PARIS, France and CAMBRIDGE, MA, USA I January 21, 2025 I NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced that the first patient has been dosed in the CONVERGE study, a Phase 2 randomized controlled clinical trial evaluating potential first-in-class radioenhancer JNJ-1900 (NBTXR3) for the treatment of patients with Stage 3 unresectable non-small cell lung cancer receiving standard of care chemoradiation followed by consolidation durvalumab (NCT06667908). CONVERGE is sponsored by Janssen Pharmaceutica NV, a Johnson & Johnson Company, under a global license agreement.
“We believe the true value of JNJ-1900 (NBTXR3) is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment,” said Laurent Levy, Nanobiotix Chief Executive Officer and Chairman of the Executive Board. “With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in non-small cell lung cancer brings us another step closer to delivering for the large number of patients JNJ-1900 (NBTXR3) is designed to serve.”
About 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 for which the product received a European CE mark in 2019. 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 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 NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in 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 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 NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson Company.
About NANOBIOTIX
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.
Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.
For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter
SOURCE: Nanobiotix
Post Views: 117
PARIS, France and CAMBRIDGE, MA, USA I January 21, 2025 I NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced that the first patient has been dosed in the CONVERGE study, a Phase 2 randomized controlled clinical trial evaluating potential first-in-class radioenhancer JNJ-1900 (NBTXR3) for the treatment of patients with Stage 3 unresectable non-small cell lung cancer receiving standard of care chemoradiation followed by consolidation durvalumab (NCT06667908). CONVERGE is sponsored by Janssen Pharmaceutica NV, a Johnson & Johnson Company, under a global license agreement.
“We believe the true value of JNJ-1900 (NBTXR3) is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment,” said Laurent Levy, Nanobiotix Chief Executive Officer and Chairman of the Executive Board. “With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in non-small cell lung cancer brings us another step closer to delivering for the large number of patients JNJ-1900 (NBTXR3) is designed to serve.”
About 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 for which the product received a European CE mark in 2019. 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 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 NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in 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 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 NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson Company.
About NANOBIOTIX
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.
Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.
For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter
SOURCE: Nanobiotix
Post Views: 117
