On October 15, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the Company’s abstract highlighting its U.S. phase 1 dose escalation trial data from its CD47 program, lemzoparlimab (also known as TJC4) in relapsed or refractory malignancy, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 – 14, 2020 (Press release, I-Mab Biopharma, OCT 15, 2020, View Source [SID1234568537]). The data to be presented will include clinical safety, pharmacokinetics (PK) & pharmacodynamics (PD), receptor occupancy (RO), and preliminary evidence of efficacy of lemzoparlimab as a monotherapy.
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Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab that has been designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in differentiating lemzoparlimab from other antibodies of the same class currently in clinical development. Initial results from I-Mab’s phase 1 study in U.S. described above have demonstrated the unique differentiation in drug safety and pharmacokinetics profile in cancer patients.
Details of the poster are as follows:
Title
A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody,
in subjects with relapsed/refractory malignancy: initial monotherapy results
Abstract #
385
Presenting Author
Jordan Berlin, MD, Vanderbilt University
The abstract is available at View Source
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, making it a potentially promising cancer drug. 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. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.
Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumor and with Rituxan for lymphoma in the U.S., in addition to an on-going clinical trial in patients with AML/MDS in China.
In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.