmab A/S (CSE: GEN) announced today that it will make presentations about both HuMax-CD4 and HuMax-CD20 at the 45th Annual Meeting of American Society of Hematology. The first presentation will be an interim analysis of two ongoing Phase II HuMax-CD4 studies to treat cutaneous T-cell lymphoma (CTCL). The two studies encompass both early and late stage CTCL patients, with 11 early stage patients and 13 late stage patients enrolled in total. 

Preliminary results indicate a favorable response to HuMax-CD4 and it has also been safe and well tolerated in these trials to date.

Based on this encouraging preliminary analysis, Genmab has begun enrolling additional patients in both studies and increased the weekly dose from 280mg to 560mg for early stage patients and from 280mg to 980mg for patients with late stage disease.  Treatment of these additional patients will continue for up to 16 weeks. The studies involving the original 24 patients also continue and a number of them have not received their entire course of therapy. 

On behalf of Genmab, Dr. Jan van de Winkel, Chief Scientific Officer, will make an oral presentation of new pre-clinical data on HuMax-CD20 focused on further research into its novelty and mechanism of action. In previous studies, HuMax-CD20 was far more effective than rituximab in eradicating B-cell tumors in SCID mouse models, as well as in depleting B- cells from peripheral blood and lymph nodes in Cynomolgus monkeys.

“HuMax-CD4, a Fully Human Monoclonal Antibody: Early Results of an Ongoing Phase II Trial in Cutaneous T-Cell Lymphoma” will be presented on Sunday, December 7 at 5:45PM in Halls D and E. “Novel Fully Human CD20 Antibodies with Different Mechanisms of Action” will be presented on Monday, December 8 from 11AM to 12:30PM in the session entitled “Clinicopathologic and Molecular Factors Impacting Prognosis” in Room 29. Full text of the abstracts are available at http://www.hematology.org/meeting/abstracts.cfm.

“This preliminary HuMax-CD4 data is encouraging and I look forward to the interim analysis as well as the new HuMax-CD20 data” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. 

Conference Call

Genmab’s Management will be happy to answer questions regarding this release during the already scheduled conference call regarding the third quarter financial results today, Wednesday, November 5, at

6:00 pm CET

5:00 pm BST

12:00 pm US Eastern Time

The dial in numbers are as follows:

+1-800-915-4836 (in the US) and ask for the Genmab conference call

+1-973-317-5319 (outside the US) and ask for the Genmab conference call

About the HuMax-CD4 studies

Genmab is running two Phase II studies concurrently. One study is focused on early stage and the other is for patients with late stage disease in patients with persistent CTCL, refractory or intolerant to previous therapy. In both studies, the treatment regimen involves a 280 mg dose of HuMax-CD4 once a week for 16 weeks. Patients are followed for at least four weeks after the end of treatment or until disease progression.  The objective of the studies is to determine the efficacy and safety of HuMax-CD4 in the treatment of CTCL.

About T-cell lymphomas and CTCL

T-cell lymphomas positive for the CD4 receptor constitute around 5% of Non Hodgkin’s Lymphomas.

CTCL is one group of CD4+ lymphomas. This type of lymphoma expresses the CD4 receptor which can be targeted by Genmab’s HuMax-CD4 antibody. CTCL is a highly symptomatic disfiguring disease which is life threatening in the advanced stages and is incurable except at its very earliest stages.

CTCL patients tend to have a lifespan of 10 to 30 years and therefore could be treated several times during the disease progression. CTCL covers a range of diseases characterized by infiltration of the skin by malignant T-cells. This range of diseases includes Mycosis fungoides and the Sezary syndrome. Mycosis fungoides represents around 70% of all CTCLs.  Most patients show symptoms even at the earliest stage of the disease with itching and susceptibility to recurrent skin infections, and the majority suffer moderate to severe cosmetic disfigurement. In several groups of CTCL patients, defective apoptosis (or programmed cell death) has been documented, which may contribute to the difficulty of killing these types of tumors. An anti-CD4 antibody that depletes CD4+ cells in vivo has the potential to induce a clinical response.

There are about 1,000 new cases of CTCL per year in the US and the prevalence of the disease is estimated at 16,000 to 20,000.

About HuMax-CD20

HuMax-CD20 is a human antibody which is effective at binding to the disease target, and releases only very slowly from the target over time. In February 2003, Genmab presented data from pre-clinical laboratory tests showing HuMax-CD20 appeared to kill tumor cells that were resistant to rituximab.  The data showed the antibody was highly effective in inducing complement mediated cytotoxicity (cell destruction) of B-cell tumors. Subsequently, Genmab has collected data that appears to show Humax-CD20 is also effective in inducing Natural Killer cell-mediated cytotoxicity of B-cell tumors.

About CD20

The CD20 antigen is a transmembrane protein on pre-B and mature B lymphocytes. CD20 appears to act as a calcium ion channel, and to regulate early steps in B lymphocyte activation. The molecule is not shed from the cell surface, and is not internalized upon antibody binding. CD20 is found on over 90% of B-cell lymphomas, as well as other lymphoid tumors of B-cell origin.