New Cancer Drug Stops Disease in 85% of Patients, Sparking a 10% Stock Jump for J&J’s $2.6 Billion Partner
The world of clinical trials, constantly scrutinizing new therapies for advanced diseases, recently witnessed significant developments in oncology, highlighted by Nanobiotix's radiotherapy-activated cancer drug, JNJ-1900. This drug, previously known as NBTXR3, and co-developed through an exclusive licensing agreement with Johnson & Johnson (J&J), has demonstrated compelling results in a Phase I trial for oesophageal cancer. The news, reported by Clinical Trials Arena, underscores the potential expansion of JNJ-1900's role beyond its primary positioning in head and neck cancer, triggering immediate financial ramifications for the company.
Clinical Trials Arena serves as a platform for disseminating critical information related to clinical trials, covering various sectors and themes, including Data Management, Outsourced Services, Supply Chain, and specific technological themes like Artificial Intelligence (AI), Cloud, Internet of Things (IoT), and Robotics. Its content includes News, Analysis, Features, and Data Insights, alongside collaborations such as those "From Our Partners," which includes discussions on simplifying clinical data processes and accelerating clinical trials. Reporting on the late-stage drug JNJ-1900’s success is a core component of its coverage.
Clinical Efficacy: A Strong Foundation in Oesophageal Cancer
The primary focus of the recent report is the outcome of the Phase I trial (NCT04615013), which tested JNJ-1900 in patients with oesophageal cancer. The drug is a nanoparticle-based injectable and is activated by radiotherapy. In this early-stage study, patients received the intratumoural drug combination with either proton chemoradiotherapy (CRT) or photon CRT.
The results demonstrated strong signals of efficacy, particularly in achieving disease control and response. The Phase I trial showed a disease control rate (DCR) of 85%. Furthermore, JNJ-1900 triggered an objective response rate (ORR) of 69%. These response rates are indicative of the drug’s potential, suggesting a significant therapeutic effect when combined with chemoradiotherapy.
Dr. Steven Lin, the principal investigator for the study and a radiation oncology professor at MD Anderson, noted the significance of these findings. Lin specifically highlighted observing "encouraging rates of disease control and complete response". The data confirmed that among the patients who responded to the treatment, six achieved a complete response (CR), which represents the disappearance of all signs of cancer. Additionally, three patients experienced biopsy-confirmed partial responses (PR).
These clinical milestones are crucial because they suggest that JNJ-1900, if successfully developed, could help improve local tumour control. Critically, the drug offers the potential benefit of "potentially sparing patients from the risks … of esophagectomy". This aligns with Nanobiotix’s claim that JNJ-1900 can address the unmet need in oesophageal cancer treatment by potentially reducing reliance on invasive surgical procedures. The standard of care (SoC) regimen currently revolves around radiotherapy, chemoradiation, and surgery, which can have a distinct impact on patient quality of life (QoL). With approximately 572,000 patients diagnosed with oesophageal cancer annually, the need for less invasive and more effective treatment options is substantial.
Feasibility, Tolerability, and the Future Pipeline
Beyond efficacy, the Phase I study was critical for assessing the safety and feasibility of the JNJ-1900 combination. The study proved that combining JNJ-1900 and photon CRT was both feasible and well tolerated.
However, as is common in clinical trials, patients did experience adverse events. All patients involved in the study experienced some form of treatment-emergent adverse event (TEAE) during the trial. Specifically, six patients experienced events related to the drug itself. Of these six patients, two experienced Grade 3 and above TEAEs related to the drug. Importantly, no AEs were reported post-injection procedure, and none of the patients experienced Grade 3 and above impact due to the injection procedure itself. This safety profile, combined with the encouraging rates of disease control and complete response, provides a "strong foundation for further investigation," according to Principal Investigator Steven Lin.
The promising Phase I results have set the stage for the next steps in JNJ-1900’s development. Moving forward, Nanobiotix and J&J will continue recruiting patients for the Phase I dose escalation trial. Following this, the dose expansion portion of the study will commence. A recommended dose has already been set for JNJ-1900, which is welcome news for J&J. Although Nanobiotix has not yet specified if or when it will begin Phase II trials for JNJ-1900 in oesophageal cancer, the successful Phase I outcome has already significantly broadened the drug’s potential indications outside of its initial primary positioning in head and neck cancer.
The Corporate Landscape: J&J’s $2.6 Billion Commitment
The success of JNJ-1900 is directly tied to a major strategic partnership between Nanobiotix and the New Jersey-based big pharma, Johnson & Johnson. J&J signed an exclusive co-development and licensing agreement for NBTXR3 (JNJ-1900) in 2023. This extensive deal was valued at approximately $2.6 billion, a figure solidified after a $100 million agreement tweak in March 2025.
Under the updated agreement, J&J has committed to covering all the costs associated with the pivotal NANORAY-312 study (NCT04892173). This pivotal study is focused on assessing JNJ-1900 in its primary indication: head and neck squamous cell carcinoma (HNSCC). In exchange for J&J assuming the costs of the NANORAY-312 study, Nanobiotix has cancelled select milestone payments moving forward. Nanobiotix currently estimates that interim analyses for the drug’s efficacy specifically in HNSCC will be available in H1 2026.
The partnership extends beyond just oesophageal cancer and HNSCC. Nanobiotix and J&J are actively exploring JNJ-1900 across five ongoing clinical trials in advanced solid tumours. These trials include studies targeting non-small cell lung cancer (NSCLC), pancreatic cancer, and recurrent HNSCC.
Market Reaction and Competitive Advantage
The positive news regarding the oesophageal cancer trial immediately resonated with the investment community. Following the debut of the news, Nanobiotix’s stock value rose 10%. The stock increased from $18.86 at market open on October 1 to $20.79 at market open on October Investors, it seems, agreed that the early findings provided a strong foundation for further investigation.
Despite the strong early data, if JNJ-1900 were to make it to market in the oesophageal cancer indication, it would enter a challenging and competitive therapeutic space. It would face stiff competition from a wide array of US Food and Drug Administration (FDA)-approved targeted therapies already available.
Key competitors include MSD’s oncology blockbuster, Keytruda (pembrolizumab), which was 2024's best-selling drug. Additionally, the competition includes BMS' Opdivo (nivolumab) plus Yervoy (ipilimumab).
However, JNJ-1900 possesses characteristics that could grant it a crucial competitive edge over these targeted therapies, such as Keytruda. JNJ-1900 is noted for its immune-stimulating radiation sensitising activity. This mechanism means its use may be particularly suitable for patients who are refractory to current treatment options like targeted therapies. By offering a viable alternative for patients who do not respond to existing standards, JNJ-1900 could carve out a valuable niche in the competitive oncology landscape.
Summary of Clinical Trials Arena Insights
The report from Clinical Trials Arena highlights the complex interplay between advanced science, strategic corporate governance, and urgent unmet patient needs. The publication provides continuous insights, including reports on other major catalysts, such as trials in Alzheimer’s disease and other therapeutic wins for companies like UniQure.
The current findings regarding JNJ-1900 showcase the drug's powerful potential in oesophageal cancer, marked by a 69% ORR and 85% DCR, suggesting a new path forward that may reduce the reliance on invasive surgical procedures like esophagectomy. Supported by the substantial $2.6 billion commitment from J&J, the trajectory of JNJ-1900 across multiple advanced solid tumours, with interim HNSCC data expected in H1 2026, establishes it as a major compound to monitor in the coming years. The early positive signals, confirming feasibility and strong response rates in Phase I, validate the high stakes and the significant investment made in this radiotherapy-activated nanoparticle technology.
The overarching mission of reporting, as demonstrated by Clinical Trials Arena, is to provide deep insights and hard data on clinical trials strategy and operations, giving businesses an edge with leading industry insights. The coverage of JNJ-1900’s expansion from its primary HNSCC focus into oesophageal cancer, driven by its immune-stimulating mechanism and promise of sparing patients from surgery, provides essential information for professionals across the sector.
Cancer Researchers:
Geoffrey Buckle, MD, MPH
Dr. Geoffrey Buckle is an Assistant Professor of Medicine at the University of California, San Francisco (UCSF), where he specializes as a gastrointestinal medical oncologist. His research focuses on the etiology, early detection, and treatment of esophageal squamous cell carcinoma (ESCC), particularly within Eastern Africa. A board member of the African Esophageal Cancer Consortium (AfrECC), he collaborates with researchers in Africa and globally to address the burden of this disease. He has been recognized with the Conquer Cancer Foundation/American Society of Clinical Oncology Global Oncology Young Investigator Award for his work.
Violet Kayamba, MD, PhD
Dr. Violet Kayamba is an internist and gastroenterologist and is a Senior Lecturer at the University of Zambia School of Medicine. As an expert in gastrointestinal cancers, she serves as the president of the Zambia College of Gastroenterology and Nutrition and is a founding member of the African Esophageal Cancer Consortium (AfrECC). Her work focuses on clinical research and care for esophageal cancer patients, bringing a specialized clinical and research perspective to the fight against the disease in Africa.
Michael Mwachiro, MD
Dr. Michael Mwachiro is a Consultant General Surgeon and Interventional Endoscopist based in Nairobi, Kenya. As a founder and board member of the African Esophageal Cancer Consortium (AfrECC), his research focuses on surgical education and gastrointestinal malignancies, especially esophageal cancer. Dr. Mwachiro has published extensively on topics including early detection, palliation, and treatment of esophageal cancer, and he conducted the first esophageal cancer screening study in Africa using Lugol's Chromoendoscopy.
