NEW YORK – Israeli cancer immunotherapeutics developer Biond Biologics said on Tuesday that it will receive $125 million upfront from Sanofi under an exclusive global licensing agreement to develop and commercialize its ILT2-targeting antagonist antibody BND-22 in solid tumors.
In addition to the upfront payment, Biond may also receive more than $1 billion in development, regulatory, and sales milestone payments from Sanofi, as well as tiered double-digit royalty payments.
Under the terms of the deal, Biond will be in charge of exploring the safety and tolerability of BND-22 as a monotherapy and in combination with other cancer drugs in a Phase Ia study. The company recently submitted an investigational new drug application with the US Food and Drug Administration to launch a Phase I study for BND-22, which is expected to begin in mid-2021.
In this trial, Biond's researchers will also investigate BND-22's antitumor activity in specific tumor and blood biomarkers. Sanofi will lead development and commercialization efforts once BND-22 progresses beyond this initial phase.
"We believe this collaboration creates substantial value for our shareholders and validates Biond's long-term strategy to establish valuable partnerships with leading biopharmaceutical companies," Biond CFO and Co-founder Ori Shilo said in a statement.
In preclinical trials, BND-22 has shown the ability shut down ILT2-mediated immunosuppressive signals and fire up natural killer cells and CD8-positive lymphocytes to attack cancer cells. The development program for the drug includes a biomarker strategy for enrolling patients into clinical trials.
Biond, founded in 2016, has a pipeline of other immunotherapy products, including BION-206, which targets soluble CD28 with the goal of overcoming resistance to PD-1 blockade. The company is also developing a platform for intracellular delivery of biologic agents called INspire.