On January 18, 2022 I-Mab reported that the first patient has been dosed in its China Phase II trial of lemzoparlimab in combination with the PD-1 antibody toripalimab (TUOYI) in patients with advanced solid tumors (Press release, I-Mab Biopharma, JAN 18, 2022, View Source [SID1234605605]). The phase 2 study is designed as a basket trial and could potentially lead to a registrational trial in China.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are pleased to initiate the phase 2 trial for the combination of lemzoparlimab and toripalimab in patients with advanced solid tumors in China, and looking forward to accelerating its clinical development," said Dr. Andrew Zhu, President at I-Mab. "We are leveraging our translational medicine findings to select tumors with a higher probability of success for this trial."
Lemzoparlimab is a novel CD47 antibody that exerts strong anti-tumor activity while exhibiting minimal binding to red blood cells based on pre-clinical data. It is being evaluated in combination with pembrolizumab (Keytruda) in advanced solid tumors in the U.S. and in patients with NHL and AML/MDS in other ongoing clinical studies in the U.S. and China. In all clinical trials conducted so far, lemzoparlimab has been administered without a priming dose.
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 has been 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 discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.
Multiple clinical studies are ongoing in both the U.S. and China to explore indications in treating both hematologic malignancies and solid tumors. Lemzoparlimab is being studied in patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors in the U.S. and China. Combined clinical results from these studies could potentially support future registrational trials in China.
In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab. This includes the design and conduct of further clinical trials to evaluate lemzoparlimab in multiple cancers in China and globally. AbbVie has assumed sponsorship of the U.S. study as of April 2021.