BND-22, a novel immune checkpoint inhibitor, entered Phase 1/2 trials in Q2 2021 and will be evaluated in advanced cancer patients with no alternative therapies. BND-22, was 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 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
BND-22-001 is the first-in-human clinical trial of BND-22. It is a Phase 1/2 multicenter, open label, dose escalation and expansion study enrolling advanced cancer patients with select solid tumor types. The study is evaluating the safety and tolerability, maximum tolerated dose/recommended Phase 2 dose (MTD/RP2D), pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BND-22.
The trial will be conducted at several clinical sites, initially enrolling patients in the US and Israel.