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MorphoSys and I-Mab Announce FDA Clearance of IND Application for MOR210/TJ210 in Patients with Advanced Cancer

DGAP-News: MorphoSys AG / Key word(s): Miscellaneous MorphoSys and I-Mab Announce FDA Clearance of IND Application for MOR210/TJ210 in Patients with Advanced Cancer (news with additional features) 17.09.2020 / 22:03 The issuer is solely responsible for the content of this announcement. MorphoSys and I-Mab Announce FDA Clearance of IND Application for MOR210/TJ210 in Patients with Advanced Cancer

Phase 1 Clinical Study Expected to Start in Q4 2020

 

PLANEGG/MUNICH Germany and SHANGHAI, China, September 17, 2020 - MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab (Nasdaq: IMAB) today jointly announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for MorphoSys' investigational human anti-C5aR1 antibody MOR210/TJ210 for the treatment of relapsed or refractory advanced solid tumors. The phase 1 clinical trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MOR210/TJ210, may proceed and is expected to commence subsequently.

MOR210/TJ210 is a highly differentiated monoclonal antibody that is directed against complement factor C5a receptor 1 (C5aR1). Tumor and stromal cells produce C5a that attracts immunosuppressive cell types such as myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils through C5aR1 expressed on their surface, contributing to a hostile tumor microenvironment towards T cells. MOR210/TJ210 is thought to block the interaction between C5a and C5aR1 by binding to C5aR1 and retard the migration of suppressor cells. It has been shown to exert strong anti-tumor activity in combination with immune checkpoint inhibitors in preclinical studies.

"MOR210/TJ210 has demonstrated encouraging results in preclinical studies. We look forward to progressing MOR210/TJ210 into clinical studies which will enable us to characterize the safety and tolerability of MOR210/TJ210, as well as its potential clinical benefits in patients with cancers", said Dr Joan Shen, Chief Executive Officer of I-Mab.

"The FDA clearance of the IND application to initiate a Phase 1 clinical trial of MOR210/TJ210 is an important step forward in developing a new treatment for patients with advanced cancer", said Dr Malte Peters, Chief Research & Development Officer of MorphoSys. "We look forward to joining forces with I-Mab in developing highly innovative treatments in oncology and are pleased to support our partner during this significant phase."