MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that the first patient in a Phase 1/2a clinical trial of its cancer antibody MOR202 has been dosed. MOR202 is a fully human HuCAL antibody directed against CD38, a therapeutic target which is highly expressed on multiple myeloma tumor cells and certain leukemias. The phase 1/2a, open-label, multi-centre, dose-escalation study will evaluate the safety and preliminary efficacy of MOR202 in patients with relapsed or refractory multiple myeloma.
'We will evaluate MOR202 both as a monotherapy and in combination with standard therapy. I am very pleased that this program has been brought forward so successfully by our development team over the past months and now represents another valuable clinical asset in our portfolio. In total, this is our third proprietary antibody program in clinical trials, following MOR103 in rheumatoid arthritis and MOR208 in chronic lymphocytic leukemia,' commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
Patients with relapsed or refractory multiple myeloma will be treated with different doses of the HuCAL-derived antibody MOR202. It is also planned to evaluate the safety of MOR202 in combination with approved therapy. Pre-clinical studies recently presented at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) demonstrated enhanced cytotoxic activity of MOR202 in combination with Velcade® and Revlimid®, supporting the clinical trial design.
In total, the clinical trial* is anticipated to enroll a maximum of 82 patients and will be conducted in several centers in Germany and Austria. The primary endpoints of the trial are to determine the safety and tolerability of multiple doses of MOR202 in patients. Secondary outcome measures will evaluate pharmacokinetics and preliminary efficacy.
More information on the trial can be found by searching for MorphoSys at http://clinicaltrials.gov.
*Supported by the German Federal Ministry of Education and Research as part of Munich's leading edge cluster m4 - Personalized medicine and targeted therapies
About MorphoSys:
MorphoSys is an independent biotechnology company that develops novel antibodies for therapeutic, diagnostic and research applications. The Company's HuCAL technology is one of the most powerful methods available for generating fully human antibodies. By successfully applying this and other proprietary technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human health-care. Through its alliances with some of the world's leading pharmaceutical companies, MorphoSys has created a pipeline of more than 60 drug candidates. The Company is expanding its drug pipeline by adding new partnered programs, and by building a portfolio of fully-owned therapeutic antibodies. For its proprietary portfolio, the Company is focused on the areas of oncology and inflammation. Its most advanced program MOR103, a first-in-class, fully human antibody against GM-CSF, is currently being tested in a Phase Ib/IIa trial in rheumatoid arthritis patients. Via its business unit AbD Serotec, MorphoSys is expanding the reach of its technologies in the diagnostics and research markets. MorphoSys is headquartered in Munich, Germany and listed on the Frankfurt Stock Exchange under the symbol 'MOR'. For further information, visit http://www.morphosys.com
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay® and RapMAT® are registered trademarks of MorphoSys; arYlaTM is a trademark of MorphoSys.