MorphoSys and Xencor Complete Enrollment in MOR208 (Xmab5574) Phase 1 Trial in CLL
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MorphoSys AG /
MorphoSys and Xencor Complete Enrollment in MOR208 (Xmab5574) Phase 1 Trial in
CLL
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Study Data Expected in Q4 2012
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and US-based Xencor,
Inc. today announced the successful completion of patient enrollment in the
phase 1 clinical trial evaluating MOR208. MOR208 (formerly XmAb(®)5574) is a
potent anti-CD19 antibody with a proprietary modification to the Fc portion,
that is being developedto treat B-cell malignancies. A total of 30 patients with
relapsed or refractory chronic lymphocytic leukemia (CLL/SLL) have been
randomized in the open-label, multi-dose, single-arm, dose-escalation study. No
dose-limiting toxicity was observed and the trial protocol was amended to
include a period of extended dosing for patients responding to treatment. The
phase 1 trial was designed to assess the drug's safety, tolerability,
pharmacokinetic profile and preliminary anti-tumor activity. Data from the trial
will become available in Q4 2012.
"We are excited about the excellent progress of the MOR208 program and are
preparing the next steps of clinical development in additional B-cell
malignancies to quickly assess the broader commercial potential of the
molecule," commented Dr. Arndt Schottelius, Chief Development Officer of
MorphoSys AG. "The extended treatment period we were able to include in the
phase 1 study could provide us with additional data on preliminary anti-tumor
activity."
"MOR208 uses our XmAb ADCC technology to enhance its B-cell depletion
properties," said Bassil Dahiyat, Ph.D., Chief Executive Officer of Xencor. "The
XmAb high ADCC technology has been applied to develop six antibodies that are
now in clinical testing, demonstrating the technology's broad applicability."
In June 2010, MorphoSys AG and Xencor signed a worldwide exclusive license and
collaboration agreement. The agreement provided MorphoSys with an exclusive
worldwide license to MOR208 for the treatment of cancer and other indications.
Using Xencor's XmAb Fc enhancement technology, MOR208 has been engineered to
possess significantly enhanced antibody-dependent cell-mediated cytotoxicity
(ADCC), thus improving a key mechanism for tumor cell killing and offering
potential for enhanced efficacy compared to traditional antibodies for the
treatment of cancer. MorphoSys will be solely responsible for further clinical
development after successful completion of the phase 1 clinical trial. MorphoSys
plans to initiate additional clinical trials for MOR208 in non-Hodgkin's
lymphoma (NHL) and acute lymphoblastic leukemia (ALL) in the fourth quarter of
2012.
In total, MorphoSys currently has four proprietary clinical programs ongoing,
including MOR208, MOR103, a fully human HuCAL antibody directed against GM-CSF
(granulocyte macrophage-colony stimulating factor), in RA and MS, as well as
MOR202, a HuCAL antibody targeting CD38, in multiple myeloma.
About Xencor, Inc.
Xencor, Inc. engineers superior biotherapeutics using its proprietary Protein
Design Automation(®) technology platform, and is a leader in the field of
antibody engineering to significantly improve antibody half-life, immune-
regulatory function and potency. The company is advancing multiple XmAb(®)
antibody drug candidates in the clinic, including XmAb(®)5871 targeting CD32b
and CD19 for autoimmune diseases, and an anti-CD30 candidate XmAb(®)2513 for the
treatment of Hodgkin's lymphoma. Xencor is also advancing a portfolio of
biosuperior versions of blockbuster antibody drugs engineered for superior half-
life and dosing schedule. Xencor has entered into multiple partnerships with
industry leaders such as Amgen, Pfizer, Centocor, MorphoSys, Boehringer
Ingelheim, CSL Ltd. and Human Genome Sciences. In these partnerships Xencor is
applying its suite of proprietary antibody Fc domains to improve antibody drug
candidates for traits such as sustained half-life and/or potency. More
information is available at www.xencor.com
About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library technology in
the pharmaceutical industry. By successfully applying this and other patented
technologies, MorphoSys has become a leader in the field of therapeutic
antibodies, one of the fastest-growing drug classes in human healthcare. The
company's AbD Serotec unit uses HuCAL and other antibody technologies to
generate superior monoclonal antibodies for research and diagnostic
applications.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic
pipeline of more than 70 human antibody drug candidates for the treatment of
cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With
its ongoing commitment to new antibody technology and drug development,
MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is
listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates
about MorphoSys, visit http://www.morphosys.com
HuCAL(®), HuCAL GOLD(®), HuCAL PLATINUM(®), Ylanthia(®), CysDisplay(®),
RapMAT(®) and arYla(®) are registered trademarks of MorphoSys AG.
XmAb(®) is a registered trademark of Xencor, Inc.
This communication contains certain forward-looking statements concerning the
MorphoSys group of companies. The forward-looking statements contained herein
represent the judgment of MorphoSys as of the date of this release and involve
risks and uncertainties. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ from those anticipated.
MorphoSys does not intend to update any of these forward-looking statements as
far as the wording of the relevant press release is concerned.
For more information, please contact:
MorphoSys AG Media Contact for Xencor:
Dr. Claudia Gutjahr-Löser Heidi Chokeir
Head of Corporate Communications & IR Canale Communications
Tel: +49 (0) 89 / 899 27-122 Tel: 619-849-5377
heidi(at)canalecomm.com
Mario Brkulj
Senior Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-454
Jessica Kulpi
Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-332
investors(at)morphosys.com
Media Release:
http://hugin.info/130295/R/1613540/513850.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: MorphoSys AG via Thomson Reuters ONE
[HUG#1613540]
Unternehmensinformation / Kurzprofil:
Datum: 22.05.2012 - 07:30 Uhr
Sprache: Deutsch
News-ID 148629
Anzahl Zeichen: 7971
contact information:
Town:
Martinsried / München
Kategorie:
Business News
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