Hensify (crystalline hafnium oxide) / Nanobiotix, LianBio, J&J - LARVOL DELTA

Re-Irradiation (Rert) With NBTXR3 for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer (NSCLC): A Phase I Trial (IASLC-WCLC 2026) - "Conclusions : NBTXR3 plus reRT is feasible and safe with promising efficacy for locoregionally recurrent NSCLC. These data compare favorably to historical controls and merit further investigation in a randomized trial."

P1 data • Cardiovascular • Gastrointestinal Disorder • Hypotension • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Final safety and HRQoL results of the phase II/III Act.In.Sarc study with preoperative NBTXR3 plus radiotherapy versus radiotherapy in locally advanced soft-tissue sarcoma. (PubMed, Int J Radiat Oncol Biol Phys) - "NBTXR3 did not negatively impact safety or HRQoL. Long-term safety results reinforce the favorable benefit-risk ratio of NBTXR3 plus radiotherapy."

Journal • P2/3 data • Musculoskeletal Diseases • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Multifunctional nanoplatforms nanomedicine-device combination products: a translational maturity framework spanning nanocoated implants, theranostic platforms, wearable nanosensors, drug-eluting devices, intratumoral nanoparticle injections, and inorganic hybrid nanoplatforms. (PubMed, Nanomedicine (Lond)) - "Using the TMF, we show that intratumoral nanoparticle injections (NBTXR3, NanoTherm) have achieved the highest translational maturity, reflecting their simple design and physics-based mechanisms that ease regulatory classification, while multifunctional theranostic and hybrid platforms face the steepest barriers due to structural complexity and dual diagnostic-therapeutic classification challenges. We identify manufacturing scalability and regulatory classification ambiguity as universal bottlenecks across all six categories, propose a regulatory decision tree for combination-pathway selection, and outline priority research directions for accelerating clinical translation. This framework gives developers, regulators, and investors a structured tool for benchmarking progress and allocating resources in this rapidly evolving field."

Journal • Review • Oncology

NANOBIOTIX Announces Complete Full Cohort Phase 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent Non-Small Cell Lung Cancer (GlobeNewswire) - "The data were presented...at the International Association for the Study of Lung Cancer ('IASLC') 2026 World Conference on Lung Cancer ('WCLC')....Results from the pooled dose-escalation and expansion phases showed that all 24 patients completed treatment with JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities....At a median follow-up of 12 months (data cutoff: August 2026) the one-year locoregional control rate was 79%. One-year local progression-free survival ('LPFS') was 61% (median 13.6 months), and one-year overall survival ('OS') was 70% (median 14.8 months). Investigators concluded that JNJ-1900 (NBTXR3) may permit clinically meaningful local control using a substantially lower re-irradiation dose."

P1 data • Non Small Cell Lung Cancer

Safety and Anti-Tumor Activity of NBTXR3/SBRT with Immune Checkpoint Inhibitors in Anti-PD-1 Resistant Melanoma: Results from a Phase I Dose Expansion (ESMO 2026) - No abstract available

Checkpoint inhibition • Clinical • P1 data • Melanoma • Oncology • Solid Tumor

Phase I study of reirradiation (ReRT) with NBTXR3 for inoperable locoregional recurrent non-small cell lung cancer (NSCLC) (ELCC 2025) - P1 | "NBTXR3 plus reRT is feasible and safe for locally recurrent NSCLC. RP2D of 33% will be used in an ongoing dose expansion phase."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Nanoray Pancreas: Biomarker Insights of NBTXR3 Activated by Radiotherapy (RT) for Locally Advanced or Borderline Resectable Pancreatic Cancer (LAPC or BRPC) (ASTRO 2026) - No abstract available

Biomarker • Metastases • Oncology • Pancreatic Cancer • Solid Tumor

Redox-modulating metallic nanoparticles: mechanistic insights into pharmacological activity and cellular therapeutics. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Although agents such as Ferumoxytol and Hensify have reached clinical application, challenges regarding long-term toxicity, immunogenicity, and systemic clearance remain. Future directions in this field emphasize the development of stimuli-responsive nanoplatforms for scientifically controlled and reproducible cargo release and the integration of computational tools to predict biological interactions. These advances are expected to provide deeper mechanistic insights into pharmacological activity at the nano-bio interface."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Infectious Disease • Movement Disorders • Oncology • Parkinson's Disease • CAT

NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Mar 2026 ➔ Mar 2028 | Trial primary completion date: Mar 2026 ➔ Mar 2028

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Nanoparticle radiosensitizers in cancer radiotherapy: bridging preclinical promise and clinical reality. (PubMed, Clin Transl Oncol) - "We then evaluate major nanoparticle classes through a translational lens, explicitly distinguishing platforms that have reached prospective clinical testing-most notably hafnium dioxide nanoparticles (NBTXR3/Hensify)-from those still confined to preclinical investigation...A comparative framework is provided to help readers assess the readiness level of different nanoplatforms. Rather than offering an exhaustive catalog of published studies, this review aims to identify critical roadblocks and prioritize research directions that can accelerate meaningful clinical deployment of nanoparticle radiosensitizers in cancer radiotherapy."

Journal • Preclinical • Review • Oncology

Beyond apoptosis: nanomedicine enabled reprogramming of tumor cell death for next-generation radiosensitization. (PubMed, J Nanobiotechnology) - "Furthermore, we discuss the clinical translation of landmark nano-radiosensitizers, such as NBTXR3 and AGuIX, while critically addressing fundamental bottlenecks in targeting efficiency, biodistribution, and biosafety. By synthesizing current trends and future perspectives, this review contributes a strategic roadmap for advancing the design of next-generation, intelligent nanoplatforms toward more precise and systemic radiosensitization."

Journal • Review • Oncology

LUMIRAY: A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | N=30 ➔ 45

Enrollment change • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Reirradiation with NBTXR3/SBRT in combination with nivolumab or pembrolizumab for the treatment of patients with recurrent or metastatic head & neck squamous cell carcinoma (HNSCC) in the phase I trial study 1100. (ASCO 2026) - P1 | "Reirradiation with NBTXR3 with SBRT and anti-PD1 was feasible in R or R+M HNSCC with an adverse effect profile expected for this clinical setting. Encouraging preliminary efficacy outcomes have been observed, thus warranting further investigation."

Clinical • Combination therapy • Metastases • P1 data • Gastrointestinal Disorder • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NCI-2020-03731: NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Suspended ➔ Active, not recruiting

Enrollment closed • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

NANOBIOTIX Announces Full Exercise of Underwriters’ Over-Allotment Option, Bringing Gross Proceeds of Offering to Approximately $100 Million (GlobeNewswire) - "The Company intends to use the net proceeds from the Global Offering, including the net proceeds from the sale of the Additional ADSs, as follows: (i) less than 10% to support the development and advancement of JNJ-1900 (NBTXR3); (ii) between 50-60% to advance our Nanoprimer and other platforms; and (iii) between 30-40% for general corporate purposes."

Financing • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

Nanobiotix Announces Presentation of Part 1 Data From a Randomized Phase 2 Clinical Trial Evaluating JNJ-1900 (NBTXR3) in Stage 3 Inoperable Lung Cancer (GlobeNewswire) - "Data presented by Johnson & Johnson at the 2026 European Society for Radiotherapy and Oncology (ESTRO) Annual Meeting....Initial efficacy responses observed in 7 patients following the full treatment regimen of concurrent chemoradiotherapy, JNJ-1900 (NBTXR3), and consolidation with durvalumab are promising: Overall response rate ('ORR') = 85.7% (6/7 patients); Complete response rate ('CRR') = 57.1% (4/7 patients); With the current standard of care, concurrent chemoradiation therapy (cCRT) ± durvalumab, depth of response remains limited in Stage 3 Inoperable NSCLC with very low rates of complete response (<5%); Disease control rate ('DCR') = 100.0% (7/7 patients)."

P2 data • Non Small Cell Lung Cancer

Nanobiotix Announces Protocol Amendment to Ongoing Global Phase 3 Head and Neck Cancer Study (GlobeNewswire) - "This protocol amendment, submitted by NANORAY-312 global sponsor Johnson & Johnson, eliminates the previously planned interim analysis and modifies the final analysis to include fewer events than originally planned and to be conducted sooner. In Nanobiotix’s view, this decision could accelerate and expand the global registration pathway for JNJ-1900 (NBTXR3) in head and neck cancer, providing the opportunity for earlier increased revenue generation for the Company. Nanobiotix anticipates that the modified final analysis should readout in the same timeframe as the previously planned interim analysis. Exact timing will depend on when clinical events occur."

Clinical protocol • Squamous Cell Carcinoma of Head and Neck

NANORAY-312: JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | Trial primary completion date: Jun 2026 ➔ Jun 2028

Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase 2, randomized, open-label, active-controlled study of JNJ-90301900 in combination with chemoradiation followed by durvalumab in locally advanced and unresectable Stage III non-small cell lung cancer (ChiCTR) - P2 | N=130 | Sponsor: Shandong First Medical University Affiliated Tumor Hospital; Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Canc

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Analysis of NBTXR3 nanoparticles recapture after release by dying cells (AACR 2024) - "Furthermore, we demonstrate in vitro that nanoparticles taken up by these tumor cells and subsequently released upon their death can be reinternalized by other tumor cells, thus facilitating their destruction by RT. These initial findings provide a deeper insight into the behavior of NBTXR3."

Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CD8

Novel intratumoral radioenhancer (JNJ-1900) with chemoradiation and consolidative immunotherapy for stage III unresectable non-small cell lung cancer (NSCLC): Early outcomes from the phase II CONVERGE study (ELCC 2026) - "Part 1 patients received a single administration of JNJ-1900 into at least one target lesion, followed by cCRT (60 Gy in 30 fractions; Carboplatin/Paclitaxel weekly for 6 weeks), and if no evidence of progressive disease (PD) per RECIST v1.1, cIT (durvalumab). Early findings are encouraging for response and safety outcomes.Editorial acknowledgement The authors thank Md. Najeeb Ashraf of SciVoc Consulting Inc, Toronto, Canada for providing writing assistance and Shefali Harankhedkar of SciVoc Consulting Inc, Toronto, Canada for editorial support."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TBX3

NANOBIOTIX…announced the presentation of first data from the CONVERGE study, a Johnson & Johnson-sponsored randomized Phase 2 clinical trial evaluating potential first-in-class Nanoradioenhancer JNJ-1900 (NBTXR3) for patients with stage 3 inoperable non-small cell lung cancer, at the 2026 European Lung Cancer Conference. (The Manila Times) - "The procedure demonstrated an acceptable safety profile without serious treatment-emergent adverse events (TEAEs) and did not adversely impact patients’ ability to continue planned therapy; Initial efficacy responses observed in 7 patients at first disease evaluation following concurrent chemoradiotherapy, and before treatment with anti-PD-L1, are promising (ORR = 71.4%; DCR = 100%) relative to the estimated benchmark (ORR = 45%-50%)."

P2 data • Non Small Cell Lung Cancer

NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Analysis of cancer cells response to radiotherapy activated NBTXR3 nanoparticles (AACR 2024) - "Upon activation by RT, NBTXR3 within lysosomes induces lysosomal membrane permeabilization (LMP), resulting in an increase in lipid peroxidation, inducing regulation of fatty acid oxidation genes, and impacting mitochondrial genes expression, such as respirasome. These findings provide a deeper insight into the early biological effects of NBTXR3+RT in comparison to RT alone."

IO biomarker • Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CD8

NCI-2020-03731: NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer (clinicaltrials.gov) - P1 | N=24 | Suspended | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Suspended

Trial suspension • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor