Biond Biologics and Sanofi have entered into a worldwide licensing agreement to advance BND-22, a novel immune checkpoint inhibitor, into clinical testing as a potential treatment of solid tumors. An investigational new drug (IND) application, requesting that the treatment be cleared for patient trials, was recently filed with the U.S. Food and Drug Administration. If approved, a first clinical trial in advanced cancer patients is planned to begin by mid-year, the companies announced. "We are thrilled to partner with Sanofi, an organization with a global footprint and exceptional drug development and commercialization capabilities," Ori Shilo, co-founder and chief financial officer at Biond, said in a press release. Biond's lead antibody, BND-22, is a multi-cell checkpoint inhibitor that targets the Ig-like transcript 2 (ILT2) receptor, an inhibitory receptor used by cancer cells to dampen immune responses. This immunosuppressive mechanism is mediated by the binding of the receptor to HLA-G, a protein produced by several types of cancer cells. In preclinical studies, BND-22 showed a wide anti-tumor immune response by blocking ILT2-mediated "do not eat me" signals in immune cells called macrophages, and by enhancing the activity of other immune cells, namely natural killer (NK) and cytotoxic T-cells. "BND-22, the first clinical drug candidate to graduate Biond's development model, is a novel immunotherapy that targets both adaptive and innate immune cells and takes advantage of the anti-tumor activity of not only T cells but also that of additional immune cells, such as NK cells and macrophages,” said Tehila Ben-Moshe, PhD, co-founder and CEO of Biond. The planned first-in-human Phase 1a clinical trial will investigate BND-22 in people with advanced solid tumors. It is to be conducted at multiple clinical sites across the U.S. and Israel. The study will evaluate the safety, tolerability, pharmacokinetics (the movement of a drug into, through, and out of the body), and preliminary signs of efficacy of BND-22, both alone and in combination with approved cancer therapies. The study will also explore the potential associations between BND-22’s anti-tumor activity and select tumor and blood-based biomarkers. Under the terms of the partnership agreement, Biond will be leading the Phase 1a trial. Sanofi will be responsible for future clinical development and commercialization of BND-22. Biond will also receive an initial payment of $125 million in cash, and is eligible for additional payments of more than $1 billion for development, regulatory and commercial milestones, as well as tiered royalties. “We look forward to progressing BND-22 into the clinic together with our new partner Sanofi, using our in-depth knowledge of the ILT2 pathway and expertise in immuno-oncology," Ben-Moshe said.