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
Nanobiotix (NASDAQ: NBTX) has announced promising new results from a Phase 1 study of JNJ-1900 (NBTXR3) combined with immune checkpoint inhibitors for treating primary cutaneous melanoma resistant to anti-PD-1. The study showed a 47.4% objective response rate and 78.9% disease control rate in all lesions per RECIST 1.1.
Key findings include a median Overall Survival of 14.6 months and establishment of the recommended phase 2 dose at 33% of gross tumor volume. The treatment demonstrated a favorable safety profile, with only 5 patients experiencing treatment-related adverse events. Notably, in JNJ-1900 injected & irradiated tumors, researchers observed a 100% disease control rate.
Nanobiotix (NASDAQ: NBTX) ha annunciato nuovi risultati promettenti da uno studio di fase 1 su JNJ-1900 (NBTXR3) combinato con inibitori del checkpoint immunitario per trattare il melanoma cutaneo primario resistente all'anti-PD-1. Lo studio ha mostrato un tasso di risposta obiettiva del 47,4% e un tasso di controllo della malattia del 78,9% in tutte le lesioni secondo RECIST 1.1.
Tra i principali riscontri vi sono una sopravvivenza globale mediana di 14,6 mesi e l'istituzione della dose raccomandata per la fase 2 pari al 33% del volume tumorale lordo. Il trattamento ha dimostrato un profilo di sicurezza favorevole, con solo 5 pazienti che hanno registrato eventi avversi correlati al trattamento. È interessante notare che nei tumori iniettati e irradiati con JNJ-1900, i ricercatori hanno osservato un 100% di controllo della malattia.
Nanobiotix (NASDAQ: NBTX) ha anunciado nuevos resultados prometedores de un estudio de fase 1 de JNJ-1900 (NBTXR3) combinado con inhibidores del punto de control inmunitario para tratar el melanoma cutáneo primario resistente al anti-PD-1. El estudio mostró una tasa de respuesta objetiva del 47,4% y una tasa de control de la enfermedad del 78,9% en todas las lesiones según RECIST 1.1.
Entre los hallazgos clave se incluye una supervivencia global mediana de 14,6 meses y el establecimiento de la dosis recomendada de la fase 2 en el 33% del volumen tumoral bruto. El tratamiento mostró un perfil de seguridad favorable, con solo 5 pacientes experimentando eventos adversos relacionados con el tratamiento. Cabe destacar que, en los tumores inyectados y irradiados con JNJ-1900, los investigadores observaron un 100% de control de la enfermedad.
나노바이오틱스(NASDAQ: NBTX)는 면역 체크포인트 억제제와 결합된 JNJ-1900(NBTXR3)의 1상 연구에서 anti-PD-1에 내성을 가진 1차 피부 흑색종 치료에 대한 유망한 새로운 결과를 발표했습니다. 연구는 모든 병변에서 RECIST 1.1에 따른 객관적 반응률 47.4%와 질병 조절률 78.9%를 보여주었습니다.
주요 결과로 중위 Overall 생존 14.6개월과 총 종양 부피의 33%에서 2상 권장 용량이 확립되었습니다. 치료는 안전성 프로파일이 우수했으며, 치료 관련 부작용은 단 5명의 환자에서만 나타났습니다. 특히 JNJ-1900 주사 및 조사된 종양에서 질병 조절률 100%이 관찰되었습니다.
Nanobiotix (NASDAQ: NBTX) a annoncé des résultats prometteurs d'un essai de phase 1 de JNJ-1900 (NBTXR3) associé à des inhibiteurs du point de contrôle immunitaire pour traiter le mélanome cutané primaire résistant à l'anti-PD-1. L'étude a montré un taux de réponse objectif de 47,4% et un taux de contrôle de la maladie de 78,9% sur toutes les lésions selon RECIST 1.1.
Parmi les résultats clés figurent une survie globale médiane de 14,6 mois et l'établissement de la dose recommandée pour la phase 2 à 33% du volume tumoral brut. Le traitement a démontré un profil de sécurité favorable, avec seulement 5 patients présentant des événements indésirables liés au traitement. Fait notable, dans les tumeurs injectées et irradiées par JNJ-1900, les chercheurs ont observé un taux de contrôle de la maladie de 100%.
Nanobiotix (NASDAQ: NBTX) hat vielversprechende neue Ergebnisse aus einer Phase-1-Studie von JNJ-1900 (NBTXR3) berichtet, das mit Immun-Checkpoint-Inhibitoren zur Behandlung von primärem kutanem Melanom kombiniert wird, das gegen anti-PD-1 resistent ist. Die Studie zeigte eine Objektive-Response-Rate von 47,4% und eine krankheitskontrollrate von 78,9% bei allen Läsionen nach RECIST 1.1.
Zu den wichtigsten Erkenntnissen gehört eine median Überlebensdauer von 14,6 Monaten und die Festlegung der empfohlenen Dosis für Phase 2 bei 33% des Brutto-Tumorvolumens. Die Behandlung zeigte ein günstiges Sicherheitsprofil, wobei nur 5 Patienten behandlungsbedingte Nebenwirkungen erlebten. Bemerkenswert ist, dass bei JNJ-1900 injizierten und bestrahlten Tumoren ein 100%iges Krankheitskontrollrate beobachtet wurde.
نانوبيوتكس (نيسداك: NBTX) أعلنت عن نتائج واعدة جديدة من تجربة المرحلة 1 لـ JNJ-1900 (NBTXR3) المدمجة مع مثبطات نقاط التفتيش المناعية لعلاج الورم الميلانيني الجلدي الأولي المقاومة لـ anti-PD-1. أظهرت الدراسة معدل استجابة موضوعي قدره 47.4% و معدل السيطرة على المرض 78.9% في جميع الآفات وفقًا لـ RECIST 1.1.
تشمل النتائج الرئيسية البقاء على قيد الحياة العام الوسيط 14.6 شهرًا وتحديد جرعة المرحلة 2 الموصى بها عند 33% من حجم الورم الإجمالي. أظهر العلاج ملف أمان مفضل، حيث عانى فقط 5 مرضى من أحداث سلبية مرتبطة بالعلاج. والجدير بالذكر أنه في الأورام المحقونة والمشعّة بـ JNJ-1900، لاحظ الباحثون سيطرة على المرض بنسبة 100%.
Nanobiotix (NASDAQ: NBTX) 已宣布一项关于 JNJ-1900 (NBTXR3) 与免疫检查点抑制剂联合使用治疗抗 PD-1 的原发性皮肤黑色素瘤的 I 期研究取得的令人鼓舞的新结果。研究显示所有病灶按照 RECIST 1.1 的 客观缓解率 47.4% 和 疾病控制率 78.9%。
关键发现包括 中位总生存期 14.6 个月，并确定了第二阶段推荐剂量为肿瘤总体积的 33%。治疗显示出良好的安全性特征，只有 5 例患者出现与治疗相关的不良事件。值得注意的是，在 JNJ-1900 注射并照射的肿瘤中，研究人员观察到 疾病控制率 100%。
- None.
- Only Phase 1 results, requiring further investigation in randomized clinical trials
- 2 patients were not evaluable due to lack of post-treatment imaging
- One patient experienced grade 3+ treatment-emergent adverse events
Insights
NBTX's JNJ-1900 shows promising 47.4% response rate in melanoma patients resistant to standard immunotherapies, with favorable safety at established Phase 2 dose.
NANOBIOTIX has presented encouraging results from their ongoing Phase 1 study of JNJ-1900 (NBTXR3), their nanotherapeutic approach for treating cancer. The data focuses on primary cutaneous melanoma patients who had previously progressed after anti-PD-1 immunotherapy treatment - a particularly challenging patient population with limited options.
The treatment approach involves a one-time intratumoral injection of JNJ-1900, followed by radiotherapy and anti-PD-1 therapy. The study established 33% of gross tumor volume as the recommended Phase 2 dose, confirming injection feasibility at this level.
The efficacy data shows promising signals in this difficult-to-treat population:
47.4% objective response rate in all lesions (9 of 19 evaluable patients)- 4 complete responses and 5 partial responses
78.9% disease control rate (15 of 19 patients)100% disease control rate in directly injected and irradiated tumors- 14.6 months median overall survival across all treated patients
Importantly, researchers observed a relationship between local response depth and systemic tumor regression, suggesting potential immune system priming or reactivation. This supports the mechanistic hypothesis that local treatment with JNJ-1900 might trigger broader systemic anti-tumor effects.
Safety data appears favorable, with only 5 patients experiencing treatment-emergent adverse events related to JNJ-1900 or the injection procedure, and just 1 patient experiencing grade 3+ events (hypotension and pleuritic pain).
These results in a heavily pre-treated population who had exhausted standard therapies including anti-PD-1, ipilimumab, T-VEC, TIL, and radiotherapy represent a potentially significant advance. The investigators have concluded these findings warrant further investigation in randomized clinical trials.
- Data show a favorable safety profile and early efficacy signals in a heavily pre-treated population whose cancer progressed after multiple prior lines of therapy including anti-PD-1
- 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 1.178.9% (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)
- Investigators concluded that these data warrant further investigation in randomized clinical trials as a potential new option for patients with primary cutaneous melanoma naïve or refractory to anti-PD-1
- Nanobiotix will host a conference call to discuss the data on September 18, 2025 at 8:00AM EDT/ 2:00PM CEST
Data presented on September 17 at the 2025 Immunorad Conference
PARIS and CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced new results focused on patients with primary cutaneous melanoma from the ongoing Phase 1 Study 1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors (pembrolizumab or nivolumab) for patients with advanced cancers. These findings were presented at the 2025 ImmunoRad conference in Paris, France on September 17.
Patients with anti-PD-1 resistant primary cutaneous melanoma in the study had advanced disease that progressed despite multiple prior lines of therapy, including anti–PD-1, ipilimumab, T-VEC, TIL, and radiotherapy (“RT”), among others. All patients received a one-time intratumoral injection of JNJ-1900 (NBTXR3) followed by RT and sequential anti–PD-1 therapy. As of the August 21, 2025, data cutoff, 21 patients had been injected with JNJ-1900 and 19 were evaluable for tumor response (2 patients were not evaluable due to lack of post-treatment imaging).
"The patients in this analysis represent one of the more difficult clinical challenges we face as many have exhausted standard therapies, including checkpoint inhibitors," said Study 1100 Coordinating Investigator Colette Shen, MD, PhD, Assistant Professor of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center. "While these data are preliminary, the responses we’re seeing provide a strong signal that this treatment approach could potentially offer a new possibility for patients who need more options."
Safety and Feasibility
All 21 patients with primary cutaneous melanoma had shown prior resistance to anti-PD-1 and treatment with RT-activated JNJ-1900 (NBTXR3) followed by anti-PD-1 showed a favorable safety profile:
- Injection feasibility was confirmed at the recommended Phase 2 dose (
33% GTV) - In total, 16 patients experienced grade 1, grade 2, or grade 3+ TEAEs related to the overall therapeutic regimen (RT, anti-PD-1, JNJ-1900 (NBTXR3), and injection procedure)
- Of which 5 patients experienced grade 1, grade 2, or grade 3+ treatment-emergent adverse events (TEAEs) related to JNJ-1900 (NBTXR3) and/or the injection procedure
- Of these patients, 1 patient experienced grade 3+ TEAEs (hypotension and pleuritic pain)
Early Signs of Efficacy
JNJ-1900 (NBTXR3) demonstrated preliminary signals of efficacy in 19 patients who were evaluable for tumor response:
- A best observed objective response rate (“ORR”) in all lesions of
47.4% (9/19) per RECIST 1.1, including 4 complete responses and 5 partial responses - A best observed disease control rate (“DCR”) in all lesions of
78.9% (15/19) per RECIST 1.1 - In JNJ-1900 injected & irradiated tumors, a DCR of
100% (19/19) was observed - A median Overall Survival (mOS) of 14.6 months [
95% CI: 10.7 months; 16.7 months] in all patients treated (n=21)
Notably, a relationship was observed between the depth of local response and systemic tumor regression, suggesting a possible priming or re-activation of immune response.
"We are encouraged by these new findings and the potential signals of activity in this difficult-to-treat population," said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. "Notably, the relationship we observed between the depth of local response and systemic tumor regression further supports our hypothesis regarding the potentially broad applicability of JNJ-1900 (NBTXR3) for patients with cancer. We look forward to further clinical evaluation of JNJ-1900 (NBTXR3) to better understand its capacity to drive both local and systemic responses in primary cutaneous melanoma."
Nanobiotix Conference Call
Nanobiotix will host a conference call and webcast featuring Nanobiotix chief executive officer, Laurent Levy, to discuss the new data on Thursday, September 18th, 2025, at 8:00 AM EDT / 2:00 PM CET.
Details for the call are as follows:
Webcast link: https://edge.media-server.com/mmc/p/afhekjqh
Audio-only dial-in link: https://register-conf.media-server.com/register/BIcf7d5819d70446639d58b5a5867cf216
Participants can use the audio-only link above to register and obtain dial-in instructions to listen to the presentation via phone and ask questions during the Q&A session, or participants can use the webcast link to register and listen and watch the slide presentation online; the replay version will be available under the same webcast link shortly after the presentation and will be archived on the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior to the event start. Participants are invited to email their questions in advance to investors@nanobiotix.com.
About JNJ-1900 (NBTXR3)
JNJ-1900 (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 through a successful randomized Phase 2/3 study in 2018. 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. Given the physical MoA, Nanobiotix believes that JNJ-1900 (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 JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by 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 JNJ-1900 (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 JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.
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 25 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 02, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 02, 2025, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. 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.
Contacts
| 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 investors@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 Communications Becky Lauer +1 (646) 286-0057 nanobiotixteam@uncappedcommunications.com |
Attachment
- 2025-09-17 -- NBTX -- +New Ph1 NBTXR3 Data in Combo w-ICI -- FINAL
FAQ
What are the key results of NBTX's Phase 1 study for melanoma treatment?
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When will Nanobiotix discuss the melanoma trial results?
