Nanobiotix SA licences NBTXR3 to J&J

NBTXR3 is currently being evaluated across different solid tumour indications including NANORAY‑312, a global Phase III pivotal study in  patients with locally advanced head and neck cancer. NBTXR3 is also being evaluated for its potential as a systemic agent in combination with anti-PD‑1 immune checkpoint inhibitors for patients with metastatic cancers.

Under the terms of the license agreement, in collaboration with the Interventional Oncology R&D Unit at Johnson & Johnson, Nanobiotix will grant Janssen a worldwide license for the development and commercialization of NBTXR3. The license is exclusive, excepting territories previously licensed to Nanobiotix partner LianBio.

Nanobiotix will receive near term cash and operational support of up to US$60m including an upfront payment of US$30m and in-kind regulatory and development support for study NANORAY-312 that Janssen may provide at its sole discretion. Nanobiotix will maintain operational control of NANORAY-312 and all other currently ongoing studies, along with NBTXR3 manufacture, clinical supply, and initial commercial supply. Janssen will be fully responsible for an initial Phase II study evaluating NBTXR3 for patients with stage III lung cancer and will have the right to assume control of studies currently led by Nanobiotix.

Potential milestones sum up to US$1.8bn. Moreover, the agreement includes a framework for additional success-based potential development and regulatory milestone payments of up to $650m, in the aggregate, for five new indications that may be developed by Janssen at its sole discretion; and of up to $220m, in the aggregate, per indication that may be developed by Nanobiotix in alignment with Janssen. Following market approval, Nanobiotix will also receive tiered double-digit royalties on net sales of NBTXR3.

Separately, Nanobiotix is eligible to receive up to $30 million in equity investments from Johnson & Johnson Innovation.