NANOBIOTIX Announces Final Data from Phase 1 Study Evaluating JNJ-1900 (NBTXR3) With Immune Checkpoint Inhibitors as a 2L+ Therapy in Anti-PD-1-Resistant Primary Cutaneous Melanoma

Responses were observed in both injected and non-injected lesions, but the preliminary findings require further evaluation in randomized trials.

Rhea-AI Summary

Nanobiotix (NBTX) announced Phase 1 melanoma results showing a 41.7% overall response rate with JNJ-1900 (NBTXR3), radiotherapy and immune checkpoint inhibitors.

The analysis included 24 heavily pre-treated patients with advanced primary cutaneous melanoma resistant to anti-PD-1 therapy. Ten patients responded, including four complete responses; disease control reached 75% (18/24). Median progression-free survival was 6.9 months, and median overall survival was 17.8 months. Responses occurred in injected and non-injected lesions. Investigators considered the safety profile acceptable; no new safety signals were observed.

These preliminary results came from a single-arm study, without a comparison group. An exploratory analysis in eight patients found IL-1β had the largest increase among measured plasma cytokines. Investigators concluded that the findings warrant further evaluation in randomized trials.

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointOverall response rate reached 41.7% (10/24), including four complete responses in heavily pre-treated, anti-PD-1-resistant melanoma patients.
• Minor pointDisease control reached 75% (18/24) in the melanoma cohort.
• Minor pointMedian overall survival reached 17.8 months; median progression-free survival was 6.9 months.
• Minor pointInjected-lesion response rate was 45.8% (11/24 evaluable patients), versus 30.0% (3/10 evaluable patients) in non-injected lesions.
• Minor pointNo new safety signals were observed; investigators considered the safety profile acceptable.
• Minor pointInjection followed by radiotherapy was feasible across a wide range of melanoma lesion sizes and locations.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.Preliminary, single-arm results in 24 patients require further evaluation in larger randomized trials, investigators concluded.

Key Figures

Study population: 24 patients Overall response rate: 41.7% (10/24) Complete responses: 4 +5 more

Study population

24 patients

Heavily pre-treated patients with advanced primary cutaneous melanoma

Overall response rate

41.7% (10/24)

Phase 1 study

Complete responses

4

Among the 24 patients

Disease control rate

75% (18/24)

Phase 1 study

Median progression-free survival

6.9 months

Phase 1 study

Median overall survival

17.8 months

Phase 1 study

Injected-lesion overall response rate

45.8% (11/24 evaluable patients)

Injected lesions

Non-injected-lesion overall response rate

30.0% (3/10 evaluable patients)

Non-injected lesions

Previous Clinical trial Reports

1 past event · Latest: Sep 14

Same Type 1 event

1. Sep 14

   Phase 1 results

   24h Move

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   Full-cohort JNJ-1900 results in recurrent NSCLC reported safety and survival outcomes.

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

Key Terms

recist 1.1, overall response rate, disease control rate, stereotactic body radiotherapy

4 terms

recist 1.1 medical

"overall response rate (ORR) per RECIST 1.1"

RECIST 1.1 is a standardized set of rules used in cancer clinical trials to measure how solid tumors respond to treatment by tracking changes in size on medical scans. Think of it as a consistent ruler and scorecard that tells doctors and regulators whether a drug is shrinking tumors, keeping them stable, or allowing them to grow. Investors care because RECIST-based results are common primary endpoints that influence regulatory decisions, trial success, and a therapy’s commercial prospects.

overall response rate medical

"An Overall Response Rate (ORR) of 41.7% (10/24 patients) was observed."

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

disease control rate medical

"75% (18/24) disease control rate (DCR)"

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

stereotactic body radiotherapy medical

"followed by stereotactic body radiotherapy (“SBRT”)"

A targeted radiation treatment that delivers very high doses of radiation to a small tumor area in the body with sub-millimeter precision, often over one to five sessions. Think of it as a precision knife that focuses energy on a single spot while sparing nearby healthy tissue. It matters to investors because its use, clinical results, regulatory approvals, and related equipment or software sales can influence healthcare company revenues and market value.

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• In 24 heavily pre-treated patients with advanced primary cutaneous melanoma whose cancer had progressed after multiple prior lines of therapy including anti-PD-1 therapy, data continue to show an acceptable safety profile and early signals of efficacy
• 41.7% (10/24) overall response rate (ORR) per RECIST 1.1, including 4 complete responses
• 75% (18/24) disease control rate (DCR)
• 17.8 months median Overall Survival
• Exploratory analysis in a subset of patients (n=8) identified IL-1β, a cytokine linked to treatment-induced anti-tumor immunity, as the most increased plasma cytokine after treatment
• Investigators concluded that these preliminary findings warrant further evaluation in randomized clinical trials for patients with primary cutaneous melanoma naïve or refractory to anti-PD-1

Data presented at the 2026 Congress of the European Society for Medical Oncology

PARIS and CAMBRIDGE, Mass., Oct. 24, 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 results from patients with anti-PD-1-resistant advanced primary cutaneous melanoma treated in the ongoing Phase 1 Study 1100. The study evaluates JNJ-1900 (NBTXR3), which works in the presence of radiotherapy, followed by an immune checkpoint inhibitor (nivolumab or pembrolizumab) in patients with advanced solid tumors. The data were presented by Jason Chan, MD, Associate Professor, Department of Radiation Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, in a poster session on Saturday, October 24, 2026, at the 2026 Annual Meeting of the European Society for Medical Oncology (“ESMO”) in Madrid, Spain.

ABSTRACT #3956: 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

^{J. Chan, J. Lee, A. Lam, A. Daud, F. Collichio, H. Yu, P. Mody, J. Weiss, S. Moschos, S. Powell, S. Peck, M. Lohr, E. Redstone, Z. Li, W. Smith, A. Juloori, R. Gineste, D. Rolando, A. Rosenberg and C. Shen. UCSF Helen Diller Family Comprehensive Cancer Center; UNC Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill; Sanford Cancer Center; St Luke's University Hospital; The University of Chicago; Nanobiotix}

Patients with advanced anti-PD-1 resistant primary cutaneous melanoma whose disease has progressed after multiple prior lines of therapy have a poor prognosis; published series report a median progression-free survival of approximately three months¹ and a median overall survival of approximately one year² in this setting. Melanoma has historically been considered radioresistant, and higher radiation doses are often limited by exposure of the surrounding healthy tissue.

“Patients whose melanoma has progressed on anti-PD-1 therapy, and often on several other immunotherapies as well, have limited options left,” said Jason Chan, MD, Associate Professor, Department of Radiation Oncology, UCSF Helen Diller Family Comprehensive Cancer Center “In this study, a single injection followed by a short course of stereotactic radiotherapy was feasible across a wide range of tumor sizes and locations, and we saw responses in lesions that were injected and in lesions that were not. The observed increase in IL-1β suggests treatment-related immune activation that warrants further investigation. These are early data from a single-arm study, and they support testing the approach in a randomized trial.”

All 24 heavily pre-treated patients had advanced primary cutaneous melanoma resistant to anti-PD-1; 14 had stage IV disease. Most had received other immunotherapies before enrolling, including anti-CTLA-4 (50%), anti-LAG-3 (33.3%) and T-VEC (25%), and 87.5% had received immunotherapy as their most recent therapy. Patients received a one-time intratumoral injection of JNJ-1900 (NBTXR3) at the recommended Phase 2 dose (33% of gross tumor volume), followed by stereotactic body radiotherapy (“SBRT”) to the injected lesion and then nivolumab or pembrolizumab. Investigators observed an acceptable safety profile and early signals of efficacy.

Safety and Feasibility

Treatment consisting of a single intratumoral JNJ-1900 (NBTXR3) injection, followed by a short course of radiotherapy was feasible across a wide range of melanoma lesions, providing a minimally invasive treatment approach with an acceptable safety profile. No new safety signals have been observed.

Preliminary Efficacy

An Overall Response Rate (ORR) of 41.7% (10/24 patients) was observed. Responses were observed in both injected (ORR 45.8%; 11/24 evaluable patients) and non-injected lesions (ORR 30.0%; 3/10 evaluable patients).

Median Progression Free Survival (PFS) was 6.9 months, while median Overall Survival reached 17.8 months.

Exploratory Immune Profiling

In an exploratory analysis of plasma samples from a subset of patients (n=8), IL-1β showed the largest increase from baseline among the cytokines evaluated. Published research has linked IL-1β to treatment-induced anti-tumor immunity through its role in connecting innate immune activation to the priming of tumor-specific CD8+ T cells.³

"This updated analysis, with more patients and longer follow-up, builds on the first data we reported with consistent safety and an improvement in Overall Survival relative to the first data reported," said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. "Responses were again seen in patients whose disease had progressed after multiple prior therapies, including in lesions that were not injected. Together with the exploratory cytokine data, these findings warrant further evaluation of JNJ-1900 (NBTXR3) followed by anti-PD-1 therapy in patients with anti-PD-1-resistant melanoma."

Overall, the acceptable safety profile and early efficacy observed by investigators in these preliminary findings provide promising signals of activity and warrant further evaluation in larger randomized trials.

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 designed to work in the presenced of radiotherapy. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when in the presence of 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.

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 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 March 31, 2026 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2025 universal registration document filed with the AMF on March 31, 2026 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, 2026, 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 contact@nanobiotix.com	Investor Relations Department Joanne Choi VP, Investor Relations (US) joanne.choi@nanobiotix.com  Ricky Bhajun Director, Investor Relations (EU) 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

________________ 

_{¹Patrinely JR Jr., Cancer. 2020
²Nordstrom BL, Future Oncol. 18:1343-1355, 2022
³Ghiringhelli et al. Nat Med. 15(10):1170-8, 2009}

Attachment

• PR_Study 1100 Melanoma Data ESMO 2026

FAQ

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

What did Nanobiotix's Phase 1 JNJ-1900 melanoma study show?

The study reported an overall response rate of 41.7% (10/24), including four complete responses, in heavily pre-treated patients with anti-PD-1-resistant advanced primary cutaneous melanoma. Disease control reached 75% (18/24). Median progression-free survival was 6.9 months, and median overall survival was 17.8 months. The findings are preliminary and come from a single-arm study.

How was JNJ-1900 administered in Nanobiotix's melanoma study?

Patients received a one-time injection directly into the tumor at the recommended Phase 2 dose, equal to 33% of gross tumor volume. Stereotactic body radiotherapy, a targeted radiation treatment, was then delivered to the injected lesion, followed by nivolumab or pembrolizumab.

What prior treatments had patients received in Nanobiotix's JNJ-1900 melanoma study?

All 24 patients had advanced primary cutaneous melanoma resistant to anti-PD-1 therapy and had received multiple prior treatment lines. Previous immunotherapies included anti-CTLA-4 in 50%, anti-LAG-3 in 33.3% and T-VEC in 25%. Immunotherapy was the most recent treatment for 87.5% of patients.