BND-22, is Biond’s most advanced asset, BND-22 was recently partnered with Sanofi for $125 million upfront payment, and up to $1 billion in development, regulatory, and sales milestones and double-digit royalties. BND-22, a novel immune checkpoint inhibitor, just entered clinical trials and will be evaluated in advanced cancer patients with no alternative therapies
BND-22 Clinical plan
Biond is leading the first-in-human, phase 1a study of BND-22, evaluating its safety and tolerability as a single agent and in combination with approved cancer therapeutics as well as exploring potential associations between BND-22 anti-tumor activity and select tumor and blood-based biomarkers.
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.