MARTINSRIED, Germany and
MUNICH and MONROVIA, Calif., Nov.
5, 2012 /PRNewswire/ -- 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.
SOURCE Xencor; MorphoSys