Home » Business News » 2012 » November » November 5, 2012

MorphoSys and Xencor Report Clinical Data for MOR208/XmAb5574

November 5, 2012 - Munich, Germany

MorphoSys AG /MorphoSys and Xencor Report Clinical Data for MOR208/XmAb5574. Processedand transmitted by Thomson Reuters ONE.

The issuer is solely responsible for the content of this announcement.

Phase 1/2a Trial in CLL/SLL Patients Met Primary and Secondary Objectives

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and US-basedXencor,Inc. today announced the online publication of first clinical data on theanti-CD19 antibody MOR208 (MOR00208/XmAb5574) in the American Society ofHematologyAnnual Meeting Abstracts issue of the peer-reviewed medical journal Blood.MOR208 showed encouraging signs of preliminary anti-tumor activity and anacceptable safety and tolerability profile in patients with high-risk,heavilypretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma(SLL). The data support further development of the compound. Based on theseresults, MorphoSys plans to commence phase 2 studies of MOR208 in B-cellmalignancies in the near future.

"We are very pleased with the data which justify advancing intophase 2development in B-cell malignancies," commented Dr. Arndt Schottelius,ChiefDevelopment Officer of MorphoSys AG. "Given that the participants in thetrialhad received a median of four prior therapies, the overall response ratethat weobserved is very encouraging. In addition, the favorable toxicity profilewillpotentially allow combinations with other active agents. The resultsof thephase 1/2a study show us that we are on the right track with our mostadvancedproprietary compound in cancer."

The phase 1/2a trial was designed to assess the drug's safety,tolerability,pharmacokinetic profile and preliminary anti-tumor activity. MOR208wasadministered as an intravenous infusion on days 1, 4, 8, 15, and 22 ofcycle 1,and on days 1, 8, 15, and 22 of cycle 2. Dose levels tested ranged from0.3 to12 mg/kg. Among the 27 evaluable patients, three partial responses wereobservedat the 6, 9, and 12 mg/kg dose levels. In addition, 22 patientsexperiencedstable disease and only two patients progressed at the 8 week evaluationpoint.Clinical responses were assessed according to International Working Groupon CLL(IWCLL) 2008 and 1996 Guidelines. Overall response rate by IWCLL 2008criteriawas 11% which utilizes more rigorous CT scan reduction of internal lymphnodesnot previously required in older historic studies. Using IWCLL 1996responsecriteria resulted in a response rate of 42%. The most common adverse eventsweremild to moderate infusion reactions usually with the first dose.Treatment-related adverse events classified as grade 3 or higher occurredin 5 out of 27patients. Only one dose-limiting toxicity was observed in 16 patientstreated atthe 12 mg/kg dose level and the trial protocol was amended to include aperiodof extended dosing with a total of 8 patients at this dose.

"MOR208 was safe and well-tolerated in this first-in-human study, andshowspromise as an novel immunotherapy for B-cell malignancies",commented theprincipal investigator of the study John C. Byrd, MD, Professor and DWarrenBrown Chair of Leukemia Research at The James Cancer Hospital andSoloveResearch Institute. "We are really looking forward to incorporatingthistogether with other active immune and targeted therapies used for CLLin thenear future."

Final phase 1/2a data will be presented at the 2012 AmericanSociety ofHematology (ASH) annual meeting from December 8-11, 2012 in Atlanta.

"MOR208 is now well positioned to advance in development into additionalB-cellmalignancies," said Bassil Dahiyat, Ph.D., Chief Executive Officer ofXencor."The combination of tolerability and anti-tumor activity add to the growingbodyof clinical data on our XmAb(®) technology for enhancing antibodycytotoxicpotency."

In June 2010, MorphoSys AG and Xencor signed a worldwide exclusivelicense andcollaboration agreement. The agreement provided MorphoSys with anexclusiveworldwide license to MOR208 for the treatment of cancer and otherindications.Using Xencor's XmAb(®) Fc enhancement technology, MOR208 has beenengineered topossess significantly enhanced antibody-dependent cell-mediatedcytotoxicity(ADCC), thus improving a key mechanism for tumor cell killing andofferingpotential for enhanced efficacy compared to traditional antibodiesfor thetreatment of cancer. MorphoSys will be solely responsible for furtherclinicaldevelopment after successful completion of the phase 1/2a clinicaltrial.MorphoSys plans to initiate additional clinical trials for MOR208 innon-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL) byyear-end.

The full abstract is availableon

About MorphoSys:

MorphoSys developed HuCAL, the most successful antibody library technologyinthe pharmaceutical industry. By successfully applying this and otherpatentedtechnologies, MorphoSys has become a leader in the field of therapeuticantibodies, one of the fastest-growing drug classes in human healthcare.Thecompany's AbD Serotec unit uses HuCAL and other antibody technologies togenerate superior monoclonal antibodies for research and diagnosticapplications.

Together with its pharmaceutical partners, MorphoSys has built atherapeuticpipeline of more than 70 human antibody drug candidates for the treatmentofcancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few.Withits ongoing commitment to new antibody technology and drug development,MorphoSys is focused on making the healthcare products of tomorrow.MorphoSys islisted on the Frankfurt Stock Exchange under the symbol MOR. For regularupdatesabout MorphoSys, visit

About Xencor, Inc.

Xencor, Inc. engineers superior biotherapeutics using its proprietaryProteinDesign Automation(®) technology platform, and is a leader in the fieldofantibody engineering to significantly improve antibody half-life,immune-regulatory function and potency. The company is advancing multipleXmAb(®)antibody drug candidates in the clinic, including XmAb(®)5871targeting CD32band CD19 for autoimmune diseases, and an anti-CD30 candidateXmAb(®)2513 for thetreatment of Hodgkin's lymphoma. Xencor is also advancing a portfolio ofbiosuperior versions of blockbuster antibody drugs engineered for superiorhalf-life and dosing schedule. Xencor has entered into multiplepartnerships withindustry leaders such as Amgen, Pfizer, Centocor, MorphoSys, BoehringerIngelheim, CSL Ltd. and Human Genome Sciences. In these partnerships Xencorisapplying its suite of proprietary antibody Fc domains to improve antibodydrugcandidates for traits such as sustainedhalf-life and/or potency. More information is available at

HuCAL(®), HuCAL GOLD(®), HuCAL PLATINUM(®),CysDisplay(®), RapMAT(®), arYla(®)and Ylanthia(®) and 100 billion high potentials(®) areregistered trademarks ofMorphoSys AG.

Slonomics(®) is a registered trademark of Sloning BioTechnologyGmbH, asubsidiary of MorphoSys AG.

XmAb(®) is a registered trademark of Xencor, Inc.

This communication contains certain forward-looking statementsconcerning theMorphoSys group of companies. The forward-looking statements containedhereinrepresent the judgment of MorphoSys as of the date of this release andinvolverisks and uncertainties. Should actual conditions differ from theCompany'sassumptions, actual results and actions may differ from thoseanticipated.MorphoSys does not intend to update any of these forward-lookingstatements asfar as the wording of the relevant press release is concerned.

Media Release (PDF):

This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:

(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


For more information, please contact:

MorphoSys AG
Dr. Claudia Gutjahr-Loser
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

Email Contact

Xencor, Inc.
Heidi Chokeir, Ph.D.
Canale Communications for Xencor
Email Contact


Comment on this story