On September 30, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported multiple clinical advancements of its anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4) (Press release, I-Mab Biopharma, SEP 30, 2021, View Source [SID1234590606]).
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I-Mab has initiated a phase 2 expansion trial (NCT03934814) of lemzoparlimab in combination with rituximab (Rituxan) 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) (Free ASH Whitepaper) 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) 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) 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."
About CD47 and Lemzoparlimab
CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.
I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumors in the U.S. and with Rituxan for lymphoma in the U.S. and China, in addition to an on-going clinical trial in patients with AML in China.
In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. AbbVie has assumed sponsorship of the U.S. study as of April 2021.