Nanobiotix’s lead program could offer a new way of treating head and neck cancer, and preliminary data are expected next year. The biotech’s problem is that its cash reserves were projected to dry up sometime this summer. Johnson & Johnson is throwing a lifeline, striking a deal that lands rights to the cancer therapy while giving Nanobiotix enough financial support until the readout of key data in 2024.
According to deal terms announced Monday, J&J’s Janssen subsidiary is paying a $30 million upfront licensing fee for global rights to the therapy, NBTXR3, excluding rights LianBio holds for certain regions in Asia. Janssen has also committed up to $30 million in in-kind regulatory and development support for the therapy’s Phase 3 clinical trial in head and neck cancer. Milestone payments could bring Paris-based Nanobiotix up to $1.8 billion more.
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Radiation therapy is one of the main treatments currently used for head and neck cancer. However, this radiation also damages healthy cells. The technology of Nanobiotix employs nanoparticles that once activated by radiation, serve to increase a tumor’s absorption of the radiotherapy. This approach enhances radiotherapy locally at the site of the tumor but not in surrounding tissues, potentially enabling higher doses of radiation without an increase in harm to healthy tissue.
NBTXR3 is administered as an intratumoral injection. The Phase 3 test of NBTXR3 is enrolling about 500 elderly patients with locally advanced head and neck squamous cell carcinoma. The open-label study has two groups. One group is evaluating the Nanobiotix therapy activated by radiotherapy alone or dosed in combination with cetuximab, a targeted therapy whose uses include the treatment of head and neck cancer. The comparator group is receiving the physician’s choice of radiotherapy alone or in combination with cetuximab. The main goal is to measure progression-free survival, which is how long patients live without their disease progressing or death from any cause, whichever comes first.
In its report of first quarter 2023 financial results, Nanobiotix said an analysis to assess the trial’s ability to meet its goals will be conducted in the first half of 2024 while interim safety and efficacy data are expected in the second half of the year. But Nanobiotix reported a €30.2 million (about $33.2 million) cash position as of the end of March, which the company projected would be enough to fund operations only into the third quarter of this year.
In addition to the upfront and in-kind payments, Nanobiotix could receive more in the form of equity investments from J&J. The first tranche is $5 million. A second $25 million tranche would happen in connection with a future financing. Excluding the second tranche and near-term development milestones, Nanobiotix estimates that it now has enough cash to last first quarter of 2024, when it should have some data showing how it’s therapy is working.
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“We expect this agreement, and the collaboration it enables, to further drive the expansion of NBTXR3 development and accelerate the realization of its promise for patients in need,” Nanobiotix Chief Financial Officer Bart van Rhijn said in a prepared statement. “We look forward to maximizing the value of NBTXR3 for our global stakeholders.”
Nanobiotix will maintain control of the Phase 3 test of NBTXR3 as well as all other ongoing tests of the drug. But Janssen will be responsible for a Phase 2 study evaluating the therapy as a treatment for stage three lung cancer and has the right to assume control of studies currently led by Nanobiotix.
Photo: Niels Wenstedt/BSR Agency, Getty Images
