J&J's Janssen Pharmaceutical has signed a global licensing, co-development and commercialization deal that could fetch as much as $1.8 billion with Paris-based Nanobiotix for the investigational, potential first-in-class radioenhancer, NBTXR3.
Nanobiotix's lead product, NBTXR3 is currently being evaluated in several studies across solid tumor indications including NANORAY-312, a global phase 3 pivotal study for the treatment of patients with locally advanced head and neck cancer. It 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.
The radioenhancer already nabbed market authorization back in 2019 in Europe for the treatment of patients with soft tissue sarcoma, under the brand name Hensify. Hensify is an aqueous suspension of crystalline hafnium oxide nanoparticles designed for injection directly into a tumor prior to a patient’s first standard radiotherapy treatment. When exposed to ionizing radiation, the treatment amplifies the localized, intratumor killing effect of that radiation. The dose of X-ray delivered to the tumor is magnified, whilst the dose passing through healthy tissues remains unchanged.
Back in May, Nanobiotix had shared that it was in "final contract negotiations" with a "major global pharmaceutical company" for NBTXR3 and has now revealed that company to be Janssen.
The deal includes an upfront cash licensing fee of $30 million, and in-kind regulatory and development support for study NANORAY-312 valued at up to $30 million 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 responsible for an initial phase 2 study evaluating NBTXR3 for patients with stage three lung cancer and will have the right to assume control of studies currently led by Nanobiotix.
Nanobiotix is also eligible for success-based payments of up to $1.8 billion.
Additionally, the agreement includes a framework for additional success-based potential development and regulatory milestone payments of up to $650 million for five new indications that may be developed by Janssen and of up to $220 million per indication that may be developed by Nanobiotix in alignment with Janssen.