CTA approval of BioInvent's BI-1808, a first-in-class anti-TNFR2 antibody, sets stage for Phase I/IIa trial

BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces it has received regulatory authority approval of its clinical trial application (CTA) in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda® (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). Martin Welschof, CEO of BioInvent, says, "CTA approval for our Phase I/IIa trial of BI-1808 marks the first anti-TNFR2 antibody to enter clinical development. BI-1808 is a first-in-class anti-TNFR2 antibody, which we believe is a very promising approach for cancer therapy, and testament to the power of our proprietary n-CoDeR® and F.I.R.S.TTM platforms to generate antibodies to novel targets with potent anti-tumoral activity. We expect to enroll the first patient before the end of the year and to submit an investigational new drug (IND) application in the U.S. in the coming weeks." The study will explore the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with Keytruda® in patients with ovarian cancer, non-small cell lung cancer and CTCL. It will also investigate the expression of potential immunological markers that might be associated with clinical responses. The trial will be conducted at several sites across Europe and the U.S. and is expected to enroll approximately 120 patients.