Nanobiotix Announces First Data From the Completed Dose Escalation Part of a Phase 1 Study Evaluating NBTXR3 (JNJ-1900) as a 2L+ Therapy for Patients With Locally Advanced NSCLC
Nanobiotix (NBTX) has released initial data from a completed Phase 1 dose escalation study evaluating NBTXR3 (JNJ-1900) as a second-line or later therapy for locally advanced non-small cell lung cancer (NSCLC) patients eligible for re-irradiation.
The study, conducted at MD Anderson Cancer Center, demonstrated favorable safety outcomes with no dose-limiting toxicities or Grade 3+ serious adverse events related to NBTXR3. The recommended phase 2 dose was established at 33% of gross tumor volume.
Preliminary survival data from 12 patients showed promising results with:
- 12-month local progression-free survival (LPFS) of 64% (median 18.6 months)
- 12-month overall survival (OS) of 83% (median 30.2 months)
The expansion phase is currently ongoing with 5 out of 12 patients injected to date.
Nanobiotix (NBTX) ha rilasciato dati iniziali da uno studio di fase 1 completato che valuta NBTXR3 (JNJ-1900) come terapia di seconda linea o successiva per pazienti con cancro polmonare non a piccole cellule (NSCLC) localmente avanzato idonei per una nuova irradiamento.
Lo studio, condotto presso il MD Anderson Cancer Center, ha dimostrato risultati di sicurezza favorevoli senza tossicità limitanti la dose o eventi avversi gravi di Grado 3+ correlati a NBTXR3. La dose raccomandata per la fase 2 è stata stabilita al 33% del volume tumorale lordo.
I dati preliminari sulla sopravvivenza di 12 pazienti hanno mostrato risultati promettenti con:
- una sopravvivenza libera da progressione locale (LPFS) a 12 mesi del 64% (mediana 18,6 mesi)
- una sopravvivenza globale (OS) a 12 mesi dell'83% (mediana 30,2 mesi)
La fase di espansione è attualmente in corso con 5 dei 12 pazienti iniettati fino ad oggi.
Nanobiotix (NBTX) ha publicado datos iniciales de un estudio de escalado de dosis de fase 1 completado que evalúa NBTXR3 (JNJ-1900) como terapia de segunda línea o posterior para pacientes con cáncer de pulmón no microcítico (NSCLC) localmente avanzado elegibles para reirradiación.
El estudio, realizado en el MD Anderson Cancer Center, demostró resultados de seguridad favorables sin toxicidades limitantes de dosis ni eventos adversos graves de Grado 3+ relacionados con NBTXR3. La dosis recomendada para la fase 2 se estableció en el 33% del volumen tumoral bruto.
Los datos preliminares de supervivencia de 12 pacientes mostraron resultados prometedores con:
- una supervivencia libre de progresión local (LPFS) a 12 meses del 64% (mediana 18,6 meses)
- una supervivencia global (OS) a 12 meses del 83% (mediana 30,2 meses)
La fase de expansión está actualmente en curso, con 5 de los 12 pacientes inyectados hasta la fecha.
Nanobiotix (NBTX)는 국소 진행성 비소세포 폐암(NSCLC) 환자를 위한 2차 또는 이후 치료제로 NBTXR3 (JNJ-1900)을 평가하는 완료된 1상 용량 증량 연구의 초기 데이터를 발표했습니다.
MD 앤더슨 암 센터에서 실시된 이 연구는 NBTXR3와 관련된 용량 제한 독성이나 3등급 이상의 심각한 부작용 없이 유리한 안전성 결과를 보여주었습니다. 2상 연구를 위한 권장 용량은 총 종양 용적의 33%로 설정되었습니다.
12명의 환자로부터의 초기 생존 데이터는 다음과 같은 유망한 결과를 보여주었습니다:
- 12개월 국소 진행 없는 생존율(LPFS) 64% (중앙값 18.6개월)
- 12개월 전체 생존율(OS) 83% (중앙값 30.2개월)
확장 단계는 현재 진행 중이며, 지금까지 12명 중 5명이 주사를 받았습니다.
Nanobiotix (NBTX) a publié des données initiales d'une étude d'escalade de dose de phase 1 achevée évaluant NBTXR3 (JNJ-1900) comme thérapie de deuxième ligne ou ultérieure pour les patients atteints de cancer du poumon non à petites cellules (NSCLC) localement avancé éligibles à une réirradiation.
L'étude, réalisée au MD Anderson Cancer Center, a montré des résultats de sécurité favorables sans toxicités limitantes de dose ni événements indésirables graves de Grade 3+ liés à NBTXR3. La dose recommandée pour la phase 2 a été établie à 33 % du volume tumoral brut.
Les données préliminaires de survie de 12 patients ont montré des résultats prometteurs avec:
- un taux de survie sans progression locale (LPFS) à 12 mois de 64 % (médiane 18,6 mois)
- un taux de survie global (OS) à 12 mois de 83 % (médiane 30,2 mois)
La phase d'expansion est actuellement en cours, avec 5 des 12 patients injectés à ce jour.
Nanobiotix (NBTX) hat erste Daten aus einer abgeschlossenen Phase-1-Dosissteigerungsstudie veröffentlicht, die NBTXR3 (JNJ-1900) als Zweitlinien- oder spätere Therapie für Patienten mit lokal fortgeschrittenem nicht-kleinzelligem Lungenkrebs (NSCLC), die für eine Reirradiation geeignet sind, bewertet.
Die Studie, die am MD Anderson Cancer Center durchgeführt wurde, zeigte günstige Sicherheitsresultate ohne dosislimitierende Toxizitäten oder schwere unerwünschte Ereignisse der Grad 3+ in Verbindung mit NBTXR3. Die empfohlene Dosis für die Phase 2 wurde auf 33 % des Bruttotumorvolumens festgelegt.
Vorläufige Überlebensdaten von 12 Patienten zeigten vielversprechende Ergebnisse mit:
- einer 12-monatigen progressionsfreien Überlebensrate (LPFS) von 64 % (Median 18,6 Monate)
- einer 12-monatigen Gesamtüberlebensrate (OS) von 83 % (Median 30,2 Monate)
Die Erweiterungsphase läuft derzeit, wobei bis heute 5 von 12 Patienten injiziert wurden.
- Favorable safety profile with no dose-limiting toxicities
- Promising survival data: 83% 12-month overall survival
- Strong efficacy signals with 64% 12-month local progression-free survival
- Successfully established recommended Phase 2 dose
- Only 5 of 12 patients enrolled so far in expansion phase
- patient sample size of 12 patients in dose escalation
Insights
The Phase 1 data for NBTXR3 (JNJ-1900) in locally advanced NSCLC represents a meaningful advance for a challenging patient population. For context, patients with recurrent NSCLC after prior radiation typically face severely options, with re-irradiation often restricted to palliative doses due to cumulative toxicity concerns.
The safety profile is particularly noteworthy - zero dose-limiting toxicities and no Grade 3+ serious adverse events in a re-irradiation setting demonstrates NBTXR3's potential to improve the therapeutic window. Establishing the recommended Phase 2 dose (33% of gross tumor volume) is a critical milestone that enables progression to efficacy-focused studies.
The preliminary survival metrics -
The mechanism of NBTXR3 as a radiation enhancer that's physically injected into tumors represents a novel approach to overcome radiation resistance. The advancement to the expansion phase with 5/12 patients already enrolled signals investigator confidence in the approach, though larger studies will be needed to definitively establish efficacy.
This early clinical data for NBTXR3 represents a positive development for Nanobiotix's pipeline advancement. The company has successfully completed the dose escalation phase with favorable safety results and has established a recommended Phase 2 dose - two essential de-risking milestones that enable continued development in this indication.
Beyond safety, the preliminary efficacy signals in this difficult-to-treat population provide early validation of NBTXR3's potential clinical utility. For context, this patient group (locally advanced NSCLC with prior radiation failure) represents a substantial commercial opportunity with high unmet need among the
The dual naming convention (NBTXR3/JNJ-1900) reflects Johnson & Johnson's involvement, following their
While these early data are promising, investors should note this represents just one piece of NBTXR3's broader development program. The agent's radioenhancer approach provides potential advantages in multiple cancer types where radiation is a standard component of care. The progression to expansion phase suggests confidence from clinical investigators, which may increase the probability of continued development success.
- Data show favorable safety and confirm injection feasibility in 12 patients with locally advanced NSCLC amenable to re-irradiation for whom prior lines of therapy have failed
- A preliminary review of survival data showed 12-month LPFS of
64% (median 18.6 months) and 12-month OS of83% (median 30.2 months) - The dose escalation part is complete, and 5/12 patients have been injected to date in the ongoing expansion part
PARIS and CAMBRIDGE, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering disruptive, nanotherapeutic approaches to revolutionize treatment outcomes for millions of patients, today announced the first data from the completed dose escalation part of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson") evaluating radiotherapy-activated NBTXR3 (JNJ-1900)1 as a second or later line (2L+) therapy for patients with locally advanced non-small cell lung cancer (“NSCLC”) amenable to re-irradiation. These data will be presented at the 2025 European Lung Cancer Conference by study principal investigator Dr. Saumil Gandhi.
ABSTRACT #207P: Phase 1 Study of Reirradiation (“ReRT”) with NBTXR3 (JNJ-1900) for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer (“NSCLC”)
Saumil J. Gandhi, MD, PhD, Enoch Chang, MD, Aileen Chen, MD, Stephen G. Chun, MD, Steven H. Lin, MD, PhD, Rachel C. Maguire, BS, Matthew S. Ning, MD, MPH, Julianna K. Bronk, MD, PhD, David Qian, MD, Joe Y. Chang, MD, PhD, James W. Welsh, MD, Zhongxing Liao, MD, Rahul A. Sheth, MD, Roberto F. Casal, MD
Locoregional recurrence occurs in 30
“Patients with recurrence after prior radiation therapy for locally advanced lung cancer face limited therapeutic options and significant challenges in achieving durable disease control,” said Saumil Gandhi, MD, PhD, Department of Thoracic Radiation Oncology, Division of Radiation Oncology at MD Anderson. “These data underscore the need for continued therapeutic innovation for these patients and highlight the potential of NBTXR3 (JNJ-1900) as a novel approach to improving patient outcomes.”
Results from the completed dose escalation part of the study demonstrated a favorable safety profile with no dose-limiting toxicities (DLTs), and no Grade 3 or higher SAEs related to NBTXR3. Injection feasibility was confirmed, and the recommended phase 2 dose (RP2D) was established at
Promising early efficacy signals were observed. Preliminary review of survival data from 12 patients showed 12-month LPFS of
“The Nanobiotix team is encouraged by these early findings, which suggest NBTXR3 (JNJ-1900) could offer a new therapeutic option for patients with no alternatives after prior treatments have failed,” said Louis Kayitalire, MD, Nanobiotix Chief Medical Officer. “Notably, these results were observed in patients who resisted prior curative radiation doses and that were treated with JNJ-1900 (NBTXR3) activated by a lower radiation dose. As we advance the study’s expansion phase, we look forward to further evaluating NBTXR3 (JNJ-1900)’s potential to improve patient outcomes.”
The expansion phase of the study is ongoing, with 5/12 patients injected to date.
About JNJ-1900 (NBTXR3)
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 for which the product received a European CE mark in 2019. The product candidate’s physical 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 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 NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in 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 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 NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of 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 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024, in Nanobiotix’ 2024 semi-annual report under the caption “Supplemental Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18, 2024, 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 Craig West SVP, Investor Relations +1 (617) 583-0211 investors@nanobiotix.com | |
| Media Relations | ||
France – HARDY Caroline Hardy +33 06 70 33 49 50 carolinehardy@outlook.fr | Global – uncapped Communications nanobiotixteam@uncappedcommunications.com | |
1 Potential first-in-class radioenhancer “NBTXR3” was licensed to Johnson & Johnson by Nanobiotix in 2023 and renamed “JNJ-1900” for the purposes of Johnson & Johnson-led clinical development.
Attachment
FAQ
What are the key survival results from NBTX's Phase 1 NSCLC study of NBTXR3?
What safety profile did NBTXR3 demonstrate in the NBTX Phase 1 NSCLC trial?
What is the recommended Phase 2 dose for NBTXR3 in NBTX's NSCLC study?
How many patients have been treated in the expansion phase of NBTX's NBTXR3 NSCLC study?
What patient population is being targeted in NBTX's NBTXR3 Phase 1 study?
