NANOBIOTIX Announces Completion of Phase 1 Study of NBTXR3 (JNJ-1900) in Pancreatic Cancer
Nanobiotix announced completion of Phase 1 study evaluating RT-activated NBTXR3 in pancreatic cancer patients. The study showed encouraging results with 23 months median Overall Survival from diagnosis in 22 patients with locally advanced or borderline resectable pancreatic cancer, compared to 19.2 months historical control at MD Anderson.
The treatment was well-tolerated, and investigators concluded the favorable safety profile and oncologic outcomes warrant further evaluation in a randomized trial. The FDA approved a protocol amendment to launch a new cohort studying NBTXR3 combined with standard-of-care concurrent chemotherapy, with recruitment currently ongoing. Full data presentation is expected at a medical congress in first half of 2025.
Nanobiotix ha annunciato il completamento dello studio di Fase 1 che valuta l'NBTXR3 attivato da RT in pazienti con cancro pancreatico. Lo studio ha mostrato risultati incoraggianti con una mediana di sopravvivenza globale di 23 mesi dalla diagnosi in 22 pazienti con cancro pancreatico localmente avanzato o borderline resecabile, rispetto a 19,2 mesi nel gruppo di controllo storico presso il MD Anderson.
Il trattamento è stato ben tollerato, e i ricercatori hanno concluso che il profilo di sicurezza favorevole e i risultati oncologici meritano ulteriori valutazioni in uno studio randomizzato. La FDA ha approvato un emendamento al protocollo per avviare una nuova coorte che studia NBTXR3 combinato con chemioterapia standard in contemporanea, con le arruolazioni attualmente in corso. La presentazione completa dei dati è prevista in un congresso medico nella prima metà del 2025.
Nanobiotix anunció la finalización del estudio de Fase 1 que evalúa el NBTXR3 activado por RT en pacientes con cáncer de páncreas. El estudio mostró resultados alentadores con una mediana de supervivencia global de 23 meses desde el diagnóstico en 22 pacientes con cáncer de páncreas localmente avanzado o resecable límite, en comparación con los 19,2 meses del grupo de control histórico en MD Anderson.
El tratamiento fue bien tolerado, y los investigadores concluyeron que el perfil de seguridad favorable y los resultados oncológicos justifican una evaluación adicional en un ensayo aleatorizado. La FDA aprobó una enmienda al protocolo para lanzar una nueva cohorte que estudia NBTXR3 combinado con quimioterapia estándar concurrente, con el reclutamiento actualmente en curso. Se espera una presentación completa de los datos en un congreso médico en la primera mitad de 2025.
Nanobiotix는 췌장암 환자에서 RT 활성화된 NBTXR3를 평가하는 1상 연구를 완료했다고 발표했습니다. 이 연구는 국소 진행성 또는 경계 재수술 가능한 췌장암 환자 22명에서 진단 후 23개월의 중앙 전체 생존률을 보였으며, 이는 MD Anderson에서의 19.2개월의 역사적 대조군과 비교됩니다.
치료는 잘 견뎌졌으며, 연구자들은 안전성이 우수하고 종양학적 결과가 우 favorable 평가를 보완할 필요가 있음을 결론지었습니다. FDA는 NBTXR3과 표준 동반 화학요법을 결합한 새로운 코호트를 연구하는 프로토콜 수정안을 승인하였으며, 현재 모집이 진행 중입니다. 전체 데이터 발표는 2025년 상반기 의학 회의에서 기대됩니다.
Nanobiotix a annoncé l'achèvement d'une étude de Phase 1 évaluant le NBTXR3 activé par RT chez des patients atteints de cancer du pancréas. L'étude a montré des résultats encourageants avec une médiane de survie globale de 23 mois depuis le diagnostic chez 22 patients souffrant de cancer du pancréas localement avancé ou borderline résécable, contre 19,2 mois dans le groupe témoin historique au MD Anderson.
Le traitement a été bien toléré et les enquêteurs ont conclu que le profil de sécurité favorable et les résultats oncologiques justifient une évaluation supplémentaire dans un essai randomisé. La FDA a approuvé un amendement de protocole pour lancer une nouvelle cohorte étudiant le NBTXR3 associé à la chimiothérapie standard en cours, dont le recrutement est actuellement en cours. Une présentation complète des données est attendue lors d'un congrès médical dans la première moitié de 2025.
Nanobiotix hat den Abschluss der Phase-1-Studie bekannt gegeben, die NBTXR3, aktiviert durch RT, bei Patienten mit Bauchspeicheldrüsenkrebs bewertet. Die Studie zeigte ermutigende Ergebnisse mit einer medianen Überlebensrate von 23 Monaten seit der Diagnose bei 22 Patienten mit lokal fortgeschrittenem oder grenzwertig resezierbarem Bauchspeicheldrüsenkrebs, im Vergleich zu 19,2 Monaten der historischen Kontrollgruppe am MD Anderson.
Die Behandlung wurde gut toleriert, und die Forscher kamen zu dem Schluss, dass das günstige Sicherheitsprofil und die onkologischen Ergebnisse eine weitere Evaluierung in einer randomisierten Studie rechtfertigen. Die FDA genehmigte eine Protokolländerung zur Einleitung einer neuen Kohorte, die NBTXR3 in Kombination mit der derzeitigen Standard-Chemotherapie untersucht, die aktuell rekrutiert wird. Eine vollständige Datenpräsentation wird im ersten Halbjahr 2025 auf einem medizinischen Kongress erwartet.
- 23 months median Overall Survival achieved, exceeding historical control of 19.2 months
- Treatment demonstrated favorable safety profile with good tolerability
- FDA approved protocol amendment for new study cohort
- Successful completion of Phase 1 study with encouraging oncologic outcomes
- None.
Insights
- Investigators concluded that the encouraging oncologic outcomes coupled with a favorable safety profile warrant further evaluation in a randomized trial
- 23 months median Overall Survival from date of diagnosis was observed in 22 patients with locally advanced or borderline resectable pancreatic cancer
- US FDA approved protocol amendment to launch new cohort evaluating RT-activated NBTXR3 combined with standard-of-care concurrent chemotherapy and recruitment is ongoing
- Full data from the completed dose escalation and dose expansion cohorts to be presented at a medical congress in 1H 2025
PARIS and CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced the completion of the dose escalation and dose expansion parts of a Phase 1 study evaluating radiotherapy(“RT”)-activated NBTXR3 (JNJ-1900) for patients with locally advanced pancreatic cancer (“LAPC”) or borderline resectable pancreatic cancer (“BRPC”). The Phase 1 study is being conducted by The University of Texas MD Anderson Cancer Center (“MD Anderson”).
Patients with LAPC or BRPC often receive initial treatment with cytotoxic chemotherapy followed by RT +/- concurrent or maintenance chemotherapy.
This Phase 1 study was designed to evaluate the safety, feasibility, and early signs of efficacy of RT-activated NBTXR3 for patients with LAPC or BRPC after initial treatment with cytotoxic chemotherapy, in comparison to the historical data in patients who received RT +/- concurrent or maintenance chemotherapy after initial treatment with cytotoxic chemotherapy.
Investigators observed an mOS of 23 months from the date of diagnosis in 22 patients (20 with LAPC and 2 with BRPC) on the trial that compared favorably with outcomes at MD Anderson where the historical control for mOS in 144 patients treated at the same center was 19.2 months. Investigators concluded that RT-activated NBTXR3 was well tolerated by all patients and that the encouraging oncologic outcomes observed warrant further evaluation in a randomized trial.
Following these encouraging results from the study, MD Anderson submitted and received US FDA clearance for a new, additional study cohort evaluating the combination of NBTXR3 and standard-of-care concurrent chemoradiation. The new cohort has launched, and recruitment is ongoing.
“The results we have observed in this Phase 1 study give us confidence that NBTXR3 could have a significant impact for these patients,” said Louis Kayitalire, MD, Chief Medical Officer at Nanobiotix. “We look forward to the data from the new cohort and believe the combination of NBTXR3 and concurrent chemoradiation could produce even more favorable outcomes for patients with locally advanced or borderline resectable pancreatic cancer.”
Nanobiotix expects full results from the completed dose escalation and dose expansion parts of the study to be presented by MD Anderson at a medical congress in 1H 2025.
About 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.
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 | |
FR – Ulysse Communication Laurent Wormser + 33 (0)6 13 12 04 04 lwormser@ulysse-communication.com | Global – LifeSci Advisors Kevin Gardner +1 (617) 283-2856 kgardner@lifesciadvisors.com |
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