On January 26, 2021 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported the enrollment of the first patient in 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) (Press release, BioInvent, JAN 26, 2021, View Source [SID1234574303]). The first patient in the Phase I/IIa study has been enrolled in Denmark.
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BI-1808 is the lead development candidate from a panel of TNFR2-specific antibodies that BioInvent has generated from its proprietary n-CoDeR library and unique F.I.R.S.T discovery tool. TNFR2 is particularly upregulated on tumor-associated regulatory T cells (Tregs) and has been shown to be important for tumor expansion and survival, representing a new and important target for cancer immunotherapies.
"The start of this Phase I/IIa trial of BI-1808 is an important milestone for BioInvent’s third program in clinical development. It also further validates BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms and their ability to produce novel, differentiating drug candidates. We have generated a solid preclinical data set for BI-1808, showing exceptionally strong anti-tumor effect in several murine tumor models, and we are excited to now evaluate the potential of this unique antibody in the clinic," said Martin Welschof, CEO of BioInvent.
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 Keytruda in patients with ovarian cancer, non-small cell lung cancer and CTCL. It will also investigate the expression of immunological markers that may predict clinical responses. The trial will be conducted at several sites across Europe and the U.S. and is expected to enroll approximately 120 patients.
The Phase I stage is divided into two parts. Part A is a dose escalation study of BI-1808 to assess safety, tolerability, pharmacokinetics/pharmacodynamics, and to determine the recommended dose as a single agent for Phase II trials. Part B will explore the safety, tolerability and recommended dose of BI-1808 in combination with Keytruda. The Phase IIa stage will consist of expansion cohorts to assess signs of efficacy of BI-1808 as single agent, and in combination with Keytruda in lung cancer and ovarian cancer patients. Another cohort will explore the activity as single agent in CTCL.