DGAP-News: MorphoSys AG / Key word(s): Miscellaneous Media Release MorphoSys Receives FDA Breakthrough Therapy Designation for Its Antibody MOR208 in Relapsed/Refractory DLBCL Designation is intended to expedite development of MorphoSys's most advanced blood cancer drug candidate MOR208 in combination with cancer drug lenalidomide MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to MOR208, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not eligible for high-dose chemotherapy and autologous stem-cell transplantation. MOR208 is an investigational Fc-engineered monoclonal antibody directed against CD19 which is currently in clinical development in blood cancer indications. FDA Breakthrough Therapy designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs. It is granted if preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies in the treatment of a serious or life-threatening disease. DLBCL is the most frequent type of malignant lymphoma worldwide and accounts for approximately 30% of all non-Hodgkin lymphomas. Between 30% and 40% of all patients with DLBCL either fail to respond to or show a relapse to initial therapy. "DLBCL is a very aggressive lymphoma. In particular, those patients who fail standard treatments are in need of more therapeutic options. We look forward to working closely with the FDA and to develop MOR208 as a potential new treatment option for these patients as quickly as possible," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG. FDA's Breakthrough Therapy designation is based on preliminary data from the ongoing phase 2 L-MIND study (NCT02399085), which is evaluating the safety and efficacy of MOR208 in combination with lenalidomide in patients with R/R DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplantation. Preliminary data based on 34 eligible patients presented at ASCO 2017, showed an objective response rate (ORR) of 56% and a complete response rate of 32%. "For MorphoSys, relapsed/refractory DLBCL is a key development focus. We expect to report further data from our ongoing phase 2 L-MIND trial with MOR208 plus lenalidomide at this year's American Society of Hematology conference in December. In addition, we are currently evaluating MOR208 in combination with bendamustine in our phase 3 B-MIND trial. MorphoSys intends to speed up and potentially broaden the development of MOR208 in other indications of unmet need," Dr. Peters continued. About CD19 and MOR208 About MorphoSys 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 Jochen Orlowski Alexandra Goller Tel: +49 (0) 89 / 899 27-404 Additional features: Document: http://n.eqs.com/c/fncls.ssp?u=HGVBYSCVCU Document title: Media Release 23.10.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
Language: | English |
Company: | MorphoSys AG |
Semmelweisstr. 7 | |
82152 Planegg | |
Germany | |
Phone: | +49 (0)89 899 27-0 |
Fax: | +49 (0)89 899 27-222 |
E-mail: | investors@morphosys.com |
Internet: | www.morphosys.com |
ISIN: | DE0006632003 |
WKN: | 663200 |
Indices: | TecDAX |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange |
End of News | DGAP News Service |