Benzinga | Sep 30, 2021 08:03AM EDT

I-Mab Provides Clinical Updates Of Differentiated CD47 Antibody Lemzoparlimab

* The preliminary efficacy and safety data from the phase 2 U.S. trial in NHL has been submitted for presentation at ASH 2021 The current U.S. NHL clinical trial has now expanded to include clinical sites in China as an international multi-center clinical trial, which will potentially lead to a registrational trial in China upon approval by the NMPA

* The on-going clinical trial of lemzoparlimab in combination with AZA for AML/MDS is on track for completion of patient enrollment by Q4 2021, which will potentially lead to a registrational trial in China upon approval by the NMPA

* NMPA has recently approved the IND application for a phase 2 clinical trial of lemzoparlimab in combination with toripalimab in patients with advanced solid tumors

SHANGHAI and GAITHERSBURG, Md., Sept. 30, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced multiple clinical advancements of its anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4).



I-Mab has initiated a phase 2expansion trial (NCT03934814) of lemzoparlimab in combination with rituximab (Rituxan(r)) in non-Hodgkin's lymphoma (NHL) patients in China. The expanded trial is part of the ongoing international multi-center trial (IMCT) that is being conducted in the U.S. and now also in China. The study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamic (PD) and determine the recommended phase 2 dose (RP2D) of lemzoparlimab in combination with rituximab in patients with lymphomas. On September 28, 2021, the first patient in the expanded trial was dosed. Patient enrollment for the trial is expected to be completed in a few months.

Progress in clinical trials of lemzoparlimab in NHL and AML/MDS:

* In the U.S. clinical trial of lemzoparlimab in combination with rituximab for NHL patients, the preliminary efficacy and safety data have been summarized and submitted for presentation at the 2021 American Society of Hematology (ASH) Annual Meeting. The expanded clinical trial is on track and expected, pending approval by the NMPA, to lead to a registrational trial in patients with NHL in 2022 in China.

* In the China clinical trial of lemzoparlimab in combination with azacitidine (AZA) in patients with myelodysplastic syndrome (MDS), preliminary clinical response data is being evaluated, and patient enrollment is on track for completion in Q4 2021, the complete data set will be analyzed and reported at a later time. The Company plans to initiate another registrational trial in patients with MDS in 2022 in China based on the efficacy and safety data from this study, pending approval by the NMPA.

Progress in clinical trials of lemzoparlimab in patients with solid tumors:

I-Mab is currently investigating lemzoparlimab in combination with pembrolizumab (Keytruda(r)) in advanced solid tumors in U.S. Data readout is expected in early 2022. Further, on September 16, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) approved the Company's IND application to advance to a phase 2 clinical trial of lemzoparlimab in combination with toripalimab (TUOYI(r)) in patients with advanced solid tumors. The combined clinical results will potentially support a registrational trial later in China.

In all clinical trials conducted so far by the Company, including NHL, AML/MDS and solid tumors, lemzoparlimab have been evaluated without the need of a priming dose.

"Accumulative data from the ongoing lemzoparlimab clinical trials further increase our understanding of its safety, PK and efficacy profile," said Dr. Joan Shen, CEO of I-Mab. "We are encouraged by the clinical data of lemzoparlimab obtained so far and are rapidly advancing the clinical development of lemzoparlimab towards multiple registrational trials, with the goal of becoming the first CD47 antibody drug in China."