Nanobiotix Announces Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer
Nanobiotix (NBTX) announced full results from a completed Phase 1 study of JNJ-1900 (NBTXR3) in pancreatic cancer patients. The study, conducted at MD Anderson Cancer Center, showed promising outcomes in patients with locally advanced or borderline resectable pancreatic cancer (n=22). Key findings include:
- Median Overall Survival of 23 months from diagnosis [compared to 19.2 months historical data] - Median Local Progression-Free Survival of 13.3 months from radiation completion - CA19-9 normalization in 59% of patients (vs 17% historical data) - Two LAPC patients achieved R0 surgical resection - Favorable safety profile and injection feasibility
The study has expanded with a new cohort combining JNJ-1900 with standard-of-care concurrent chemoradiation after induction chemotherapy, with the first patient already injected.
Nanobiotix (NBTX) ha annunciato i risultati completi di uno studio di Fase 1 concluso su JNJ-1900 (NBTXR3) in pazienti con tumore pancreatico. Lo studio, condotto presso il MD Anderson Cancer Center, ha mostrato risultati promettenti in pazienti con carcinoma pancreatico localmente avanzato o borderline resecabile (n=22). I risultati principali includono:
- Sopravvivenza globale mediana di 23 mesi dalla diagnosi [rispetto ai 19,2 mesi dei dati storici]
- Sopravvivenza libera da progressione locale mediana di 13,3 mesi dalla fine della radioterapia
- Normalizzazione del CA19-9 nel 59% dei pazienti (contro il 17% dei dati storici)
- Due pazienti con LAPC hanno ottenuto una resezione chirurgica R0
- Profilo di sicurezza favorevole e fattibilità dell'iniezione
Lo studio è stato ampliato con una nuova coorte che combina JNJ-1900 con chemioradioterapia standard concomitante dopo chemioterapia di induzione, con il primo paziente già trattato.
Nanobiotix (NBTX) anunció los resultados completos de un estudio de Fase 1 finalizado sobre JNJ-1900 (NBTXR3) en pacientes con cáncer de páncreas. El estudio, realizado en el MD Anderson Cancer Center, mostró resultados prometedores en pacientes con cáncer pancreático localmente avanzado o borderline resecable (n=22). Los hallazgos clave incluyen:
- Supervivencia global media de 23 meses desde el diagnóstico [en comparación con 19,2 meses de datos históricos]
- Supervivencia libre de progresión local media de 13,3 meses desde la finalización de la radiación
- Normalización de CA19-9 en el 59% de los pacientes (vs 17% de datos históricos)
- Dos pacientes con LAPC lograron resección quirúrgica R0
- Perfil de seguridad favorable y factibilidad de la inyección
El estudio se ha ampliado con una nueva cohorte que combina JNJ-1900 con quimiorradiación estándar concurrente después de la quimioterapia de inducción, con el primer paciente ya inyectado.
Nanobiotix (NBTX)는 췌장암 환자를 대상으로 한 JNJ-1900 (NBTXR3)의 완료된 1상 연구의 전체 결과를 발표했습니다. MD Anderson 암센터에서 진행된 이 연구는 국소 진행성 또는 경계 절제 가능 췌장암 환자(n=22)에서 유망한 결과를 보였습니다. 주요 결과는 다음과 같습니다:
- 진단 후 중앙 전체 생존 기간 23개월 [과거 데이터 19.2개월 대비]
- 방사선 치료 완료 후 중앙 국소 무진행 생존 기간 13.3개월
- 환자의 59%에서 CA19-9 정상화 (과거 데이터 17% 대비)
- 두 명의 LAPC 환자가 R0 수술 절제 성공
- 우호적인 안전성 프로필 및 주사 가능성 확인
이 연구는 유도 화학요법 후 표준 동시 화학방사선요법과 JNJ-1900을 병용하는 새로운 코호트로 확장되었으며, 첫 환자가 이미 주사받았습니다.
Nanobiotix (NBTX) a annoncé les résultats complets d'une étude de Phase 1 terminée sur JNJ-1900 (NBTXR3) chez des patients atteints de cancer du pancréas. L'étude, réalisée au MD Anderson Cancer Center, a montré des résultats prometteurs chez des patients atteints d'un cancer du pancréas localement avancé ou borderline résécable (n=22). Les principales conclusions sont :
- Survie globale médiane de 23 mois à partir du diagnostic [contre 19,2 mois dans les données historiques]
- Survie sans progression locale médiane de 13,3 mois à partir de la fin de la radiothérapie
- Normalisation du CA19-9 chez 59 % des patients (contre 17 % dans les données historiques)
- Deux patients LAPC ont obtenu une résection chirurgicale R0
- Profil de sécurité favorable et faisabilité de l'injection
L'étude a été élargie avec une nouvelle cohorte combinant JNJ-1900 avec une chimioradiothérapie standard concomitante après une chimiothérapie d'induction, le premier patient ayant déjà été injecté.
Nanobiotix (NBTX) gab die vollständigen Ergebnisse einer abgeschlossenen Phase-1-Studie zu JNJ-1900 (NBTXR3) bei Patienten mit Bauchspeicheldrüsenkrebs bekannt. Die Studie, die am MD Anderson Cancer Center durchgeführt wurde, zeigte vielversprechende Ergebnisse bei Patienten mit lokal fortgeschrittenem oder grenzwertig resezierbarem Bauchspeicheldrüsenkrebs (n=22). Wichtige Erkenntnisse umfassen:
- Medianes Gesamtüberleben von 23 Monaten ab Diagnosestellung [im Vergleich zu 19,2 Monaten historischer Daten]
- Medianes lokal progressionsfreies Überleben von 13,3 Monaten ab Abschluss der Strahlentherapie
- CA19-9-Normalisierung bei 59% der Patienten (vs. 17% historische Daten)
- Zwei LAPC-Patienten erreichten eine R0-chirurgische Resektion
- Günstiges Sicherheitsprofil und Machbarkeit der Injektion
Die Studie wurde mit einer neuen Kohorte erweitert, die JNJ-1900 mit der Standard-Chemoradiotherapie nach Induktionschemotherapie kombiniert, wobei der erste Patient bereits injiziert wurde.
- Median Overall Survival of 23 months exceeded historical data of 19.2 months
- High rate of CA19-9 normalization at 59% compared to historical 17%
- Favorable safety profile demonstrated in Phase 1 study
- Two LAPC patients achieved surgical resection, indicating potential for improved outcomes
- Study expansion approved with first patient already enrolled in new cohort
- Only 22 patients in the study, limiting statistical significance
- Majority of patients (20/22) still had unresectable disease
- Results are from early-stage Phase 1 trial, requiring further validation in larger studies
Insights
Promising Phase 1 results show JNJ-1900 improved pancreatic cancer survival to 23 months vs 19.2 historical, with encouraging biomarker normalization.
The Phase 1 results for JNJ-1900 (NBTXR3) demonstrate several encouraging signals in a notoriously difficult-to-treat cancer. The median overall survival of 23 months represents a meaningful improvement over the historical 19.2 months at the same center for patients with locally advanced pancreatic cancer (LAPC), a patient population with historically dismal outcomes.
What's particularly notable is the CA19-9 normalization in 59% of patients compared to just 17% historically. CA19-9 is a well-established biomarker in pancreatic cancer, and its normalization strongly correlates with improved survival outcomes. Additionally, the association between increased circulating tumor mutational burden (cTMB) and improved progression-free and overall survival could potentially help identify patients most likely to benefit from this approach.
The ability to achieve R0 surgical resection in two patients with locally advanced disease is noteworthy, as these patients typically aren't surgical candidates. The favorable safety profile and injection feasibility address critical hurdles in pancreatic cancer treatment, where the anatomical location poses significant challenges.
This nanotherapeutic appears to effectively overcome the inherent radioresistance of pancreatic tumors. The advancement to a new cohort combining JNJ-1900 with standard chemoradiation represents a logical next step to potentially further enhance outcomes. While these results require validation in larger randomized studies, they provide a promising signal in a cancer type with urgent unmet needs.
Phase 1 pancreatic cancer trial shows 23-month survival with NBTXR3, superior biomarker normalization, and favorable safety profile warranting randomized study.
This MD Anderson-sponsored Phase 1 trial follows a methodical approach to investigating JNJ-1900 (NBTXR3) in pancreatic cancer. The study employed a novel strategy of replacing the chemotherapy component of standard chemoradiation with RT-activated NBTXR3 after induction chemotherapy.
The trial's design merits attention - while 20 of the 22 enrolled patients had locally advanced disease (typically associated with worse outcomes), the results still demonstrated a median overall survival of 23 months and median local progression-free survival of 13.3 months. The patient population is particularly challenging, making these efficacy signals more significant.
The exploratory biomarker analyses provide valuable insights for future development. The CA19-9 normalization rate of 59% versus a historical 17% is substantial, as this biomarker has established prognostic value in pancreatic cancer. The correlation between increased circulating tumor mutational burden and improved outcomes could potentially serve as a predictive biomarker to identify optimal candidates for this therapy.
The progression to a new cohort that combines NBTXR3 with standard concurrent chemoradiation represents a logical evolution in determining how to best integrate this nanotherapeutic into treatment paradigms. This measured, stepwise approach exemplifies sound clinical development strategy in a difficult disease space.
While these results are preliminary and from a small sample size, they provide sufficient evidence to justify the planned randomized study, which will more definitively evaluate the potential clinical benefit of this approach.
- Results demonstrated favorable safety, injection feasibility, and encouraging oncologic outcomes in patients (n=22) with locally advanced or borderline resectable pancreatic cancer
- Median Overall Survival of 23 months from date of diagnosis [
95% CI; 17 months – not reached] - Median Local Progression-Free Survival of 13.3 months from completion of radiation
- Notable findings observed in exploratory biomarker analyses include:
- An association between increased circulating tumor mutational burden (cTMB) and LPFS and OS
- CA19-9 normalization in
59% of patients in the study, and an association between CA19-9 normalization and OS
- First patient injected in a new cohort that adds standard-of-care concurrent chemotherapy (capecitabine or 5-FU) to radiotherapy-activated JNJ-1900 (NBTXR3) and recruitment is ongoing
- Investigators concluded that these results support further evaluation in a randomized study
Data presented at the 2025 Annual Meeting of the European Society of Radiation Oncology
PARIS and CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering nanotherapeutic approaches to improve treatment outcomes for patients with cancer, today announced the presentation of full results from the completed dose escalation and dose expansion phases of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer. The study, conducted by The University of Texas MD Anderson Cancer Center (“MD Anderson”), was presented by principal investigator Dr. Eugene Koay at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025).
Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies, driven by aggressive tumor biology and limited responsiveness to standard therapies. For patients with locally advanced (“LAPC”) or borderline resectable (“BRPC”) disease, the current standard-of-care (“SOC”)—induction chemotherapy followed by chemoradiation—rarely delivers curative outcomes, underscoring the need for novel treatment approaches.
“Patients with locally advanced or borderline resectable pancreatic cancer face a particularly urgent unmet need for therapeutic innovation that can provide a meaningful survival benefit with an acceptable safety profile,” said Eugene Koay, MD, PhD, Associate Professor of Radiation Oncology at MD Anderson. “We are encouraged by the results from the completed cohorts and look forward to the continued evaluation of JNJ-1900 (NBTXR3) in combination with standard-of-care chemoradiation after induction chemotherapy.”
PRESENTATION #E25-2265: NANORAY Pancreas: A Phase 1 Study of NBTXR3 (JNJ-1900) Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Cancer (LAPC or BRPC)
Koay EJ, Liu S, Guerrero P, Stokes E, Katz MHG, Ikoma N, Snyder RA, Tzeng CD, Overman MJ, Pant S, Wolff RA, Javle M, Holliday EB, Ludmir EB, Das P, Noticewala S, Koong AC, Tamm EP, Bhutani M
This MD Anderson-sponsored Phase 1 study evaluated the potential of radiotherapy(“RT”)-activated JNJ-1900 (NBTXR3) activated by radiation therapy (45 Gy in 15 fractions) to overcome inherent radioresistance in patients with LAPC or BRPC. The majority of patients in the study (20/22) were diagnosed with locally advanced, unresectable disease (LAPC). For clarity, patients with LAPC or BRPC are traditionally treated with induction chemotherapy followed by concurrent chemoradiation. The treatment regimen in the completed dose escalation and dose expansion parts of this Phase 1 study replaced concurrent chemoradiation with RT-activated JNJ-1900 (NBTXR3) after induction chemotherapy.
Key Results:
- Favorable safety profile and injection feasibility were observed (n=22)
- Median overall survival (“mOS”): 23 months from diagnosis [
95% CI; 17 months – not reached]- For context, an MD Anderson historical review of 144 patients with LAPC treated at the same center showed a mOS of 19.2 months. Patients in the historical review received induction chemotherapy followed by RT with or without concurrent or maintenance chemotherapy (
80% received RT with concurrent chemotherapy)
- For context, an MD Anderson historical review of 144 patients with LAPC treated at the same center showed a mOS of 19.2 months. Patients in the historical review received induction chemotherapy followed by RT with or without concurrent or maintenance chemotherapy (
- Median local progression-free survival (“mLPFS”): 13.3 months from completion of radiation
- Two LAPC patients achieved R0 surgical resection
Exploratory Biomarker Analyses:
- Of the 20 patients for whom circulating Tumor Mutational Burden (cTMB) data was available, a notable proportion (
40% ; 8/20) exhibited increased cTMB, and investigators observed an association between increased cTMB and improved LPFS and OS - Normalization of CA19-9, a surrogate for overall survival benefit, was observed in
59% of patients (11/22) and was associated with longer survival in the study.- For context, an MD Anderson historical review of 243 patients with LAPC treated at the same center showed normalization of CA19-9 in approximately
17% of patients treated with the standard of care who had elevated CA19-9 levels at diagnosis
- For context, an MD Anderson historical review of 243 patients with LAPC treated at the same center showed normalization of CA19-9 in approximately
Based on the safety and preliminary efficacy findings, investigators concluded that further evaluation of JNJ-1900 (NBTXR3) is warranted in a randomized study.
“Our collaboration with MD Anderson has always been driven by a shared commitment to exploring bold new approaches for patients with high unmet need,” said Louis Kayitalire, MD, Chief Medical Officer at Nanobiotix. “Given the extremely poor survival rates in LAPC and BRPC, the results from this Phase 1 study give us confidence in the potential of JNJ-1900 (NBTXR3) to serve as a meaningful addition to the treatment landscape. We are particularly excited about the potential to further enhance outcomes through combination of JNJ-1900 (NBTXR3) with SOC chemoradiation in the study’s new active cohort, and we look forward to advancing this program in pancreatic cancer.”
MD Anderson received FDA clearance to expand the study to include a new cohort that combines of JNJ-1900 (NBTXR3) with SOC concurrent chemoradiation after induction chemotherapy. The first patient in the new cohort has been injected, and recruitment is ongoing.
Nanobiotix Conference Call
Nanobiotix will host a conference call and webcast featuring Nanobiotix Chief Executive Officer and Chairman of the Executive Board, Laurent Levy, to discuss the data on Monday May 5th, 2025, at 8:00 AM EDT / 2:00 PM CEST.
Details for the call are as follows:
Webcast link: click here
Audio-only dial-in link: click here
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 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 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 Ricky Bhajun Director, Investor Relations +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 | |
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FAQ
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