Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

MorphoSys and Xencor Report Clinical Data for MOR208/XmAb5574

Published: Thursday, January 31, 2013
Last Updated: Wednesday, January 30, 2013
Bookmark and Share
Phase 1/2a trial in CLL/SLL patients met primary and secondary objectives.

MorphoSys AG and US-based Xencor, Inc. have 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.

Schottelius continued, "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 was 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.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

MorphoSys AG Reports Results for the First Six Months of 2015
Therapeutic pipeline exceeds 100 drug candidates in research & development.
Saturday, August 08, 2015
MorphoSys Announces Clinical Milestone in Blood Disorders Program
Company has received milestone payment from Novartis.
Saturday, July 25, 2015
MorphoSys Presents Updated Phase 2 Clinical Results for MOR208
Matured data set shows six complete remissions with durable responses in diffuse large B-cell lymphoma and follicular lymphoma.
Thursday, June 04, 2015
MorphoSys Presents First Safety, Pharmacokinetic and Efficacy Data for MOR202
Clinical activity and long-lasting tumor control already observed at low doses.
Wednesday, June 03, 2015
MorphoSys to Present Data on Proprietary Programs at 20th Congress of EHA
Substantial data packages on lead compounds MOR202 and MOR208.
Tuesday, May 26, 2015
MorphoSys to Present Data on Proprietary Programs at ASCO Annual Meeting
Abstracts include first clinical data for MOR202.
Tuesday, May 26, 2015
MorphoSys AG Reports Results for the First Three Months of 2015
First quarter positively impacted by one-off effects relating to MOR202.
Tuesday, May 12, 2015
MorphoSys to Receive Milestone Payment for Guselkumab Program
Company initiates phase 2 clinical trial in psoriatic arthritis with the HuCAL antibody.
Tuesday, April 14, 2015
MorphoSys and Celgene Mutually Agree to End MOR202 Collaboration
MorphoSys regains rights to MOR202 antibody against CD38 and updates its financial guidance for 2015.
Friday, March 27, 2015
MorphoSys and Emergent BioSolutions Initiate Phase 1 Clinical Study
Phase 1 study to evaluate the novel oncology immunotherapeutic MOR209/ES414 for prostate cancer.
Wednesday, March 11, 2015
MorphoSys Provides Update on the Company's Proprietary Drug Portfolio
Early-stage portfolio now fully Ylanthia-based, includes programs with Merck Serono as well as first anti-GPCR programs.
Tuesday, July 29, 2014
MorphoSys Announces Additional Clinical Trial of MOR208
Phase 2 study in CLL will evaluate MOR208 in combination with lenalidomide.
Wednesday, December 11, 2013
MorphoSys Strengthens European Patent Position on Anti-CD19 Cancer Program MOR208
New patent has a scheduled expiry date in 2027.
Tuesday, December 03, 2013
MorphoSys Strengthens Patent Position on anti-CD19 Cancer Program MOR208
New patent covers the antibody's protein sequence.
Tuesday, October 22, 2013
MorphoSys and Xencor Provide Update on Phase 1/2a Trial in CLL/SLL for MOR208
Extended treatment resulted in higher overall response rate.
Tuesday, October 08, 2013
Scientific News
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Computerized Flexible Needles Prove Themselves in Biological Tissue
The advantage of the system is that you can avoid obstacles with the needles or critical tissues and that the system during the insertion of the needle in real time can adjust the path if, for example, the tissue deforms.
DARWIN 2 24-week Monotherapy Data in RA Confirm Previous Results
Safety profile in DARWIN 2 consistent with previous filgotinib RA studies.
Researchers Publish Landmark “Basket Study”
Researchers from Memorial Sloan Kettering Cancer Center (MSK) have announced results from the first published basket study, a new form of clinical trial design that explores responses to drugs based on the specific mutations in patients’ tumors rather than where their cancer originated.
Agricultural Intervention Improves HIV Outcomes
A multifaceted farming intervention can reduce food insecurity while improving HIV outcomes in patients in Kenya, according to a randomized, controlled trial led by researchers at UC San Francisco.
Overdose of Vitamin D in Teenagers May Lead to Increased Cholesterol Levels
Dosing obese teens with vitamin D shows no benefits for their heart health or diabetes risk, and could have the unintended consequences of increasing cholesterol and fat-storing triglycerides. These are the latest findings in a series of Mayo Clinic studies in childhood obesity.
Phase 2 Trials Underway for New Single Dose Malaria Treatment
The new drug, which prevents the malaria parasite from reproducing and spreading, is now undergoing Phase II clinical trials in humans.
Promising Drug for Parkinson's Disease
A drug which has already been in use for decades to treat liver disease could be an effective treatment to slow down progression of Parkinson’s disease, scientists from the University of Sheffield have discovered.
Benefits of Early Antiretroviral Therapy in HIV Infection
Scientists have explored the clinical importance of starting treatment early in individuals suffering with HIV.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!