On November 9, 2020 BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported that new data on BI-1808, a monoclonal antibody to tumor necrosis factor receptor 2 (TNFR2) which is expected to enter Phase I/IIa clinical development before the end of 2020 (Press release, BioInvent, NOV 9, 2020, View Source [SID1234570661]).

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The poster presentation at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), entitled "Pre-clinical development of TNFR2 ligand-blocking BI-1808 for cancer immunotherapy" (Abstract number: 725), describes the results from a preclinical toxicology study of BI-1808 in cynomolgus macaques. Three doses of BI-1808 (2, 20 and 200 mg/kg) were administered weekly for four consecutive weeks followed by a recovery period of eight weeks. In addition, results from T-cell stimulation assays and a humanized mouse model evaluating cytokine release were also presented. The data showed that BI-1808 had an expected pharmacokinetic (PK) profile and was well tolerated in doses up to 200 mg/kg. Using a BI-1808 mouse surrogate antibody in a tumor model, a close correlation between dose, exposure, receptor occupancy and anti-tumor response was demonstrated. These data have been used to calculate the starting dose for the upcoming First-in-human (FIH) trial.

The poster will be available in the Virtual Poster Hall November 11-14, 2020, 9:00 a.m. – 5:00 p.m. EST (3:00 – 11:00 p.m. CET). The presenting authors will answer questions on Wednesday, November 11 from 5:15 to 5:45 p.m. EST (11:15 – 11: 45 p.m. CET) and Friday, November 13 from 4:40 to 5:10 p.m. EST (10:40 – 11: 10 p.m. CET).

TNFR2 is particularly upregulated on tumor-associated regulatory T cells (Tregs) and has been shown to be important for their expansion and survival. As a part of its Treg program, BioInvent identified and characterized a wide panel of TNFR2-specific antibodies, generated from its proprietary n-CoDeR library and unique F.I.R.S.TTM discovery tool, of which BI-1808 is the lead development candidate.

"BI-1808 is a very promising drug candidate which further validates the productivity of BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms. BI-1808 has demonstrated exceptionally strong anti-tumor effects in a several of murine tumor models. It depletes intra-tumoral Tregs, induces and expands intra-tumoral CD8+ T-cells in vivo and synergizes with anti-PD1 treatment. Based on these strong preclinical data, we are looking forward to testing the ability of BI-1808 to treat cancer patients," said Martin Welschof, CEO of BioInvent

BI-1808 is expected to enter clinical development before the end of 2020, further expanding BioInvent’s clinical pipeline of novel drug candidates. BioInvent is assessing BI-1206 in Phase I/IIa studies for the treatment of hematological cancers and solid tumors. In partnership with Transgene, BioInvent is also about to enter clinical development with BT-001, a next generation oncolytic virus expressing a proprietary anti-CTLA4 antibody.