MorphoSys and Xencor Report Clinical Data for MOR208/XmAb5574
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MorphoSys and Xencor Report Clinical Data for MOR208/XmAb5574
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Phase 1/2a Trial in CLL/SLL Patients Met Primary and Secondary Objectives
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and US-based Xencor,
Inc. today announced the online publication of first clinical data on the anti-
CD19 antibody MOR208 (MOR00208/XmAb5574) in the American Society of Hematology
Annual Meeting Abstracts issue of the peer-reviewed medical journal Blood.
MOR208 showed encouraging signs of preliminary anti-tumor activity and an
acceptable safety and tolerability profile in patients with high-risk, heavily
pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL). The data support further development of the compound. Based on these
results, MorphoSys plans to commence phase 2 studies of MOR208 in B-cell
malignancies in the near future.
"We are very pleased with the data which justify advancing into phase 2
development in B-cell malignancies," commented Dr. Arndt Schottelius, Chief
Development Officer of MorphoSys AG. "Given that the participants in the trial
had received a median of four prior therapies, the overall response rate that we
observed is very encouraging. In addition, the favorable toxicity profile will
potentially allow combinations with other active agents. The results of the
phase 1/2a study show us that we are on the right track with our most advanced
proprietary compound in cancer."
The phase 1/2a trial was designed to assess the drug's safety, tolerability,
pharmacokinetic profile and preliminary anti-tumor activity. MOR208 was
administered as an intravenous infusion on days 1, 4, 8, 15, and 22 of cycle 1,
and on days 1, 8, 15, and 22 of cycle 2. Dose levels tested ranged from 0.3 to
12 mg/kg. Among the 27 evaluable patients, three partial responses were observed
at the 6, 9, and 12 mg/kg dose levels. In addition, 22 patients experienced
stable disease and only two patients progressed at the 8 week evaluation point.
Clinical responses were assessed according to International Working Group on CLL
(IWCLL) 2008 and 1996 Guidelines. Overall response rate by IWCLL 2008 criteria
was 11% which utilizes more rigorous CT scan reduction of internal lymph nodes
not previously required in older historic studies. Using IWCLL 1996 response
criteria resulted in a response rate of 42%. The most common adverse events were
mild to moderate infusion reactions usually with the first dose. Treatment-
related adverse events classified as grade 3 or higher occurred in 5 out of 27
patients. Only one dose-limiting toxicity was observed in 16 patients treated at
the 12 mg/kg dose level and the trial protocol was amended to include a period
of extended dosing with a total of 8 patients at this dose.
"MOR208 was safe and well-tolerated in this first-in-human study, and shows
promise as an novel immunotherapy for B-cell malignancies", commented the
principal investigator of the study John C. Byrd, MD, Professor and D Warren
Brown Chair of Leukemia Research at The James Cancer Hospital and Solove
Research Institute. "We are really looking forward to incorporating this
together with other active immune and targeted therapies used for CLL in the
near future."
Final phase 1/2a data will be presented at the 2012 American Society of
Hematology (ASH) annual meeting from December 8-11, 2012 in Atlanta.
"MOR208 is now well positioned to advance in development into additional B-cell
malignancies," said Bassil Dahiyat, Ph.D., Chief Executive Officer of Xencor.
"The combination of tolerability and anti-tumor activity add to the growing body
of clinical data on our XmAb(®) technology for enhancing antibody cytotoxic
potency."
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 1/2a clinical trial.
MorphoSys plans to initiate additional clinical trials for MOR208 in non-
Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL) by year-end.
The full abstract is available on
https://ash.confex.com/ash/2012/webprogram/start.html
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
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
HuCAL(®), HuCAL GOLD(®), HuCAL PLATINUM(®), CysDisplay(®), RapMAT(®), arYla(®)
and Ylanthia(®) and 100 billion high potentials(®) are registered trademarks of
MorphoSys AG.
Slonomics(®) is a registered trademark of Sloning BioTechnology GmbH, a
subsidiary 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
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-122
Mario Brkulj
Senior Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-454
Alexandra Goller
Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-332
investors(at)morphosys.com
Xencor, Inc.
Heidi Chokeir, Ph.D.
Canale Communications for Xencor
heidi(at)canalecomm.com
(619)849-5377
Media Release (PDF):
http://hugin.info/130295/R/1655039/534761.pdf
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other applicable laws; and
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originality of the information contained therein.
Source: MorphoSys AG via Thomson Reuters ONE
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