Nanobiotix Transfers US Sponsorship of NANORAY-312 to Janssen, Anticipates Key Data Readouts
核心洞察
Nanobiotix transferred the US sponsorship of the Phase 3 NANORAY-312 head and neck cancer (搜索) study to Janssen, a key step for NBTXR3 regulatory submission.
The company reported €53.2 million in cash and equivalents as of September 30, 2024, funding operations into Q4 2025.
Updates on NBTXR3 in pancreatic and lung cancer (搜索) studies with MD Anderson are expected in Q4 2024 and 1H 2025, respectively.
Nanobiotix (NBTX) has announced the transfer of US sponsorship for its global Phase 3 NANORAY-312 study in head and neck cancer (搜索) to Janssen Pharmaceutica NV, a Johnson & Johnson company. This move marks a significant step toward the potential regulatory submission of NBTXR3, Nanobiotix's lead product candidate. The company also reported a solid financial position with €53.2 million in cash and cash equivalents as of September 30, 2024, which is expected to sustain operations into the fourth quarter of 2025.
NANORAY-312 Sponsorship Transfer
The transfer of the NANORAY-312 study sponsorship to Janssen is a strategic move that will allow Janssen, as the global licensee for NBTXR3, to submit the drug for global registration should the trial yield positive results. NANORAY-312 is a randomized, Phase 3 study evaluating radiotherapy-activated NBTXR3 in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are ineligible for cisplatin-based chemotherapy. Nanobiotix estimates the full global sponsorship transfer will take several quarters to complete. An interim analysis is projected for the first half of 2026, contingent upon reaching the required number of events and completing patient recruitment.
Upcoming Data and Milestones
Nanobiotix anticipates several key data readouts and milestones in the near future. Updated Phase 1b dose escalation data for NBTXR3 in pancreatic cancer (搜索) from the MD Anderson Cancer Center collaboration is expected in the fourth quarter of 2024. Initial Phase 1 dose escalation data in inoperable, recurrent non-small cell lung cancer (搜索) (NSCLC (搜索)) amenable to re-irradiation is anticipated in the first half of 2025. Additionally, the company plans to present initial Phase 1b/2 data for NBTXR3 in esophageal cancer (搜索) in 2025.
Supervisory Board Expansion
To bolster its long-term growth strategy, Nanobiotix has appointed Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers to its Supervisory Board. Dr. Liu brings extensive experience in academia, pharmaceuticals, biotechnology, and public policy, while Ms. Naschitz offers expertise in capital allocation for disruptive innovation.
NBTXR3: A Novel Approach to Cancer Therapy
NBTXR3 is a first-in-class oncology product composed of functionalized hafnium oxide nanoparticles. Administered via intratumoral injection and activated by radiotherapy, NBTXR3 is designed to induce significant tumor cell death, subsequently triggering adaptive immune responses and long-term anti-cancer memory. The physical mechanism of action allows NBTXR3 to be potentially scalable across any solid tumor treatable with radiotherapy and across therapeutic combinations, including immune checkpoint inhibitors. The FDA has granted Fast Track designation for NBTXR3 in locally advanced HNSCC patients ineligible for platinum-based chemotherapy.
Curadigm Nanoprimer Platform
Nanobiotix is also advancing its Curadigm nanoprimer platform, with an update expected in the fourth quarter of 2024. This platform aims to redefine the discovery and design of next-generation therapies by enhancing drug bioavailability and biodistribution.