LUND, Sweden, Nov. 9, 2020 /PRNewswire/ -- 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, today presents 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.
The poster presentation at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), 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.
BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Two preclinical programs in solid tumors are expected to have entered clinical trials by the end of 2020. The Company's validated, proprietary F.I.R.S.T technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company's own clinical development pipeline or for additional licensing and partnering.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com.
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