Phase 3 Head and Neck Cancer Trial for NBTXR3 Now Fully Transferred to J&J—Interim Results Expected by 1H 2027
J&J Takes the Helm on Pivotal NANORAY-312 Trial—Key Milestone in NBTXR3’s Journey
In a significant clinical development update, Nanobiotix has announced the completion of both sponsorship and full operational control transfer for the global Phase 3 NANORAY-312 trial of JNJ-1900 (NBTXR3) to Johnson & Johnson. This milestone follows an agreement that initiated in the third quarter of 2024 and spans the majority of regions involved in the trial. With the transition finalized, Nanobiotix projects that interim data from the pivotal study will be available by the first half of 2027—pending accrual of key trial events and last patient recruitment.
NBTXR3: Expanding Potential Across Solid Tumors with Unique Mechanism of Action
JNJ-1900 (NBTXR3) represents a potentially first-in-class oncology innovation—engineered from functionalized hafnium oxide nanoparticles, administered via a single intratumoral injection, and activated by radiotherapy. Its design targets not only immediate tumor cell death but also triggers an adaptive immune response that could translate into long-term anti-cancer effects. The product’s scalability—spanning various solid tumors and compatibility with immune checkpoint inhibitors—sets it apart in the crowded landscape of cancer therapies.
Regulatory Momentum and Broad Global Development—Fast Track Designation Supports Urgency
The FDA has already granted NBTXR3 Fast Track status for its use in head and neck cancer patients who cannot undergo platinum-based chemotherapy, echoing the population at the heart of the NANORAY-312 study. With operational control now in Johnson & Johnson’s hands, the broader clinical program continues to advance through a comprehensive development partnership network, including multiple Phase 1 and 2 trials led in collaboration with MD Anderson Cancer Center.
What’s Next? Data, Oversight, and Continued Global Expansion
Moving forward, Johnson & Johnson will oversee communication on all NBTXR3 trials it sponsors, while Nanobiotix maintains updates on its own research initiatives and those conducted by MD Anderson. The immediate market focus centers on the upcoming NANORAY-312 readout, expected by 1H 2027, a pivotal catalyst that could shape the commercial path for NBTXR3 in a broad spectrum of solid tumors.
| Key Program Details | Status / Timeline |
|---|---|
| Phase 3 Head & Neck Cancer Trial (NANORAY-312) | Sponsorship/Control transferred to J&J; Interim results expected 1H 2027 |
| Global Development Partners | Johnson & Johnson; MD Anderson Cancer Center |
| FDA Fast Track Designation | Granted for use in platinum-ineligible HNSCC patients |
| Clinical Expansion | Ongoing across multiple solid tumor types, as monotherapy and combination |
Why This Matters for Patients and Investors
The completed transfer of NANORAY-312 sets the stage for accelerated clinical and regulatory progress—particularly significant given the long-term vision for NBTXR3 as a broadly applicable cancer therapy. For stakeholders watching the space, interim data in 2027 could mark a turning point not just for Nanobiotix, but for the future landscape of radiotherapy-activated treatments.
Key Contacts for Further Information
| Department | Contact | Details |
|---|---|---|
| Communications | Brandon Owens, VP | +1 (617) 852-4835, contact@nanobiotix.com |
| Investor Relations (US) | Joanne Choi, VP | +1 (713) 609-3150, investors@nanobiotix.com |
| Investor Relations (EU) | Ricky Bhajun, Director | +33 79 97 29 99, investors@nanobiotix.com |
| Media Relations (France) | Caroline Hardy | +33 06 70 33 49 50, carolinehardy@outlook.fr |
| Media Relations (Global) | Becky Lauer | +1 (646) 286-0057, nanobiotixteam@uncappedcommunications.com |
For more detailed information and future clinical updates, visit www.nanobiotix.com.
Contact Information:
If you have feedback or concerns about the content, please feel free to reach out to us via email at support@marketchameleon.com.
About the Publisher - Marketchameleon.com:
Marketchameleon is a comprehensive financial research and analysis website specializing in stock and options markets. We leverage extensive data, models, and analytics to provide valuable insights into these markets. Our primary goal is to assist traders in identifying potential market developments and assessing potential risks and rewards.
NOTE: Stock and option trading involves risk that may not be suitable for all investors. Examples contained within this report are simulated and may have limitations. Average returns and occurrences are calculated from snapshots of market mid-point prices and were not actually executed, so they do not reflect actual trades, fees, or execution costs. This report is for informational purposes only, and is not intended to be a recommendation to buy or sell any security. Neither Market Chameleon nor any other party makes warranties regarding results from its usage. Past performance does not guarantee future results. Please consult a financial advisor before executing any trades. You can read more about option risks and characteristics at theocc.com.
The information is provided for informational purposes only and should not be construed as investment advice. All stock price information is provided and transmitted as received from independent third-party data sources. The Information should only be used as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments and trading strategies. The Company does not guarantee the accuracy, completeness or timeliness of the Information.
Disclosure: This article was generated with the assistance of AI