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.
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