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MorphoSys AG: MorphoSys and I-Mab Announce First Patient Dosed in U.S. Phase 1 Study of MOR210/TJ210 in Patients with Advanced Cancer

DGAP-News: MorphoSys AG / Key word(s): Miscellaneous MorphoSys AG: MorphoSys and I-Mab Announce First Patient Dosed in U.S. Phase 1 Study of MOR210/TJ210 in Patients with Advanced Cancer 25.01.2021 / 22:00 The issuer is solely responsible for the content of this announcement. Media Release MorphoSys and I-Mab Announce First Patient Dosed in U.S. Phase 1 Study of MOR210/TJ210 in Patients with Advanced Cancer

PLANEGG/MUNICH, Germany and SHANGHAI, China - January 25, 2021 - MorphoSys (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab (NASDAQ: IMAB) today announced that the first patient has been dosed in a phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MOR210/ TJ210 monotherapy in patients with relapsed or refractory advanced solid tumors in the United States.

MOR210/TJ210 is a monoclonal antibody developed by MorphoSys that is directed against complement factor C5a receptor 1 (C5aR1). Produced in the tumoral microenvironment, its ligand C5a acts as a chemoattractant to recruit tumor-promoting cells such as myeloid-derived suppressor cells, M2 macrophages and neutrophils. MOR210/TJ210 is designed to induce anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells.

Preclinical studies have shown that targeting the C5aR-C5a axis exerts anti-tumor activity with immune checkpoint inhibitors. Furthermore, in vitro activity was observed for blocking the C5a/C5aR pathway also at very high C5a concentrations leading to a long duration of action. MOR210/TJ210 demonstrated a good safety profile with no observed adverse effects up to the highest dose tested in non-clinical safety studies.

The phase 1 clinical trial is an open-label dose escalation study with multiple doses in multiple centers in the U.S. to evaluate the safety, tolerability, and PK/PD of MOR210/TJ210 in subjects with advanced solid tumors. The development program will evolve into further clinical combination studies of MOR210/TJ210 with checkpoint inhibitors.

"We are encouraged by the data observed in the preclinical studies and believe that TJ210/MOR210 with its unique properties has great potential to target difficult-to-treat cancers," said Dr. Joan Shen, CEO of I-Mab. "The data generated from this study will provide valuable information about TJ210/MOR210's safety and tolerability profile and its potential benefits in patients with advanced cancers."