On December 9, 2024 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, reported the completion of the dose escalation and dose expansion parts of a Phase 1 study evaluating radiotherapy("RT")-activated NBTXR3 (JNJ-1900) for patients with locally advanced pancreatic cancer ("LAPC") or borderline resectable pancreatic cancer ("BRPC") (Press release, Nanobiotix, DEC 9, 2024, View Source [SID1234648909]). The Phase 1 study is being conducted by The University of Texas MD Anderson Cancer Center ("MD Anderson").
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Patients with LAPC or BRPC often receive initial treatment with cytotoxic chemotherapy followed by RT +/- concurrent or maintenance chemotherapy.
This Phase 1 study was designed to evaluate the safety, feasibility, and early signs of efficacy of RT-activated NBTXR3 for patients with LAPC or BRPC after initial treatment with cytotoxic chemotherapy, in comparison to the historical data in patients who received RT +/- concurrent or maintenance chemotherapy after initial treatment with cytotoxic chemotherapy.
Investigators observed an mOS of 23 months from the date of diagnosis in 22 patients (20 with LAPC and 2 with BRPC) on the trial that compared favorably with outcomes at MD Anderson where the historical control for mOS in 144 patients treated at the same center was 19.2 months. Investigators concluded that RT-activated NBTXR3 was well tolerated by all patients and that the encouraging oncologic outcomes observed warrant further evaluation in a randomized trial.
Following these encouraging results from the study, MD Anderson submitted and received US FDA clearance for a new, additional study cohort evaluating the combination of NBTXR3 and standard-of-care concurrent chemoradiation. The new cohort has launched, and recruitment is ongoing.
"The results we have observed in this Phase 1 study give us confidence that NBTXR3 could have a significant impact for these patients," said Louis Kayitalire, MD, Chief Medical Officer at Nanobiotix. "We look forward to the data from the new cohort and believe the combination of NBTXR3 and concurrent chemoradiation could produce even more favorable outcomes for patients with locally advanced or borderline resectable pancreatic cancer."
Nanobiotix expects full results from the completed dose escalation and dose expansion parts of the study to be presented by MD Anderson at a medical congress in 1H 2025.
About NBTXR3
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.