NANOBIOTIX Announces Complete Full Cohort Phase 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent Non-Small Cell Lung Cancer

Phase 1 data for NBTXR3 in recurrent NSCLC show encouraging local control and survival with no dose-limiting toxicities, guiding a Phase 2 dose.

Rhea-AI Summary

Nanobiotix (NBTX) reported complete Phase 1 full-cohort results for radiotherapy-activated JNJ-1900 (NBTXR3) in 24 patients with inoperable, locoregionally recurrent non-small cell lung cancer eligible for re-irradiation.

All 24 patients completed JNJ-1900 plus re-irradiation with no dose-limiting toxicities and no Grade 3 or higher adverse events related to JNJ-1900 or the injection procedure. Grade 3 radiotherapy-related adverse events occurred in 33% of patients and Grade 5 radiotherapy-related events in 8%. The recommended Phase 2 dose was set at 33% of gross tumor volume.

At a median 12‑month follow-up (data cutoff August 2026), one-year locoregional control was 79%, one-year local progression-free survival was 61% (median 13.6 months), and one-year overall survival was 70% (median 14.8 months). Investigators concluded that JNJ-1900 may enable clinically meaningful local control at substantially lower re-irradiation doses, and additional enrollment in this trial is planned.

Positive

• 24/24 patients completed JNJ-1900 plus re-irradiation with no dose-limiting toxicities
• No Grade ≥3 adverse events related to JNJ-1900 or injection procedure in 24 patients
• One-year locoregional control 79% at median 12‑month follow-up
• One-year LPFS 61%, median 13.6 months
• One-year overall survival 70%, median 14.8 months
• Recommended Phase 2 dose defined as 33% of gross tumor volume

Negative

• Grade 3 radiotherapy-related adverse events in 33% of patients (8 of 24)
• Grade 5 radiotherapy-related adverse events in 8% of patients (2 of 24)

News Explained

Nanobiotix has completed enrollment in the study’s protocol-defined dose-escalation and expansion phases, but plans to enroll additional patients, so the 24-patient results mark a completed phase rather than the end of the study.

Market Context

The March 30 Phase 2 NSCLC update recorded a 2.1% 24-hour reaction and reported earlier JNJ-1900 res...

Analysis

The March 30 Phase 2 NSCLC update recorded a 2.1% 24-hour reaction and reported earlier JNJ-1900 response data, providing a same-drug NSCLC comparator for this full-cohort Phase 1 re-irradiation readout.

Key Figures

Treated patients: 24 patients Dose-limiting toxicities: 0 Grade 3 radiotherapy adverse events: 33% (n=8) +5 more

Treated patients

24 patients

Completed Phase 1 treatment

Dose-limiting toxicities

0

JNJ-1900 plus re-irradiation

Grade 3 radiotherapy adverse events

33% (n=8)

Radiotherapy-related events

Grade 5 radiotherapy adverse events

8% (n=2)

Radiotherapy-related events

Recommended Phase 2 dose

33% of gross tumor volume

JNJ-1900 dose recommendation

Locoregional control

79%

One-year rate; median follow-up 12 months

Local progression-free survival

61% (median 13.6 months)

One-year LPFS

Overall survival

70% (median 14.8 months)

One-year OS

Previous Clinical trial Reports

2 past events · Latest: May 17

Same Type 2 events

1. May 17

   Phase 2 clinical data

   24h Move

   +0.0%

   Early CONVERGE NSCLC data reported 85.7% ORR and 100% DCR in seven patients

2. Mar 30

   Phase 2 clinical data

   24h Move

   +2.1%

   Initial CONVERGE NSCLC data showed 71.4% ORR and 100% DCR

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

dose-limiting toxicities, locoregional control, local progression-free survival, overall survival, +2 more

6 terms

dose-limiting toxicities medical

"all 24 patients completed treatment with JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

locoregional control medical

"the one-year locoregional control rate was 79%"

A measure used in cancer care and clinical trials that describes how well treatment prevents a tumor and the nearby lymph nodes or tissues from growing or returning in the same area. Think of it like keeping weeds from reappearing in a specific part of a garden: locoregional control shows whether the problem is contained locally rather than spreading elsewhere. It matters to investors because strong locoregional control can indicate a therapy’s clinical benefit, affect regulatory decisions, label claims, and influence commercial prospects.

local progression-free survival medical

"One-year local progression-free survival (“LPFS”) was 61%"

Time from the start of treatment or trial enrollment until the cancer visibly worsens at the original (local) tumor site or the patient dies; occurrences of new tumors elsewhere are not the primary event unless the original site progresses. It matters to investors because it measures how well a therapy or procedure controls disease at the targeted location, which can influence trial success, regulatory decisions, and commercial value—think of it like how long a repaired roof stays leak-free.

overall survival medical

"one-year overall survival (“OS”) was 70%"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

re-irradiation medical

"using a substantially lower re-irradiation dose"

Re-irradiation is the medical practice of giving a second course of radiation therapy to a patient who previously received radiation to the same or an overlapping body area. It matters to investors because it represents a distinct clinical challenge and market niche—devices, planning software, and drugs that enable safer repeat dosing can affect treatment options, trial designs, regulatory review, reimbursement, and commercial opportunity in oncology care.

gross tumor volume medical

"33% of gross tumor volume"

Gross tumor volume (GTV) is the portion of a cancer that can be seen or felt by doctors using imaging tests or physical examination; it represents the visible, measurable mass of tumor before any treatment. Think of it as the outline of what doctors can directly detect when planning therapy. GTV matters to investors because it is used to set trial eligibility, measure tumor response, and guide treatment dosing or radiation targeting—factors that can affect clinical outcomes and regulatory assessments.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• All 24 patients completed treatment with no dose-limiting toxicities, no Grade 3 or higher adverse events related to JNJ-1900 (NBTXR3 or to the injection procedure, and intratumoral injection was deemed feasible
• One-year locoregional control rate was 79%, one-year local progression-free survival (LPFS) was 61%, and one-year overall survival (OS) was 70% in evaluable subjects— achieved at a lower re-irradiation dose than patients’ prior course of radiotherapy
• Investigators concluded that JNJ-1900 (NBTXR3 may permit clinically meaningful local control using a substantially lower re-irradiation dose than patients’ prior course of radiotherapy
• Enrollment in the dose-escalation and expansion parts of the study is complete per protocol; following the encourage findings, additional patient enrollment in this study is planned

Data presented at the IASLC 2026 World Conference on Lung Cancer

PARIS and CAMBRIDGE, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced updated safety and efficacy data from the completed dose-escalation and expansion phases of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center (“UT MD Anderson”) evaluating radiotherapy-activated JNJ-1900 (NBTXR3) for patients with inoperable, locoregionally recurrent non-small cell lung cancer (“NSCLC”) amenable to re-irradiation (“reRT”). The data were presented by study principal investigator Saumil Gandhi, MD, PhD, at the International Association for the Study of Lung Cancer (“IASLC”) 2026 World Conference on Lung Cancer (“WCLC”), taking place September 12–15, 2026 in Seoul, Republic of Korea.

POSTER P2.260: Re-irradiation (ReRT) with NBTXR3 for Inoperable Locoregionally Recurrent Non-Small Cell Lung Cancer (NSCLC): A Phase I Trial

Saumil N. Gandhi, MD, PhD; Enoch Chang, MD; Aileen B. Chen, MD; Stephen G. Chun, MD; Joe Y. Chang, MD, PhD; Steven H. Lin, MD, PhD; Matthew S. Ning, MD, MPH; David Qian, MD; Julianna K. Bronk, MD, PhD; Rahul A. Sheth, MD; Jianjun Zhang, MD, PhD; Tina Cascone, MD, PhD; Marcelo Vailati Negrao, MD; Anne S. Tsao, MD; George R. Blumenschein, MD; Mehmet Altan, MD; John V. Heymach, MD, PhD; James W. Welsh, MD; Suyu Liu, PhD; Zhongxing Liao, MD; Roberto F. Casal, MD — The University of Texas MD Anderson Cancer Center

Patients who are candidates for re-irradiation are frequently limited to palliative radiation doses because of normal-tissue tolerance, and their recurrent tumors typically harbor the most radiation-resistant cells. Effective strategies to safely deliver radiotherapy doses capable of controlling recurrent tumors remain a significant unmet need in this setting.

“Recurrence within a previously irradiated field is one of the least forgiving problems in thoracic oncology,” said Saumil Gandhi, MD, PhD, Department of Thoracic Radiation Oncology, Division of Radiation Oncology at UT MD Anderson. “The normal tissue near the tumor has already received a full course of radiation, so the dose that can delivered safely during a second course is limited. Additionally, the disease that returns is often more radioresistant because it survived radiation the first time. In this study, JNJ-1900 (NBTXR3) was delivered without dose-limiting toxicities, and we observed clinically meaningful local control at a substantially lower re-irradiation dose. These findings warrant evaluation in a randomized trial.”

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. Investigators reported no Grade 3 or higher adverse events related to JNJ-1900 (NBTXR3) or to the injection procedure.

Grade 3 radiotherapy-related adverse events occurred in 33% of patients (n=8), and Grade 5 radiotherapy-related adverse events in 8% (n=2). The recommended Phase 2 dose was established at 33% of gross tumor volume.

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.

“The Nanobiotix team is encouraged by these full-cohort findings in one of the most difficult settings in lung cancer,” said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. “If a physics-based approach can improve local control in tissue that has already failed radiation, and do so at a reduced dose, then the conditions in earlier settings, where full-dose radiotherapy reaches previously untreated tissue, could be even more favorable. We look forward to further evaluation in additional patients enrolled to this study and across indications.”

Enrollment in both the dose-escalation and expansion parts of the study is complete per protocol. Following the encouraging findings, additional patient enrollment in this study is planned.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s 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. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma study sponsored by Nanobiotix in 2018.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. 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 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.

In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies being led by Johnson & Johnson include NANORAY-312 (NCT04892173), a global, randomized Phase 3 study in platinum-based chemotherapy-ineligible, locally advanced head and neck squamous cell cancers; LUMIRAY (NCT07219212), a global, phase 1b, open-label study in locally advanced head and neck squamous cell cancers; and CONVERGE (NCT06667908), a phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III non-small cell lung cancer (NSCLC).

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 30 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

Disclaimer

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 2, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 2, 2025 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2025 which are available on the SEC’s website at www.sec.gov and on the AMF’s website at www.amf.org, The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly.

Nanobiotix
Communications Department Brandon Owens VP, Communications +1 (617) 852-4835 contact@nanobiotix.com	Investor Relations Department Joanne Choi VP, Investor Relations (US) +1 (713) 609-3150 joanne.choi@nanobiotix.com  Ricky Bhajun Director, Investor Relations (EU) +33 (0) 79 97 29 99 investors@nanobiotix.com
Media Relations
France – HARDY Caroline Hardy +33 06 70 33 49 50 carolinehardy@outlook.fr	Global – uncapped Becky Lauer +1 (646) 286-0057 uncappednanobiotix@uncappedcommunications.com

Attachment

• PR_MDA_NSCLC_ReRT_WCLC_2026__VF

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What patient population was enrolled in this JNJ-1900 (NBTXR3) Phase 1 study?

The trial enrolled patients with inoperable, locoregionally recurrent non-small cell lung cancer who were amenable to re-irradiation. These patients had disease recurring within a previously irradiated field, where normal tissue has already received a full course of radiation and tumors are often more radioresistant.

Who sponsored and conducted the Phase 1 JNJ-1900 (NBTXR3) re-irradiation study?

The Phase 1 study was sponsored by The University of Texas MD Anderson Cancer Center, with data presented by principal investigator Saumil Gandhi, MD, PhD, at the IASLC 2026 World Conference on Lung Cancer.

What is the proposed mechanism of action of JNJ-1900 (NBTXR3)?

JNJ-1900 (NBTXR3) consists of functionalized hafnium oxide nanoparticles given as a one-time intratumoral injection and activated by radiotherapy. The mechanism of action is designed to enhance tumor cell death in the injected lesion when activated by radiation, potentially triggering an adaptive immune response and long-term anti-cancer memory.

What regulatory status does NBTXR3 currently have in the United States?

In February 2020, the U.S. Food and Drug Administration granted Fast Track designation for investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for patients with locally advanced head and neck squamous cell carcinoma who are not eligible for platinum-based chemotherapy.

How is JNJ-1900 (NBTXR3) being developed in partnership with Johnson & Johnson?

In 2023, Nanobiotix entered a license agreement with Janssen Pharmaceutica NV for global development and commercialization of JNJ-1900 (NBTXR3). Studies led by Johnson & Johnson include NANORAY-312 in locally advanced head and neck cancers, LUMIRAY in head and neck cancers, and CONVERGE, a Phase 2 randomized study in locally advanced, unresectable Stage III NSCLC.

What are the next steps for this Phase 1 re-irradiation trial with JNJ-1900?

Enrollment in the dose-escalation and expansion parts of the trial is complete per protocol. Following the encouraging findings, additional patient enrollment in this study is planned, and investigators stated that the results warrant evaluation in a randomized trial.