The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) for the Phase I/IIa clinical study of the immuno-modulatory anti-TNFR2 antibody BI-1808.
“FDA approval of the Phase I/IIa study of BI-1808 is another important milestone for BioInvent as we continue to broaden our exciting pipeline of anti-cancer antibodies. TNFR2 is increasingly attracting interest as revealed by the recent deals in the field. The development of BI-1808 is supported by an impressive set of preclinical data and is one of three BioInvent lead candidates in clinical development,” says Martin Welschof, CEO of BioInvent in a press release.
The Phase I/IIa study
The Phase I/IIa study will evaluate the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent, and in combination with the anti-PD-1 therapy Keytruda in patients with ovarian cancer, non-small cell lung cancer and CTCL. It is planned to be carried out in the U.S., Denmark, Hungary, the United Kingdom and Russia and is already enrolling patients.
Photo of Martin Welschof: BioInvent