BND-22 is Biond’s leading asset – it is a first-in-class, multi-cell checkpoint inhibitor targeting the Ig-like transcript 2 (ILT2) receptor, in development for the treatment of solid tumors.
ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds HLA-G, an immunosuppressive molecule expressed by multiple tumor types.
BND-22 Mode of Action
BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated “do not eat me” signals in macrophages and by activating NK and CD8+ lymphocytes. The program is supported by a comprehensive biomarker strategy designed to guide patient enrollment in advanced clinical trials and is on track for an FDA IND submission in Q4 2020.
BND-22 enhances the ability of macrophages to phagocytose tumor cells
BND-22 enhances anti-tumor activity of T cells and NK cells
Illustration of the MOA of BND-22: The tumor microenvironment contains macrophages and NK cells that are inhibited through HLA-G-ILT2 interactions (1). Once BND-22 is added, the antibody increases the innate immune response by enhancing both phagocytosis by macrophages and cytotoxicity of NK cells leading to tumor cell destruction and release of tumor antigens (2). These tumor antigens are released and are presented by antigen presenting cells in the periphery (3) which leads to T cell priming, activation and eventually infiltration into the tumor (4). In parallel, BND-22 acts directly on T cells to increase their activation and cytotoxicity in the tumor microenvironment (5). Taken together, this demonstrates the ability of BND-22 to generate a broad anti-tumor response which is mediated by its ability to activate innate and adaptive immune cells.
BND-22 Clinical Development
We are currently conducting IND-enabling studies and expect to file an IND for BND-22 in the fourth quarter of 2020. We plan to initiate, in the first quarter of 2021, a first-in-human, multicenter, open-label, phase 1/2 clinical trial in advanced cancer patients with solid tumors known to express HLA-G. The study will evaluate the safety and tolerability, pharmacokinetics, and antitumor activity of BND-22 as a single agent regimen. The trial is planned to be conducted at multiple clinical sites, initially enrolling patients in the US and Israel. BND-22’ clinical development program is supported by a comprehensive biomarker strategy designed to allow patient enrollment in advanced clinical trials based on specific patient and tumor characteristics.