Lund, Sweden /PRNewswire/ - BioInvent International AB (BINV) today announces it has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with an Investigational New Drug (IND) application for a Phase I/IIa clinical trial of an immune-modulatory anti-FcγRllB antibody in combination with an anti-PD1 antibody in solid tumors.
The anti-FcγRllB antibody is part of BioInvent's FcγRIIB-targeting program, which has emerged from its F.I.R.S.T™ platform technology, which simultaneously identifies both targets and high-quality antibodies that bind to them, generating potentially promising new drug candidates. The Phase I/IIa trial is planned to be carried out in the U.S. and the EU.
"This antibody may improve the therapeutic efficacy of anti-PD1 targeting antibodies, and this study will explore the potential to improve responses observed in the treatment of solid cancers. Progressing this first in class monoclonal antibody into clinical development further reinforces the productivity of BioInvent's platform, which continues to produce novel cancer therapies which not only broaden our own pipeline, but also add further licensing and partnering opportunities," says BioInvent's CEO Martin Welschof.
The Phase I/IIa study is one of four new clinical programs in solid cancers that the Company intends to initiate. These also include BI-1607 (an anti-FcγRllB antibody) in combination with a checkpoint inhibitor; BI-1808 (an anti-TNFR2 antibody); and the collaboration with Transgene to develop oncolytic viruses encoding a validated anti-CTLA-4 antibody.
BioInvent International AB (OMXS: BINV) is focused on the discovery and development of novel and first-in-class immuno-modulatory antibodies to treat cancer. The Company's lead program BI-1206, is currently in Phase l/ll for non-Hodgkin lymphoma and chronic lymphatic leukemia. BioInvent's pre-clinical portfolio is focused on targeting key immune suppressive cells and pathways of the tumor microenvironment, including regulatory T cells, tumor-associated myeloid cells and mechanisms of antibody drug-resistance. The Company has a strategic research collaboration with Pfizer Inc., and partnerships with Transgene, Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma. BioInvent generates near term revenues from its fully integrated manufacturing unit producing antibodies for third parties for research through to late-stage clinical trials. More information is available at www.bioinvent.com.
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