NANOBIOTIX Announces First Data From Phase 1 Study Evaluating JNJ-1900 (NBTXR3) for Patients With Esophageal Cancer
Nanobiotix (NASDAQ: NBTX) has announced promising first data from a Phase 1 study of JNJ-1900 (NBTXR3) in patients with locally advanced esophageal adenocarcinoma. The study, conducted at MD Anderson Cancer Center, demonstrated an 85% disease control rate and 69% objective response rate among 13 patients.
The treatment, combining JNJ-1900 with chemoradiation, showed strong safety profile and confirmed injection feasibility. Key outcomes include 6 complete responses and 3 partial responses. Of 6 patients who underwent surgery, 2 achieved pathological complete response and 4 showed major pathologic response. The recommended Phase 2 dose was established at 33% of gross tumor volume.
The study continues with recruitment of 17 additional patients, exploring both photon and proton chemoradiation combinations.
Nanobiotix (NASDAQ: NBTX) ha annunciato primi dati incoraggianti da uno studio di fase 1 su JNJ-1900 (NBTXR3) in pazienti con adenocarcinoma esofageo localmente avanzato. Lo studio, condotto al MD Anderson Cancer Center, ha mostrato un 84-85% tasso di controllo della malattia e un 69% di risposta obiettiva su 13 pazienti.
Il trattamento, che combina JNJ-1900 con chemioradioterapia, ha evidenziato un profilo di sicurezza solido e la conferma della fattibilità di iniezione. Risultati chiave includono 6 risposte complete e 3 risposte parziali. Di 6 pazienti operati, 2 hanno ottenuto una risposta patologica completa e 4 hanno mostrato una grande risposta patologica. La dose raccomandata per la fase 2 è stata fissata al 33% del volume lordo della massa tumorale.
Lo studio procede con l'arruolamento di altri 17 pazienti, esaminando combinazioni di chemioradioterapia con fotoni e con protoni.
Nanobiotix (NASDAQ: NBTX) ha anunciado resultados iniciales prometedores de un estudio de fase 1 de JNJ-1900 (NBTXR3) en pacientes con adenocarcinoma esofágico localmente avanzado. El estudio, realizado en el MD Anderson Cancer Center, mostró un 85% de control de la enfermedad y un 69% de respuesta objetiva entre 13 pacientes.
El tratamiento, que combina JNJ-1900 con quimiorradioterapia, presentó un perfil de seguridad sólido y se confirmó la viabilidad de la inyección. Los resultados clave incluyen 6 respuestas completas y 3 respuestas parciales. De 6 pacientes que fueron operados, 2 alcanzaron respuesta patológica completa y 4 mostraron respuesta patológica significativa. La dosis recomendada para la fase 2 se estableció en un 33% del volumen tumoral bruto.
El estudio continúa con la reclutación de 17 pacientes adicionales, explorando combinaciones de quimiorradioterapia con fotones y con protones.
Nanobiotix (NASDAQ: NBTX)가 JNJ-1900(NBTXR3)의 제1상 연구에서 국소진행성 식도선암 환자를 대상으로 한 예비 데이터를 발표했습니다. MD 앤더슨 암센터에서 수행된 이 연구는 질환 조절률 85%와 객관적 반응률 69%를 13명 환자에서 보여주었습니다.
JNJ-1900과 화학방사선요법을 결합한 이 치료는 안전성 프로파일이 양호하고 주사 가능성도 확인되었습니다. 주요 결과로 완전 반응 6건과 부분 반응 3건이 포함됩니다. 수술을 받은 6명 중 2명은 병리학적 완전 반응을 보였고 4명은 주요 병리학적 반응을 보였습니다. 2상 권장 용량은 총 종양 부피의 33%로 확정되었습니다.
연구는 광자 및 양성자 화학방사선요법 조합을 모두 탐구하며 추가로 17명의 환자를 더 모집하는 것으로 계속 진행 중입니다.
Nanobiotix (NASDAQ: NBTX) a annoncé des premiers résultats encourageants d’une étude de phase 1 sur JNJ-1900 (NBTXR3) chez des patients atteints d’un adénocarcinome œsophagien localement avancé. L’étude, réalisée au MD Anderson Cancer Center, affiche un taux de contrôle de la maladie de 85% et un taux de réponse objective de 69% sur 13 patients.
Le traitement, associant JNJ-1900 à une chemioradiothérapie, a démontré un profil de sécurité robuste et la faisabilité de l’injection. Parmi les résultats clés figurent 6 rémissions complètes et 3 rémissions partielles. Sur les 6 patients opérés, 2 ont obtenu une réponse pathologique complète et 4 une réponse pathologique majeure. La dose recommandée pour la phase 2 est fixée à 33% du volume tumoral brut.
L’étude se poursuit avec le recrutement de 17 patients supplémentaires, explorant des combinaisons de chimioradiothérapie avec des photons et des protons.
Nanobiotix (NASDAQ: NBTX) hat vielversprechende Anfangsdaten einer Phase-1-Studie zu JNJ-1900 (NBTXR3) bei Patienten mit lokal fortgeschrittenem ösophagalen Adenokarzinom angekündigt. Die Studie im MD Anderson Cancer Center zeigte eine 85%ige Krankheitskontrolle und eine 69%ige objektive Ansprechrate bei 13 Patienten.
Die Behandlung, die JNJ-1900 mit Chemoradiation kombiniert, wies ein starkes Sicherheitsprofil auf und bestätigte die Durchführbarkeit der Injektion. Wichtige Ergebnisse umfassen 6 komplette Remissionen und 3 partielle Remissionen. Von 6 operierten Patienten erzielten 2 eine pathologische vollständige Remission und 4 zeigten eine ausgeprägte pathologische Reaktion. Die empfohlene Dosis für Phase-2 wurde auf 33% des Brutto-Tumorvolumens festgelegt.
Die Studie läuft weiter mit der Rekrutierung von 17 weiteren Patienten und untersucht sowohl Photonen- als auch Protonen-Chemoradiation-Kombinationen.
نانوبيوتيكس (NASDAQ: NBTX) أطلقت بيانات أولية واعدة من تجربة من المرحلة 1 لـ JNJ-1900 (NBTXR3) لدى مرضى سرطان المريء الغير قابل للشفاء محلياً. الدراسة التي أُجريت في مركز إم دي أندرسون للسرطان أظهرت معدل سيطرة على المرض بلغ 85% و معدل استجابة موضوعية بلغ 69% من بين 13 مريضاً.
العلاج، الذي يجمع JNJ-1900 مع العلاج الكيميائي الإشعاعي، أظهر ملفاً سلامياً قوياً وأكد إمكانية الحقن. تشمل النتائج الرئيسية 6 استجابات كاملة و 3 استجابات جزئية. من بين 6 مرضى خضعوا لجراحة، حقق 2 منهم استجابة مرضية كاملة وظهر لدى 4 آخرين استجابة مرضية كبيرة. تم تثبيت الجرعة الموصى بها للمرحلة 2 عند 33% من حجم الورم الإجمالي.
تستمر الدراسة مع تسجيل 17 مريضاً إضافياً، مستكشفة توليفات الكيمياء الإشعاعية مع كل من الفوتونات والبروتونات.
Nanobiotix (NASDAQ: NBTX) 已宣布一项面向局部进展期食道腺癌患者的 JNJ-1900（NBTXR3）1期研究的初步数据。研究在MD Anderson癌症中心进行，显示在13名患者中实现了 85% 的疾病控制率 和 69% 的客观缓解率。
该治疗将 JNJ-1900 与化放疗相结合，安全性良好且注射可行性得到确认。关键结果包括 6 例完全缓解 和 3 例部分缓解。在接受手术的6名患者中，2名达到病理学完全缓解，4名显示出主要病理反应。推荐的II期剂量设定为肿瘤总体积的 33%。
研究将继续招募另外17名患者，探索光子与质子化疗放疗的组合。
- High efficacy with 85% disease control rate and 69% objective response rate
- Strong complete response rate with 6 biopsy-confirmed complete responses
- Excellent surgical outcomes: 2 pathological complete responses and 4 major pathologic responses out of 6 surgeries
- Well-tolerated safety profile with no periprocedural or delayed adverse events
- Successfully established recommended Phase 2 dose
- 2 patients experienced grade 3+ treatment-emergent adverse events related to JNJ-1900
- Small initial patient population (n=13) limits broader conclusions
Insights
Nanobiotix reports promising early results for JNJ-1900 in esophageal cancer with high response rates and good tolerability.
The Phase 1 data from MD Anderson for JNJ-1900 (NBTXR3) in esophageal adenocarcinoma shows considerable promise. The treatment demonstrated an impressive
The safety profile appears manageable - while all 13 patients experienced treatment-emergent adverse events, only 6 had events related to JNJ-1900 itself, with just 2 patients experiencing grade 3+ events attributed to the drug. The intratumoral injection procedure was well-tolerated with no grade 3+ procedure-related adverse events.
For context, esophageal cancer represents a significant therapeutic challenge with high mortality rates (508,600 deaths annually from 572,000 cases). Current standard treatment involving chemoradiotherapy followed by surgical esophagectomy carries substantial toxicity and negative quality-of-life impacts. JNJ-1900's mechanism of action as a radioenhancer could potentially improve local tumor control without adding significant toxicity.
The established recommended Phase 2 dose of
While these results are preliminary from a small sample (n=13), the
- 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
PARIS and CAMBRIDGE, Mass., Oct. 01, 2025 (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 first data from cohorts 1 and 2 of the dose escalation part of a Phase 1 dose escalation and dose expansion study evaluating JNJ-1900 (NBTXR3) combined with photon chemoradiation (cohort 1) or proton chemoradiation (cohort 2) followed by surgery, if medically indicated, for patients with locally advanced adenocarcinoma of the esophagus (“EADC”). The study is sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and results were presented by Principal Investigator Steven Lin, MD, PhD, Professor of Radiation Oncology at MD Anderson at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO).
ABSTRACT # 1113: ENDOSCOPIC ULTRASOUND FINE NEEDLE INJECTION OF NBTXR3 ACTIVATED BY RADIOTHERAPY WITH CONCURRENT CHEMOTHERAPY FOR ADENOCARCINOMA OF THE ESOPHAGUS: FEASIBILITY AND SAFETY OF THE PHASE 1 DOSE ESCALATION PART FOR THE PHOTON-BASED COHORT
Steven H. Lin, Emmanuel Coronel, Saumil Gandhi, Julianna Bronk, David Qian, Joe Y. Chang, Michael O’Reilly, Matthew Ning, Aileen Chen, Quynh Nguyen, James Welsh, Diana Amaya, Christina Hoang, Wayne Hofstetter, Mariela Blum-Murphy, Albert C. Koong, Zhongxing Liao
MD Anderson Cancer Center, Houston, Texas, USA
Esophageal cancer is the eighth most common cancer worldwide with an estimated 572,000 new cases and 508,600 deaths each year. Radiotherapy is a cornerstone of treatment and neoadjuvant chemoradiotherapy (“CRT”) followed by surgery is the standard of care. However, there is some controversy as to whether the toxicities of neoadjuvant CRT will lead to increased postoperative complications. Moreover, surgical removal of large segments of the esophagus (esophagectomy) is associated with significant comorbidities and negative impact on patients’ quality of life. Treatment strategies that enhance local control, reduce the need for surgery, and improve survival outcomes are an important unmet need.
“Esophageal cancer remains one of the most difficult contexts for both patients and clinicians, where existing standards of care can create significant burdens for patients,” said Louis Kayitalire, Chief Medical Officer at Nanobiotix. “We believe that JNJ-1900 (NBTXR3), through its broadly applicable mechanism of action, could offer a novel approach—one designed to enhance local control and potentially reduce the need for highly invasive procedures such as esophagectomy.”
Safety and Feasibility
Treatment was well-tolerated and feasible in the study population (n=13):
- Feasibility of endoscopic ultrasound-guided intratumoral injection was confirmed in 9 EADC patients with treated JNJ-1900 (NBTXR3) combined with photon CRT in cohort 1 and 4 EADC patients treated with JNJ-1900 (NBTXR3) combined with proton CRT in cohort 2
- The recommended Phase 2 dose (“RP2D”) for JNJ-1900 (NBTXR3) combined with photon CRT was established at
33% of gross tumor volume (GTV) - In total, 13 patients experienced treatment-emergent adverse events (“TEAEs”) of any grade related to the overall treatment (Chemotherapy, RT, JNJ-1900 (NBTXR3), and injection procedure)
- Of which, 6 patients experienced TEAEs of any grade (1, 2, or 3+) related to JNJ-1900 (NBTXR3) and 2 patient experienced TEAEs of any grade related to the injection procedure
- Of these patients, 2 experienced grade 3+ TEAEs related to JNJ-1900 (NBTXR3) and 0 experienced grade 3+ TEAEs related to the injection procedure
- Of which, 6 patients experienced TEAEs of any grade (1, 2, or 3+) related to JNJ-1900 (NBTXR3) and 2 patient experienced TEAEs of any grade related to the injection procedure
- No periprocedural or delayed adverse events were observed
Signals of Efficacy
Promising initial clinical response and outcomes:
85% (11/13) disease control rate (DCR)69% (9/13) objective response rate (ORR), including 6 biopsy-confirmed complete responses (CRs) and 3 partial responses (PRs)- 6 patients in the study were medically indicated for and underwent surgery after treatment with CRT and JNJ-1900 (NBTXR3)
- 2 of these patients had pathological complete response (pCR)
- 4 of these patients had major pathologic response (≤
10% viable cells)
“These early results support our hypothesis that intratumoral injection of JNJ-1900 (NBTXR3) in combination with chemoradiation is both technically feasible and generally well-tolerated in patients with locally advanced esophageal adenocarcinoma,” said Steven Lin, MD, PhD, Professor of Radiation Oncology at MD Anderson. “Importantly, we observed encouraging rates of disease control and complete response that suggest this novel approach could help improve local tumor control while potentially sparing patients from the risks and long-term consequences of esophagectomy. These early findings provide a strong foundation for further investigation.”
Importantly, this evaluation in locally advanced esophageal cancer could potentially open a new indication for JNJ-1900 (NBTXR3) and provide support for the investigational radioenhancer in combination with proton radiation therapy as an additional activation modality beyond standard (photon) radiation therapy. Recruitment for dose escalation cohort 1 is complete. 5 additional patients are being recruited for dose escalation cohort 2, which will be followed by recruitment of 12 additional patients for the dose expansion part of the study.
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 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.
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
- 2025-10-01 -- NBTX -- Ph1 NBTXR3 Data in EADC -- FINAL
FAQ
What are the key results from Nanobiotix's (NBTX) Phase 1 esophageal cancer trial?
What is the recommended Phase 2 dose for NBTX's JNJ-1900 in esophageal cancer?
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What were the safety results for Nanobiotix's JNJ-1900 in esophageal cancer?
How many additional patients will be recruited in the NBTX esophageal cancer study?
