Janssen will obtain an exclusive license to develop and commercialise the NBTXR3 worldwide, in exchange for up to $60m in near-term cash and operational support, in addition to $1.8bn in milestone payments, and tiered royalty on net sales
Janssen licenses NBTXR3 from Nanobiotix. (Credit: Michal Jarmoluk from Pixabay)
Janssen Pharmaceutica, a subsidiary of Johnson & Johnson (J&J), has signed an exclusive global licensing agreement with Nanobiotix for the latter’s investigational radio enhancer NBTXR3.
Under the terms of the deal, Janssen will obtain an exclusive license to develop and commercialise the NBTXR3 worldwide in collaboration with J&J’s interventional oncology R&D unit.
Nanobiotix will receive up to $60m in near-term cash and operational support, which includes an upfront cash licensing fee of $30m, and up to $30m to support the NANORAY-312 study.
The biotechnology company is also eligible to receive additional payments of up to $1.8bn, in the aggregate, contingent on achieving potential development, regulatory, and sales milestones.
In addition, the agreement includes potential development and regulatory milestone payments of up to $650m for five new indications that Janssen may develop at its sole discretion.
Also, Nanobiotix may receive up to $220m per indication that the company may develop in alliance with Janssen and tiered double-digit royalties on net sales of NBTXR3.
Separately, Nanobiotix is eligible to receive up to $30m in equity investments from Johnson & Johnson Innovation (JJDC), including an initial tranche of up to $5m and a second tranche of $25m.
The biotechnology company will maintain operational control of NANORAY-312, including its manufacturing, clinical supply, and commercial supply.
Janssen will be responsible for the initial Phase 2 study of NBTXR3 in patients with stage three lung cancer and will assume control of studies, currently being conducted by Nanobiotix.
The transaction is expected to be completed soon, subject to customary closing conditions and regulatory clearances, including the Hart-Scott-Rodino Act.
Nanobiotix executive board chairman Laurent Levy said: “As pioneers in the field of nanotherapeutics for the past 20 years, we knew that the true impact of our innovation in oncology would be in its potential to reach millions of patients around the world.
“For that, we needed to find the right partner, at the right time, with proven global development and commercialisation capabilities.
“We are delighted to collaborate with Janssen as we aim to improve the lives of patients with cancer around the world.”
Established in 2003, Nanobiotix is engaged in developing physics-based radio-therapeutic approaches for cancer.
The company currently holds more than 20 patents covering three nanotechnology platforms, bioavailability and biodistribution, and central nervous system (CNS) disorders.
Its lead candidate NBTXR3 is currently being evaluated in several studies across solid tumour indications, including the Phase 3 NANORAY-312 study in advanced head and neck cancer.
The drug is also being studied in combination with anti-PD-1 immune checkpoint inhibitors to unlock its potential as a systemic agent for the treatment of patients with metastatic cancers.
Nanobiotix chief financial officer Bart van Rhijn said: “We expect this agreement, and the collaboration it enables, to further drive the expansion of NBTXR3 development and accelerate the realisation of its promise for patients in need.”