October 26, 2020 -- BioInvent International has received approval for its clinical trial application (CTA) in Denmark for a phase I/IIA first-in-human study of BI-1808 for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL).
BI-1808 is an antitumor necrosis factor receptor 2 antibody developed using the company's n-Coder and First platforms to generate antibodies to novel targets with potent antitumor activity. The company expects to enroll the first patient in a clinical trial by the end of 2020 and submit an investigational new drug application in the coming weeks.
The study will investigate the safety, tolerability, and potential signs of efficacy of BI-1808 as a monotherapy and in combination with Keytruda in patients with ovarian cancer, non-small cell lung cancer, and CTCL. In total, 120 patients are expected to be enrolled in sites across Europe and the U.S.
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