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

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) - No abstract available

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

Intratumoral Radioenhancer Nanoparticle NBTXR3 Followed by Radiotherapy in Head and Neck Cancer: A Phase 1 Dose-Expansion Nonrandomized Clinical Trial. (PubMed, JAMA Otolaryngol Head Neck Surg) - P1 | "This dose-expansion phase 1 nonrandomized clinical trial demonstrated that intratumoral NBTXR3 followed by RT in a high-risk patient population unable to receive cisplatin or cetuximab was feasible and had a preliminary efficacy signal that supports a benefit-risk profile being evaluated in an ongoing randomized phase III trial. ClinicalTrials.gov Identifier: NCT01946867."

Clinical • Journal • P1 data • Dental Disorders • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Stomatitis

Engineering Hafnium Oxide-Based Nanoplatforms for Precision Radiosensitization. (PubMed, Adv Healthc Mater) - "This review traces the development of HfO2 nanoradiosensitizers, starting with the clinically established NBTXR3, an approved hafnium-based benchmark for several solid tumors...Future directions point toward smart stimuli-responsive platforms and multimodal theranostic systems. This review highlights the potential of HfO2 to precision radiotherapy while acknowledging existing translational challenges."

Journal • Review • Immunology • Oncology • Solid Tumor

NBTXR3, Radiation Therapy, and Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer (clinicaltrials.gov) - P2 | N=14 | Terminated | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2026 ➔ Jan 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2026 ➔ Jan 2026; <75% participation

IO biomarker • Trial completion date • Trial primary completion date • Trial termination • Head and Neck Cancer • Lung Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

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

Radioenhancing Hafnium Oxide Nanoparticles (NBTXR3) Followed by Stereotactic Body Radiation Therapy in Patients With Hepatocellular Carcinoma and Liver Metastases (NBTXR3-103): Phase 1 Dose-Escalation Trial. (PubMed, Adv Radiat Oncol) - "The RP2D for treatment of HCC or liver metastases is 42% of GTV. Future studies will further evaluate efficacy."

Journal • P1 data • Fatigue • Hematological Disorders • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Pain • Solid Tumor

Multimodal synergistic effects and theranostic integration of hafnium-based nanoradiosensitizers for enhancing precision radiotherapy. (PubMed, Biomaterials) - "While clinical candidates like NBTXR3 exhibit promising trial outcomes, challenges remain in mechanistic clarification, biocompatibility optimization, and controlled in vivo degradation. Emerging AI-driven design and multidisciplinary integration hold promise to expedite clinical translation, advancing Hf-based radiosensitizers toward intelligent, personalized cancer therapy paradigms. This work highlights Hf's critical role in redefining precision radiotherapy and delineates a roadmap for next-generation oncological intervention."

Journal • Review • Oncology

The radioenhancer NBTXR3: bridging physics and biology to improve radiotherapy outcomes and prime anti-tumor immunity. (PubMed, J Exp Clin Cancer Res) - "Beyond better cancer cell destruction and tumor control, radiotherapy-activated NBTXR3 nanoparticles can also stimulate systemic antitumor immune responses in preclinical models. This review aims to provide a comprehensive analysis of preclinical research on NBTXR3, focusing on its mechanism of action and role in initiating and enhancing antitumor immune responses."

Journal • Review • Oncology

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 completion date: Dec 2027 ➔ Jun 2028

Trial completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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=30 | Recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | Not yet recruiting ➔ Recruiting

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

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 | Recruiting ➔ Active, not recruiting | N=24 ➔ 34

Enrollment change • Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study 1100: NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy (clinicaltrials.gov) - P1 | N=145 | Active, not recruiting | Sponsor: Nanobiotix | Recruiting ➔ Active, not recruiting | Trial completion date: May 2028 ➔ Aug 2027

Enrollment closed • Trial completion date • Bladder Cancer • Breast Cancer • Cervical Cancer • Dermatology • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Endoscopic Ultrasound-Guided Injection of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Esophageal Adenocarcinoma: Interim Analysis of Feasibility and Safety (ACG 2025) - "Only one patient each was treated at 15% and 22%, with 7 treated at 33% of the GTV, a total of 9 patients were enrolled (Table 1). There were no periprocedural adverse events (AEs) during EUS-FNI. All patients completed CRT without any toxicity that could be specifically attributable to R3."

Clinical • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Solid Tumor

NANOBIOTIX Announces Strategic Royalty Monetization Agreement With Healthcare Royalty for up to $71 Million and Extends Cash Runway Toward Long-Term Growth (The Manila Times) - "$71 million in funding would extend Nanobiotix cash visibility into early 2028....HealthCare Royalty (HCRx) will receive a capped portion of milestones and royalties on sales of JNJ-1900 (NBTXR3) payable to Nanobiotix under its global licensing agreement....The Company continues to expect to receive the first potential milestone payments related to clinical development in head and neck cancer (NANORAY-312) and lung cancer (CONVERGE) within this timeframe, and has thereby established the financial foundation for self-sustaining long-term growth."

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

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=30 | Not yet recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc.

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Oct 2025 ➔ Oct 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2027

Trial completion date • Trial primary completion date • Cervical Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • Thoracic Cancer

NANOBIOTIX Announces First Data From Phase 1 Study Evaluating JNJ-1900 (NBTXR3) for Patients With Esophageal Cancer (GlobeNewswire) - "Treatment was well-tolerated and injection feasibility was confirmed in 13 patients with locally advanced adenocarcinoma of the esophagus. 85% (11/13) disease control rate (DCR). 69% (9/13) objective response rate (ORR); 6 complete responses and 3 partial responses. Recruitment of 17 additional patients is ongoing as planned. Data presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) on October 1st."

P1 data • Esophageal Cancer

NANOBIOTIX Announces Updated Phase 1 Results Continuing to Support JNJ-1900 (NBTXR3) Plus Anti-PD-1 as a Potential New 1L or 2L+ Option in Anti-PD-1 Naïve or Resistant R/M-HNSCC (GlobeNewswire) - "Data presented as a 'Top-rated Abstract in Head and Neck Cancer' at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO)....63% (26/41) disease control rate ('DCR') and 37% (15/41) objective response rate ('ORR') in evaluable anti-PD-1 naïve patients per RECIST 1.1; 74% (37/50) DCR and 32% (16/50) ORR in evaluable anti-PD-1 resistant patients per RECIST 1.1; 15.5 months median Overall Survival ('mOS') in evaluable anti-PD-1 naïve patients."

P1 data • Squamous Cell Carcinoma of Head and Neck

Endoscopic Ultrasound Fine Needle Injection of NBTXR3 Activated by Radiotherapy with Concurrent Chemotherapy for Adenocarcinoma of the Esophagus: Feasibility and Safety of the Phase I Dose Escalation Part for the Photon-Based Cohort (ASTRO 2025) - "In this first cohort of 9 photon treated patients with EADC, the RP2D is 33%, without safety concerns, and no periprocedural or delayed adverse events were noted. Initial clinical response and outcomes are promising. The study continues accrual for the proton cohort."

Clinical • P1 data • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Squamous Cell Carcinoma

Phase I Dose Escalation/Dose Expansion Trial of NBTXR3/SBRT in Combination with Nivolumab or Pembrolizumab for the Treatment of anti-PD-1 Naïve or Resistant Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (ASTRO 2025) - P1 | "Use of NBTXR3 when combined with SBRT and anti PD-1 was both feasible and well tolerated in patients with R/M HNSCC. These data compare favorably to historical controls and merit further investigation in randomized trials in this population."

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

NANOBIOTIX Announces New Results From a Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Combination With Immune Checkpoint Inhibitors as a 2L+ Therapy for Patients With Primary Cutaneous Melanoma Resistant to Anti-PD-1 (GlobeNewswire) - "Recommended phase 2 dose (RP2D) established at 33% of gross tumor volume (GTV). 47.4% (9/19) best observed objective response rate (ORR) in all lesions per RECIST 1.1. 78.9% (15/19) best observed disease control rate (DCR) in all lesions per RECIST 1.1. 14.6 months median Overall Survival (mOS) in all patients treated (n=21)....Data presented on September 17 at the 2025 Immunorad Conference."

P1 data • Cutaneous Melanoma

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 completion date: Jun 2027 ➔ Dec 2027

Trial completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NANOBIOTIX Announces Regulatory Harmonization and New Composition of Matter Patent Filed for JNJ-1900 (NBTXR3) (GlobeNewswire) - "NANOBIOTIX...announced two important developments that aim to reinforce the global positioning of potential first-in-class radioenhancer JNJ-1900 (NBTXR3), which is licensed by Janssen Pharmaceutica NV....Health authorities in major European countries have agreed to formally reclassify JNJ-1900 (NBTXR3) from a medical device to a drug, completing a process initiated by Johnson & Johnson to harmonize the product candidate’s regulatory status with classifications already in place in the United States and other major markets. The reclassification follows updated insights into the product candidate’s mechanism of action. In parallel, Nanobiotix has filed a new composition of matter patent for JNJ-1900 (NBTXR3) that aims to reinforce the intellectual property foundation supporting the product candidate."

Patent • Regulatory • Solid Tumor

NBTXR3, Radiation Therapy, and Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer (clinicaltrials.gov) - P2 | N=14 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | N=60 ➔ 14 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • IO biomarker • Head and Neck Cancer • Lung Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1