TG Therapeutics announced the commencement of a Phase I first-in-human trial of TG-1801, the company’s novel first-in-class anti-CD47/CD19 bispecific antibody, in patients with relapsed or refractory B-cell lymphoma. TG-1801 is the first therapy to target both CD19, a B-cell specific marker widely expressed across B-cell malignancies, and CD47, the “don’t eat me” signal used by both healthy and tumor cells to evade macrophage mediated phagocytosis. CD47 is expressed ubiquitously on normal cells, including red blood cells and platelets. By co-targeting both CD47 and CD19, TG-1801 has the potential to overcome the limitations of existing CD47 targeted therapies by avoiding the side effects caused by indiscriminate blockade of CD47 on healthy cells. This Phase I open label, multi-center trial is designed to assess the safety, pharmacokinetics, efficacy and recommended Phase 2 dose of TG-1801. The primary objective of the study is to determine the Maximum Tolerated Dose and characterize the safety profile of TG-1801, with secondary endpoints including characterization of pharmacokinetics and preliminary anti-cancer activity.
https://thefly.com/landingPageNews.php?id=2870157
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