While Nanobiotix would maintain operational control over the ongoing clinical studies, including NANORAY-312, Janssen would reserve the right to assume control of these studies. Image Credit: Andrey_Popov / Shutterstock.

Nanobiotix has entered a global licence agreement for the development and commercialisation of its radiation sensitizer (NBTXR3) with Janssen.

Johnson & Johnson (J&J) will hold an exclusive global licence except in Greater China, Singapore, Thailand, and South Korea, where a different partner, LianBio, holds rights.

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Several studies evaluating NBTXR3 in multiple solid tumour indications are currently underway, including Nanobiotix and LianBio’s Phase III NANORAY-312 (NCT04892173), for treating patients with locally advanced head and neck cancer.

Under the licence agreement, Nanobiotix would receive $30m as an upfront cash licensing fee with an optional additional $30m for the NANORAY-312 trial’s regulatory and development support. Janssen will maintain sole discretion over the optional payment.

While Nanobiotix would maintain operational control over the ongoing clinical studies, including NANORAY-312, Janssen would reserve the right to assume control of these studies. Furthermore, Janssen will assume full responsibility for an initial Phase II study of NBTXR3 for patients with stage III lung cancer.

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Nanobiotix’s additional responsibilities include manufacturing, clinical supply, and initial commercial supply of NBTXR3. The company would also be eligible to receive aggregate payments of up to $1.8bn subject to success in developmental, regulatory, and sales milestones.

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The deal structure allows for success-based total payments of up to $650m for five new indications that Janssen can develop, and up to an aggregate of $220m for every indication that Nanobiotix develops alongside Janssen.

Nanobiotix is eligible for J&J Innovation equity investments, without preferential subscription rights, of up to $30m in two tranches. Nanobiotix expects the first tranche to extend its cash runway to the first quarter of 2024. According to Nanobiotix, the company is also in line to receive tiered “double-digit royalties” on NBTXR3’s net sales.

There has been a surge in cancer drug development with GlobalData predicting oncology drug sales to generate $2.2tn between 2023 and 2029.

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