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(Boursier.com) — In huge volumes, Nanobiotix soared by nearly 50% to 6.99 euros at the start of the week. Highly anticipated, the biotech has announced the signing of a global licensing, co-development and commercialization agreement with Janssen Pharmaceutica NV (Janssen), an entity of the Janssen Pharmaceutical Companies of Johnson & Johnson group, for the product candidate NBTXR3 , potential first-in-class radioenhancer.
NBTXR3 is currently being evaluated in several studies across different solid tumor indications, including NANORAY-312, an international pivotal Phase 3 trial evaluating NBTXR3 in the treatment of patients with locally advanced head and neck squamous cell carcinoma. NBTXR3 is also being evaluated for its potential as a systemic agent in combination with anti-PD-1 immune checkpoint inhibitors in patients with metastatic cancers.
Under the terms of the license agreement and in collaboration with Johnson & Johnson’s Interventional Oncology R&D unit, Nanobiotix grants Janssen an exclusive license for the development and commercialization of NBTXR3. This license is worldwide with the exception of the territories already covered by the license agreement with LianBio, partner of Nanobiotix.
Nanobiotix will receive short-term financial and operational support worth up to $60 million. This sum includes an upfront payment of $30 million, as well as operational support for regulatory and development activities of the NANORAY-312 study of up to $30 million, which Janssen may provide at its sole discretion. .
Nanobiotix will retain operational control of NANORAY-312 and all other ongoing studies, as well as manufacturing of NBTXR3 and initial clinical and commercial supply. Janssen will be fully responsible for an initial Phase 2 study evaluating NBTXR3 in patients with stage 3 lung cancer and will have the ability to take control of studies currently being conducted by Nanobiotix.
Nanobiotix is eligible for milestone payments of up to $1.8 billion in total, tied to the achievement of development, regulatory and commercialization goals. The agreement further provides for additional milestone payments of up to $650 million tied to the achievement of development and regulatory milestones for a set of five additional indications that Janssen may develop at its sole discretion.
Finally, and in agreement with Janssen, Nanobiotix could also be eligible for additional milestone payments of up to $220 million in total for any new indication Nanobiotix develops on its own. Nanobiotix will also receive double-digit tiered-royalties on net sales of NBTXR3.
In addition, Nanobiotix is eligible to receive up to $30 million in equity investments from Johnson & Johnson Innovation – JJDC, Inc. (JJDC) through capital increases with waiver of preferential subscription rights, in two tranches: a first tranche equivalent to the lesser of $5 million or 5% of the Company’s share capital on a non-diluted basis, and a second tranche of $25 million, without JJDC being able to exceed a percentage maximum of the Company’s capital and subject to the simultaneous completion of a future fundraising.
The effective date of the licensing agreement is subject to the satisfaction of customary closing conditions including the United States antitrust review process under the Hart-Scott-Rodino Act. From the effective date of the license agreement, cash and cash equivalents will allow the Company to finance its activity until the first quarter of 2024, without taking into account development milestone payments, nor the use of the second investment tranche described above.
Portzamparc speaks of excellent news for the group, whose deal with Janssen salutes 20 years of effort. The brokerage house raises its target from 6.1 to 10.6 euros.