MorphoSys and Xencor Provide Update on Phase 1/2a Trial in CLL/SLL for MOR208 (Xmab5574)
(Thomson Reuters ONE) -
MorphoSys AG /
MorphoSys and Xencor Provide Update on Phase 1/2a Trial in CLL/SLL for MOR208
(Xmab5574)
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The issuer is solely responsible for the content of this announcement.
Extended Treatment Resulted in Higher Overall Response Rate
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) and US-based
Xencor, Inc. today announced completion of the phase 1/2a clinical trial
evaluating MOR208 (formerly XmAb(®)5574) in patients with relapsed or refractory
chronic lymphocytic leukemia (CLL/SLL). Safety and objective response data
following the protocol defined 8-week treatment period was presented at the
American Society of Hematology Annual Meeting in December 2012. Due to signs of
activity of MOR208 in this difficult to treat patient population, the study
protocol was amended to allow those patients in the highest dose group
benefitting from the treatment to enter a prolonged treatment group. The final
study results including the extended treatment arm showed an overall response
rate of 29.6% (according to IWCLL 2008 criteria) based on the safety population
of the trial (n=27) - up from the previously reported 14.8%. A detailed analysis
of the study results will be published in a peer-reviewed scientific journal.
"We are very pleased with the outcome of the study including the cases of
improved objective response in the extended treatment arm which underscores the
excellent prospects of MOR208. The final data from this trial clearly
demonstrate the drug's potential in chronic lymphocytic leukemia. MorphoSys is
currently evaluating MOR208 in phase 2 clinical trials for NHL and B-ALL. An
additional phase 2 combination study for MOR208 in chronic lymphocytic leukemia
is an option we are looking at, too," commented Dr. Arndt Schottelius, Chief
Development Officer of MorphoSys AG.
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. Clinical responses were assessed according to International Working
Group on CLL (IWCLL) Guidelines. Eight patients qualified for the extended
treatment group and received up to four additional treatment cycles with MOR208
including prolonged additional disease response assessments.
"The overall response rate of MOR208 demonstrates the drug's potential as a
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.
"The favorable safety profile of the antibody is another beneficial aspect,
especially in heavily pre-treated patient population."
"The promising response rate of MOR208 in a relapsed or refractory patient group
demonstrates the positive impact Fc engineering had on the antibody's activity
against tumors. Currently, MOR208 is the most advanced of four programs
Xencor's partners have in clinical development in oncology," commented Bassil
Dahiyat, Ph.D., Chief Executive Officer of Xencor.
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. After the successful completion of the phase 1/2a study in
CLL MorphoSys is now solely responsible for further clinical development.
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.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic
pipeline of more than 80 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(®), CysDisplay(®), RapMAT(®), arYla(®),
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.
About Xencor, Inc.:
Xencor is developing engineered monoclonal antibodies for the treatment of
autoimmune diseases, asthma and allergic diseases, and cancer. Currently five
antibodies are in clinical development internally and with partners that have
been engineered with Xencor's XmAb technology. Xencor's internally-discovered
programs include XmAb5871, in Phase 2a for the treatment of Rheumatoid arthritis
and lupus, XmAb7195 in preclinical development for the treatment of asthma, and
XmAb5574/MOR208 which has been licensed to MorphoSys AG and is in Phase 2
clinical trials for the treatment of acute lymphoblastic leukemia and non-
Hodgkin lymphoma. Xencor's XmAb antibody engineering technology enables small
changes to the structure of monoclonal antibodies resulting in new mechanisms of
therapeutic action. Xencor partners include Amgen, Merck, Janssen R&D LLC and
Boehringer Ingelheim. For more information, please visit http://www.xencor.com.
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 Xencor, Inc.
Dr. Claudia Gutjahr-Löser Jason Spark
Head of Corporate Communications & IR Canale Communications for Xencor
Tel: +49 (0) 89 / 899 27-122 jason(at)canalecomm.com
(619)849-6005
Mario Brkulj
Associate Director 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
Media Release (PDF):
http://hugin.info/130295/R/1733721/580542.pdf
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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#1733721]
Unternehmensinformation / Kurzprofil:
Datum: 07.10.2013 - 07:31 Uhr
Sprache: Deutsch
News-ID 303149
Anzahl Zeichen: 8914
contact information:
Town:
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Kategorie:
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