Summary: Genmab will present Phase II non-cutaneous T-cell lymphoma zanolimumab
data and pre-clinical ofatumumab data on at the 2007 Annual Meeting of the
American Society of Hematology in December.
Copenhagen, Denmark; November 9, 2007 - Genmab A/S (OMX: GEN) announced today it
will present clinical data from the zanolimumab (HuMax-CD4®) Phase II study in
non-cutaneous T-cell lymphoma (NCTCL) and pre-clinical data on ofatumumab's
(HuMax-CD20®) mechanisms of action in poster sessions at the 2007 Annual Meeting
of the American Society of Hematology December 8-11 in Atlanta, Georgia, USA.
Zanolimumab data
Additional positive results have been obtained in the Phase II study to treat
patients with relapsed or refractory NCTCL. A total of 21 patients were
enrolled in the study and received 980 mg of zanolimumab once weekly for 12
weeks. Objective tumor response was obtained in 5 of 21 patients (24%). Three
patients obtained partial responses lasting 43 and 51 days with one patient not
relapsing at 182 days. Two patients obtained a complete response unconfirmed,
one lasting 46 days and one showing no relapse after 252 days. During the study
period, a total of 6 serious adverse events were assessed as related to
zanolimumab treatment and included 4 infusion related events. The patients with
related serious adverse events completely recovered.
Ofatumumab data
In a pre-clinical study, ofatumumab appeared to be more effective than rituximab
in treating chemotherapy refractory diffuse large B-cell lymphoma (DLBCL).
Ofatumumab was significantly more effective in inducing the immune system
killing mechanism complement dependent cytotoxicity (CDC) in 9 of 10 DLBCL tumor
samples when compared to rituximab. In addition, the dose of ofatumumab
required to kill the patients' tumor cells was lower than that required for
rituximab.
In an additional pre-clinical study, B-cells incubated with cholesterol
depleting agents called statins were found to be killed less effectively by CD20
monoclonal antibodies. Importantly, cell lysis of statin-treated B-cells was
consistently higher when using ofatumumab in comparison to rituximab. Statin
incubation was shown to induce conformational changes in the CD20 target and
impaired the binding of ofatumumab and rituximab to the CD20 molecule.
Previously reported data illustrating that ofatumumab appears to induce CDC of
target cells far more rapidly and effectively than rituximab will also be
presented at the ASH conference.
Ofatumumab is an investigational, fully human, next generation monoclonal
antibody that targets a unique epitope of the CD20 receptor on the surface of
B-cells. This epitope is different to the other anti-CD20 antibodies currently
available or in development. Ofatumumab is being developed under a
co-development and commercialization agreement between Genmab and
GlaxoSmithKline.
“We are pleased to present this new information on zanolimumab and ofatumumab at
the ASH conference,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of
Genmab. “The response rate in the zanolimumab trial for NCTCL is encouraging
and we look forward to investigating zanolimumab in combination with other
therapies for NCTCL.”
ASH Poster Sessions
Poster 628 - Zanolimumab (HuMax-CD4), a Fully Human Monoclonal Antibody:
Efficacy and Safety in Patients with Relapsed or Treatment-Refractory
Non-Cutaneous CD4+ T-cell Lymphoma
Poster 536 - Chemotherapy-Refractory Diffuse Large B-Cell Lymphomas (DLBCL) Are
Effectively Killed by Ofatumumab-Induced Complement-Mediated Cytoxicity
Poster 531 - Statins Impair Antitumor Effects of CD20 mAb by Inducing
Conformational Changes of CD20
Poster 1499 - Spinning Disk Confocal Fluorescent Microscopy (SDCFM) Analyses of
Complement Activation Promoted by Anti-CD20 Monoclonal Antibodies (mAbs)
Rituximab and Ofatumumab
Poster 1506 - Complement Activation and Complement-Mediated Killing of B Cells
Promoted by Anti-CD20 Monoclonal Antibodies (mAb) Rituximab and Ofatumumab Are
Rapid, and Ofatumumab Kills Cells More Rapidly and with Greater Efficacy
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for unmet medical needs. Using unique,
cutting-edge antibody technology, Genmab's world class discovery and development
teams have created and developed an extensive pipeline of products for potential
treatment of a variety of diseases including cancer and autoimmune disorders.
As Genmab advances towards a commercial future, we remain committed to our
primary goal of improving the lives of patients who are in urgent need of new
treatment options. For more information on Genmab's products and technology,
visit www.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 product discovery
and development, 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. Genmab is
not under an obligation to up-date statements regarding the future following the
publication of this release; nor to confirm such statements in relation to
actual results, unless this is required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-CD20(R);
HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
and UniBody(R) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45 33 44 77 30, M:
+45 25 27 47 13, E: hth@genmab.com
Stock Exchange Release no. 52/2007
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