Medarex Announces Enhanced Activity Data with Second Generation Anti-CD30 Antibody for Malignant Lymphoma
Presentation at the 50th Annual Meeting of the American Society of Hematology
PRINCETON, N.J., Dec. 8 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq:
MEDX) announced today results from a preclinical study for MDX-1401, a
second-generation non-fucosylated version of MDX-060 that targets CD30, a
marker for activated lymphocytes that is present on the malignant cells of
Hodgkin's lymphoma (HL) as well as other CD30-expressing cancers. MDX-1401
demonstrated almost a doubling in potency and efficacy in cell lines when
compared to MDX-060. The improved potency and efficacy of MDX-1401 in in vivo
xenograft models indicates enhanced antibody-dependent cellular cytotoxicity
(ADCC) activity, an important mechanism of action of therapeutic antibodies.
In addition to anti-tumor activity, the preclinical data showed a
statistically significant increase in median survival time for the MDX-1401
treatment group when compared to the MDX-060 treatment group.
The data were presented in a poster presentation entitled
"Characterization of MDX-1401, a human anti-CD30 antibody with enhanced
effector function, for therapy of malignant lymphoma" (abstract #1580) at the
50th Annual Meeting of the American Society of Hematology (ASH) being held
December 6-9, 2008 in San Francisco, CA.
"We are excited with the growing body of scientific evidence that
indicates enhanced ADCC and improved anti-tumor efficacy with the second
generation anti-CD30 antibody, MDX-1401, as compared to MDX-060," said
Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at
Medarex. "The data we have seen to date continues to inform our development
plans and underscores the importance of assessing MDX-1401 as a potentially
more potent therapeutic for CD-30 expressing malignancies. We look forward to
presenting results from the ongoing Phase 1 MDX-1401 study and the recently
completed Phase 2 MDX-060 study in 2009."
More information about the ASH Annual Meeting may be found at
www.hematology.org
About MDX-1401
MDX-1401 is a non-fucosylated version of the MDX-060 antibody and is
enhanced for greater antibody-dependent cellular cytotoxicity (ADCC) activity,
an important function of the human immune system, whereby immune cells can
kill target cells. ADCC activity is one important mechanism underlying the
efficacy of some currently approved anti-cancer antibodies. A dose-escalation,
multi-dose Phase 1 clinical trial of MDX-1401 in up to 36 patients with
relapsed or refractory Hodgkin's lymphoma (HL) is currently ongoing, with
results expected in 2009. The trial is designed to establish and evaluate the
safety profile and initial efficacy of the antibody.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize a
broad range of fully human antibody product candidates for itself and its
partners. Over forty of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with the most advanced product candidates currently in Phase
3 clinical trials or the subject of regulatory applications for marketing
authorization. Medarex is committed to building value by developing a diverse
pipeline of antibody products to address the world's unmet healthcare needs.
For more information about Medarex, visit its website at www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, the statements
relating to MDX-1401 in this press release may constitute forward-looking
statements, as defined in the Private Securities Litigation Reform Act of
1995, that are subject to certain risks and uncertainties that could cause
actual results to differ materially from any future results, performance or
achievements expressed or implied by such statements. Medarex disclaims,
however, any intent or obligation to update these forward-looking statements.
Risks and uncertainties include risks associated with product discovery and
development of MDX-1401, as well as risks detailed from time to time in
Medarex's public disclosure filings with the U.S. Securities and Exchange
Commission (SEC), including its Annual Report on Form 10-K for the fiscal year
ended December 31, 2007 and its quarterly reports on Form 10-Q. Copies of
Medarex's public disclosure filings are available from its investor relations
department.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of
Medarex, Inc. All rights are reserved.