Monday, July 10, 2023
Nanobiotix, a biotechnology company has announced a global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson. The agreement focuses on NBTXR3, a potential first-in-class radioenhancer, and its expansion in the field of cancer treatment.
NBTXR3 is currently being evaluated in several studies for various solid tumor indications. One notable study is NANORAY-312, a global Phase 3 pivotal study assessing NBTXR3 for the treatment of patients with locally advanced head and neck cancer. The investigational agent is also being explored for its potential in combination with anti-PD-1 immune checkpoint inhibitors as a systemic treatment option for metastatic cancers.
Under the terms of the agreement, Nanobiotix will grant Janssen a worldwide license for the development and commercialization of NBTXR3. The license is exclusive, except for territories previously licensed to Nanobiotix partner LianBio. Nanobiotix will continue to maintain operational control of NANORAY-312 and ongoing studies, as well as oversee NBTXR3 manufacture, clinical supply, and initial commercial supply. Janssen will be responsible for conducting an initial Phase 2 study for NBTXR3 in patients with stage three lung cancer and may assume control of other studies led by Nanobiotix.
As part of the agreement, Nanobiotix will receive near-term cash and operational support valued up to $60 million. This includes an upfront cash licensing fee of $30 million, as well as regulatory and development support for the NANORAY-312 study valued at up to $30 million, subject to Janssen's discretion. Nanobiotix will also be eligible for success-based payments totaling up to $1.8 billion, based on potential development, regulatory, and sales milestones. Additional milestone payments of up to $650 million for five new indications developed by Janssen and up to $220 million per indication developed by Nanobiotix in alignment with Janssen are also outlined in the agreement. Following commercialization, Nanobiotix will receive tiered double-digit royalties on net sales of NBTXR3.
In addition, Nanobiotix is eligible to receive equity investments of up to $30 million from Johnson & Johnson Innovation – JJDC, Inc., as part of capital increases without preferential subscription rights.
The agreement is subject to customary closing conditions, regulatory clearances, and approval by US antitrust authorities under the Hart-Scott-Rodino Act. The transaction is expected to become effective upon meeting these conditions.
This collaboration with Janssen is a significant step for Nanobiotix in advancing the development and expanding the potential of NBTXR3, aiming to benefit cancer patients worldwide.