NANOBIOTIX Announces First Patient Dosed in a New Randomized Phase 2 Study Evaluating JNJ-1900 (NBTXR3) for Patients With Stage 3 Unresectable Non-Small Cell Lung Cancer
Nanobiotix announced the dosing of the first patient in the CONVERGE study, a Phase 2 randomized controlled clinical trial evaluating JNJ-1900 (NBTXR3) for treating Stage 3 unresectable non-small cell lung cancer. The study will assess patients receiving standard chemoradiation followed by consolidation durvalumab.
The trial (NCT06667908) is sponsored by Janssen Pharmaceutica NV, a Johnson & Johnson Company, under a global license agreement. JNJ-1900 is a potential first-in-class radioenhancer designed to address unmet needs in radiotherapy patients. This development follows the NANORAY-312 trial path for potential registration in head and neck cancer.
Nanobiotix ha annunciato la somministrazione della prima dose al paziente nel CONVERGE study, uno studio clinico controllato randomizzato di Fase 2 che valuta JNJ-1900 (NBTXR3) per il trattamento del carcinoma polmonare non a piccole cellule di stadio 3 non resectabile. Lo studio valuterà i pazienti che ricevono chemioterapia e radioterapia standard seguite da durvalumab come trattamento consolidante.
Lo studio (NCT06667908) è sponsorizzato da Janssen Pharmaceutica NV, una società di Johnson & Johnson, sotto un accordo di licenza globale. JNJ-1900 è un potenziale radioenhancer di prima classe progettato per rispondere ai bisogni non soddisfatti dei pazienti in radioterapia. Questo sviluppo segue il percorso dello studio NANORAY-312 per una potenziale registrazione nel carcinoma testa-collo.
Nanobiotix anunció la dosificación del primer paciente en el estudio CONVERGE, un ensayo clínico controlado aleatorio de Fase 2 que evalúa JNJ-1900 (NBTXR3) para el tratamiento del cáncer de pulmón no microcítico en estadio 3 no resecable. El estudio evaluará a los pacientes que reciben quimioterapia y radiación estándar seguida de durvalumab como tratamiento de consolidación.
El ensayo (NCT06667908) es patrocinado por Janssen Pharmaceutica NV, una compañía de Johnson & Johnson, bajo un acuerdo de licencia global. JNJ-1900 es un posible radioenhancer de primera clase diseñado para abordar necesidades no satisfechas en pacientes de radioterapia. Este desarrollo sigue el camino del ensayo NANORAY-312 para una posible inscripción en cáncer de cabeza y cuello.
Nanobiotix는 CONVERGE 연구에서 첫 번째 환자의 투여를 발표했습니다. 이 연구는 3기 절제 불가능한 비소세포 폐암 치료를 위한 JNJ-1900 (NBTXR3)을 평가하는 2상 무작위 대조 임상 시험입니다. 이 연구는 표준 화학 요법과 방사선 치료 후 duraivalumab으로의 통합 치료를 받는 환자를 평가할 것입니다.
이 시험(NCT06667908)은 Janssen Pharmaceutica NV가 후원하며, Johnson & Johnson의 회사로서 글로벌 라이센스 계약에 따라 진행됩니다. JNJ-1900은 방사선 치료 환자의 unmet needs를 해결하기 위해 설계된 최초의 라디오 증강제로 기대되고 있습니다. 이번 개발은 두경부암 등록 가능성을 위한 NANORAY-312 시험 경로를 따릅니다.
Nanobiotix a annoncé la dose du premier patient dans l'étude CONVERGE, un essai clinique contrôlé randomisé de phase 2 évaluant JNJ-1900 (NBTXR3) pour traiter le cancer du poumon non à petites cellules de stade 3 non résécable. L'étude évaluera des patients recevant une chimiothérapie et une radiothérapie standard suivies d'une consolidation par durvalumab.
L'essai (NCT06667908) est parrainé par Janssen Pharmaceutica NV, une entreprise de Johnson & Johnson, dans le cadre d'un accord de licence mondial. JNJ-1900 est un potentiel radioenhancer de première classe conçu pour répondre aux besoins non satisfaits des patients en radiothérapie. Ce développement suit la voie de l'essai NANORAY-312 pour une éventuelle inscription dans le cancer de la tête et du cou.
Nanobiotix gab die Dosisverabreichung des ersten Patienten in der CONVERGE-Studie bekannt, einer Phase-2-randomisierten kontrollierten klinischen Studie zur Bewertung von JNJ-1900 (NBTXR3) zur Behandlung von nicht resektablem nicht-kleinzelligem Lungenkrebs im Stadium 3. Die Studie wird Patienten bewerten, die eine Standard-Chemoradiation gefolgt von einer Konsolidierung mit Durvalumab erhalten.
Die Studie (NCT06667908) wird von Janssen Pharmaceutica NV, einer Tochtergesellschaft von Johnson & Johnson, unter einem globalen Lizenzvertrag gesponsert. JNJ-1900 ist ein potenzieller radioenhancer der ersten Klasse, der entworfen wurde, um unzureichende Bedürfnisse von Patienten in der Strahlentherapie zu adressieren. Diese Entwicklung folgt dem Pfad der NANORAY-312-Studie für eine potenzielle Zulassung bei Kopf-Hals-Krebs.
- Expansion of JNJ-1900 clinical development into non-small cell lung cancer market
- Partnership with major pharmaceutical company (Johnson & Johnson) executing the trial
- Clear registration pathway established through NANORAY-312 trial
- None.
Insights
The initiation of the Phase 2 CONVERGE study represents a strategic expansion of JNJ-1900's clinical development program into non-small cell lung cancer (NSCLC), the most common type of lung cancer. The study's focus on Stage 3 unresectable NSCLC targets a significant unmet medical need, as these patients typically have poor prognoses with current standard treatments.
The trial design combining JNJ-1900 with both chemoradiation and durvalumab is particularly noteworthy. This approach aims to potentially enhance the efficacy of the current standard of care by leveraging JNJ-1900's radioenhancement properties. The backing of Janssen Pharmaceutica NV provides substantial resources and expertise for the trial's execution.
For a simplified explanation: Think of JNJ-1900 as a microscopic amplifier that could make radiation therapy work better. It's like turning up the volume on radiation's cancer-fighting effects while keeping the side effects at the same level. This could be especially helpful for lung cancer patients who can't have surgery to remove their tumors.
This development carries substantial market implications. The NSCLC market represents a multi-billion dollar opportunity, significantly larger than the head and neck cancer market where JNJ-1900 is already in late-stage development. Johnson & Johnson's involvement through Janssen adds considerable value through their global commercialization capabilities and financial resources.
The expansion into NSCLC diversifies NBTX's potential revenue streams and reduces clinical development risk. With a market cap of
In simple terms: This is like opening a second, potentially bigger store while having a strong business partner cover most of the costs. The partner's reputation and resources increase the chances of success, while NBTX could profit from both ventures.
PARIS and CAMBRIDGE, Mass., Jan. 21, 2025 (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 that the first patient has been dosed in the CONVERGE study, a Phase 2 randomized controlled clinical trial evaluating potential first-in-class radioenhancer JNJ-1900 (NBTXR3) for the treatment of patients with Stage 3 unresectable non-small cell lung cancer receiving standard of care chemoradiation followed by consolidation durvalumab (NCT06667908). CONVERGE is sponsored by Janssen Pharmaceutica NV, a Johnson & Johnson Company, under a global license agreement.
“We believe the true value of JNJ-1900 (NBTXR3) is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment,” said Laurent Levy, Nanobiotix Chief Executive Officer and Chairman of the Executive Board. “With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in non-small cell lung cancer brings us another step closer to delivering for the large number of patients JNJ-1900 (NBTXR3) is designed to serve.”
About 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 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 | |
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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FAQ
What is the purpose of Nanobiotix's CONVERGE Phase 2 trial for NBTX stock?
Who is sponsoring the Phase 2 CONVERGE trial for NBTX's JNJ-1900?
What is the current development stage of NBTX's JNJ-1900 in January 2025?
What treatment combination is being tested in the NBTX CONVERGE study?
