On May 21, 2025 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an update on operational progress and announced financial results for the first quarter of 2025 (Press release, Nanobiotix, MAY 21, 2025, View Source [SID1234653271]).
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"We are pleased with the execution across the JNJ-1900 (NBTXR3) development programs and are excited for the important milestones ahead. NANORAY-312 continues to advance in head and neck cancer, with our ongoing global transfer of sponsorship moving toward completion, and the recent expansion of development into lung cancer through the CONVERGE study. We were also pleased by the updated clinical data further supporting expansion into indications including lung cancer amenable to re-irradiation recently presented by MD Anderson at ESTRO and ELCC, respectively and locally advanced or borderline resectable pancreatic cancer," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board.
Operational Highlights
Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE)
First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer ("NSCLC") in 1Q2025
NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson)
Presented first data showing a favorable safety profile and early signals of efficacy from the completed dose escalation part of a Phase 1 study evaluating radiotherapy-activated JNJ-1900 (NBTXR3) as a second or later line (2L+) therapy at the 2025 European Lung Cancer Conference (ELCC).
Amendment to global licensing agreement for JNJ-1900 (NBTXR3) extended cash runway to mid-2026 with a meaningful reduction in cash burn expected moving forward
Removed the vast majority of the funding obligation for NANORAY-312 and released Johnson & Johnson from select future potential milestone payments, while safeguarding hundreds of millions in potential milestone and royalty payments for lead programs for Nanobiotix
Subsequent events
Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson"))
Presented full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) demonstrating encouraging oncologic outcomes and a favorable safety profile supporting further exploration in a randomized study at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025)
Recruitment ongoing in new cohort evaluating JNJ-1900 (NBTXR3) combined with standard-of-care chemotherapy followed by concurrent chemoradiation ("CCRT" – with capecitabine or 5-FU) with first patient already injected
First Quarter Financial Updates
Cash and Cash Equivalents: based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €39.8 million as of March 31, 2025, will fund its operations into mid-2026.
About JNJ-1900 (NBTXR3)
JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.
Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.