Date: 22-Sep-2020

I-Mab Announces China NMPA Clearance For Phase 1 Clinical Trial Of Lemzoparlimab In Relapsed Or Refractory Advanced Lymphoma

SHANGHAI and GAITHERSBURG, Md.Sept. 21, 2020 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for lemzoparlimab (also known as TJC4) to initiate a phase 1 clinical trial in patients with relapsed or refractory advanced lymphoma (CXSL2000206) as part of an ongoing IMCT being conducted also in the U.S. Additionally, a phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in China (CXSL1900039; NCT04202003;) is currently underway with clinical results expected in early 2021. Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development.

The preliminary results of the recent phase 1 clinical trial in the U.S. have shown differentiation of lemzoparlimab in terms of safety and pharmacokinetics profiles in cancer patients. Lemzoparlimab was well tolerated as a single agent at a dose up to 30 mg/kg/week without introducing any priming dose strategy. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year. At the same time, combination therapy of lemzoparlimab with pembrolizumab in patients with solid tumors and classical Hodgkin's lymphoma are also ongoing in the U.S.

"We strongly believe that lemzoparlimab has the potential to make a significant difference in the treatment of multiple cancers, particularly hematologic malignancies in China," said Dr. Joan Shen, CEO of I-Mab. "We look forward to accelerating this program through close collaboration between the U.S. and China teams and delivering a potentially life-changing medicine to patients in need."

Earlier this month, I-Mab entered into a global strategic partnership with AbbVie to develop and commercialize lemzoparlimab. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and commercialize lemzoparlimab in mainland ChinaMacau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-related therapeutic agents