{"id":23726,"date":"2023-09-20T09:26:20","date_gmt":"2023-09-20T07:26:20","guid":{"rendered":"https:\/\/www.izb-online.de\/morphosys-wirkstoff-tulmimetostat-erhaelt-fast-track-status-der-fda-innovations-und-gruenderzentrum-biotechnologie-izb\/"},"modified":"2023-09-20T09:30:29","modified_gmt":"2023-09-20T07:30:29","slug":"morphosys-program-tulmimetostat-receives-fda-fast-track-designation-innovations-und-gruenderzentrum-biotechnologie-izb","status":"publish","type":"post","link":"https:\/\/www.izb-online.de\/en\/izb-biotech-news\/morphosys-program-tulmimetostat-receives-fda-fast-track-designation-innovations-und-gruenderzentrum-biotechnologie-izb\/","title":{"rendered":"MorphoSys\u2019 program tulmimetostat receives FDA Fast Track designation"},"content":{"rendered":"

[vc_row el_class=”gco-magazine-container”][vc_column el_class=”bildspalte”][vc_row_inner][vc_column_inner offset=”vc_col-lg-12 vc_col-md-12″][vc_column_text el_class=”gco-magazine–title”]<\/p>\n

MorphoSys\u2019 program tulmimetostat receives FDA Fast Track designation<\/h1>\n

[\/vc_column_text][vc_column_text el_class=”gco-magazine-lead”]Tulmimetostat is being developed for the treatment of patients with endometrial cancer and is the company’s third clinical program to achieve this status.[\/vc_column_text][vc_column_text el_class=”gco-magazine–post-date”]September, 2023[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner][vc_single_image image=”23724″ img_size=”full”][vc_column_text el_class=”gco-magazine-copyright”]\u00a9 MorphoSys[\/vc_column_text][vc_column_text el_class=”gco-magazine-picture-discription”]Laboratory MorphoSys[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine–quote” css=”.vc_custom_1611310713611{margin-top: 33px !important;}”][vc_column_inner][vc_column_text]<\/p>\n

\u201cReceiving Fast Track designation from the FDA for tulmimetostat in ARID1A-mutated endometrial cancer underscores this investigational therapy\u2019s potential in a patient population with limited treatment options. The preliminary results from our Phase 1\/2 study of tulmimetostat are very promising.\u201d<\/h6>\n

Tim Demuth, M.D., Ph.D., MorphoSys Chief Research and Development Officer<\/p>\n

[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine-container–copy” css=”.vc_custom_1591795890737{margin-top: 21px !important;}”][vc_column_inner][vc_column_text]IZB-alumnus MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced in mid-September that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tulmimetostat, the company\u2019s investigational next-generation dual inhibitor of EZH2 and EZH1, for the treatment of patients with advanced, recurrent or metastatic endometrial cancer harboring AT-rich interacting domain containing protein 1A (ARID1A) mutations and who have progressed on at least one prior line of treatment. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines intended to treat serious conditions and potentially address an unmet medical need, with the goal of getting these important, new therapies to patients earlier.<\/p>\n

Tulmimetostat was designed to improve on first generation EZH2 inhibitors through increased potency, longer residence time on target and a longer half-life, offering the potential for enhanced anti-tumor activity. The Fast Track designation in endometrial cancer was granted based on preclinical results and preliminary clinical data from an ongoing Phase 1\/2 study. This study is investigating tulmimetostat as a monotherapy in patients with advanced solid tumors or lymphomas, including ARID1A-mutated endometrial carcinoma and ovarian clear cell carcinoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma and castration-resistant prostate cancer. Updated results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June.<\/p>\n

\u201cReceiving Fast Track designation from the FDA for tulmimetostat in ARID1A-mutated endometrial cancer underscores this investigational therapy\u2019s potential in a patient population with limited treatment options,\u201d said Tim Demuth, M.D., Ph.D., MorphoSys Chief Research and<\/p>\n

Development Officer. \u201cThe preliminary results from our Phase 1\/2 study of tulmimetostat are very promising. We will continue to generate data from this study across tumor types to inform our future development plans for tulmimetostat, both as a monotherapy and in combination with other treatments.\u201d<\/p>\n

Tulmimetostat is MorphoSys\u2019 third clinical program to receive Fast Track designation from the FDA. Pelabresib, an investigational BET inhibitor, received Fast Track designation for myelofibrosis in 2018, and tafasitamab, a CD19-targeting immunotherapy, received this designation for relapsed or refractory diffuse large B-cell lymphoma in 2014.<\/p>\n

MorphoSys develops innovative cancer medicines
\n<\/strong>At MorphoSys, we are driven by our mission: More life for people with cancer. As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at www.morphosys.com<\/a><\/p>\n

About Tulmimetostat
\n<\/strong>Tulmimetostat (CPI-0209) is an investigational compound designed to exert anti-tumor activity by inhibiting the function of enhancer of zeste homolog 1 and 2 (EZH2 and EZH1) proteins to reactivate silenced genes like tumor suppressor genes. Tulmimetostat is being tested as a once-daily oral treatment in a Phase 1\/2 trial (NCT04104776) in patients with advanced solid tumors or lymphomas, including ARID1A-mutated ovarian clear cell carcinoma and endometrial carcinoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma and castration-resistant prostate cancer. The primary objectives of the trial include determining the maximum tolerated dose and\/or recommended Phase 2 dose and evaluating antitumor activity of tulmimetostat monotherapy. The safety and efficacy of tulmimetostat have not been established.[\/vc_column_text][vc_column_text css=”.vc_custom_1583761043671{background-color: #1e73be !important;}” el_class=”redaktionell”][\/vc_column_text][\/vc_column_inner][\/vc_row_inner]\n\n

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\n MorphoSys AG <\/div>\n\n