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

I-Mab, and MorphoSys 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 TJ210/MOR210 monotherapy in patients with relapsed or refractory advanced solid tumors in the United States.

TJ210/ MOR210 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. TJ210/MOR210 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. TJ210/MOR210 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 TJ210/MOR210 in subjects with advanced solid tumors. The development program will evolve into further clinical combination studies of TJ210/MOR210 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."

"We look forward to progressing with TJ210/MOR210 into clinical studies together with I-Mab to investigate its potential as a novel therapeutic option for patients with advanced solid tumors," said Dr. Malte Peters, Chief Research & Development Officer of MorphoSys.

MorphoSys will receive a $1.5 million payment from I-Mab for achieving this milestone under the license agreement between the two companies. MorphoSys and I-Mab entered into an exclusive strategic collaboration and licensing agreement to develop and commercialize TJ210/MOR210 in November 2018. Under the terms of agreement, I-Mab receives exclusive rights to develop and commercialize TJ210/ MOR210 in Greater China and South Korea, while MorphoSys retains rights in other parts of the world. With support from MorphoSys, I-Mab will also fund and conduct all global development activities of TJ210/MOR210, including clinical trials in China and the U.S., towards clinical proof-of-concept (PoC) in oncology.

About TJ210/MOR210

TJ210/MOR210 is a novel human antibody directed against C5aR1 derived from MorphoSys's HuCAL Platinum® technology. C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function of C5a and enabling immune cells to attack the tumor.

HuCAL Platinum® is a registered trademark of MorphoSys AG.

About I-Mab

I-Mab (Nasdaq: IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies. The Company is progressing from a clinical stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou and Hong Kong, S.A.R., China in China, and Maryland and San Diego in the United States.

About MorphoSys

MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees.