Hafnium oxide nanoparticles

PARIS and CAMBRIDGE, Mass., Oct. 24, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced updates to the JNJ-1900 (NBTXR3) clinical development program. Nanobiotix has completed the transfer of NANORAY-312 sponsorship, initiated in 3Q2024, in the majority of regions along with the transfer of full operational control of the Phase 3 clinical trial to Johnson & Johnson (“J&J”). Following the transfer and Nanobiotix analysis of the latest information, Nanobiotix estimates that NANORAY-312 interim data will be analyzed and reported, after both the requisite number of events have been observed and the last patient has been recruited, in 1H2027. Future guidance related to NANORAY-312 and other JNJ-1900 (NBTXR3)-related J&J-sponsored studies will be communicated by J&J. Nanobiotix will continue to provide JNJ-1900 (NBTXR3) clinical development updates and guidance related to Nanobiotix-sponsored studies as well as studies sponsored by The University of Texas MD Anderson Cancer Center. 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 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 2, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 2, 2025 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2025 which are available on the SEC’s website at www.sec.gov and on the AMF's website at www.amf.org, 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 Attachment 2025-10-24 -- NBTX -- Update to NBTXR3 Clinical Program -- FINAL

Equity Insider News Commentary Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Oct. 7, 2025 /PRNewswire/ -- Equity InsiderNews Commentary – Major pharmaceutical companies presenting at the European Society for Medical Oncology Congress October 17-21[1] are unveiling pivotal survival data[2] and late-breaking lung cancer[3] results that demonstrate how diverse mechanisms are succeeding where traditional approaches stalled, while regulatory agencies issued multiple September approvals spanning gene therapies, bispecifics, and novel delivery systems[4]. The momentum reflects a fundamental shift as researchers discovered how cancer hijacks immune pathways to evade attack, spurring development of targeted platforms that activate natural killer cells, enhance radiation effects, detect disease earlier, and deploy bispecific antibodies against previously undruggable targets[5]. Clinical-stage developers advancing these differentiated mechanisms include GT Biopharma, Inc. (NASDAQ: GTBP), I-Mab (NASDAQ: IMAB), enGene Holdings Inc. (NASDAQ: ENGN), Onconetix, Inc. (NASDAQ: ONCO), and Nanobiotix S.A. (NASDAQ: NBTX). With HHS doubling federal funding for cancer research to $100 million[6] and multiple companies reporting pivotal trial data across blood cancers, gastric malignancies, bladder cancer, pancreatic detection, and esophageal tumors, institutional capital is flowing toward platforms addressing the 60-70% of patients who don't respond to standard checkpoint inhibitors. The convergence of immune activation technologies, precision diagnostics, gene therapies, and nanoparticle-enhanced radiation creates favorable conditions for early-positioned companies with clinical-stage assets proving efficacy in historically resistant cancer types before major consolidation accelerates in these emerging categories. GT Biopharma, Inc. (NASDAQ: GTBP) is a clinical-stage immunotherapy company making significant progress in its fight against difficult-to-treat cancers. The San Francisco-based biotech has been advancing its lead drug candidate, GTB-3650, through a Phase 1 clinical trial targeting blood cancers that have stopped responding to other treatments. In August, the company successfully moved into Cohort 3 after formal safety reviews of the first two patient groups showed no safety or tolerability problems. The trial had treated five patients by mid-August, with encouraging early signals of immune system activation. "We are pleased with the enrollment momentum in our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which continues to advance on schedule," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "Moving into the third dose cohort after a successful safety review and encouraging early evidence of immunological activity, mark important steps forward in the development of GTB-3650. We look forward to sharing more data later this year to reinforce the ability of our TriKE constructs to activate endogenous NK cells, and the potential for broader utility with other targets to treat solid tumors (GTB-5550) and autoimmune indications (GTB-7550)." The Phase 1 trial is testing GTB-3650 in patients with relapsed or refractory CD33-expressing blood cancers, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These are patients whose cancers have come back or never responded to standard therapies. The drug works by activating the body's own natural killer cells to attack cancer cells. Patients receive the treatment through continuous infusions in two-week cycles, alternating two weeks on and two weeks off, for up to four months based on how well they're responding. What makes the early data particularly interesting is the biomarker evidence. Multiple blood tests from the first four patients showed measurable increases in natural killer cell activity and expansion. This suggests the drug is doing exactly what it was designed to do—wake up the immune system and direct it against cancer. GT Biopharma expects to release more detailed Phase 1 results later this year after completing additional dose cohorts. Beyond blood cancers, GT Biopharma has a second drug candidate moving toward the clinic. GTB-5550 targets a protein called B7H3 that appears in many different types of solid tumors, including breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers. The company expects to submit its application to start human testing of GTB-5550 during the fourth quarter of this year. Unlike many cancer immunotherapies that require lengthy hospital infusions, GTB-5550 is being developed as a simple injection that patients could potentially give themselves at home, similar to insulin shots. Both drug candidates are built on GT Biopharma's proprietary TriKE platform, which uses specialized antibody fragments originally discovered in camels and llamas. These molecules are smaller and more stable than traditional antibodies, allowing them to work more effectively. GT Biopharma holds an exclusive worldwide license from the University of Minnesota to develop and commercialize therapies using this technology. As of June 30, 2025, GT Biopharmareported cash and cash equivalents of approximately $5.3 million, which management expected would fund operations into the first quarter of 2026. CONTINUED… Read this and more news for GT Biopharma, Inc. at: I-Mab (NASDAQ: IMAB) has announced accelerated investment in givastomig, its lead Claudin 18.2-directed bispecific antibody, with plans to initiate a global randomized Phase 2 study in first-line metastatic gastric cancers in Q1 2026. The company expects to report Phase 1b dose expansion data in Q1 2026 and is expanding development into additional Claudin 18.2-positive tumor types including biliary tract cancer and pancreatic ductal adenocarcinoma. "2025 has been a year of significant progress for I-Mab. Compelling Phase 1b combination data and positive investigator engagement have accelerated the givastomig program and reinforced our confidence in its potential to be a best-in-class Claudin 18.2-directed therapy for metastatic gastric cancers in the 1L setting," said Sean Fu, PhD, CEO of I-Mab. "Based on these accomplishments, we are expanding our investment in givastomig, with plans to initiate a randomized Phase 2 study in Q1 2026." I-Mab appointed Wei Fu as Executive Chairman and Dr. Sean Cao as Chief Business Development Officer to support the company's growth initiatives. With cash and marketable securities of $224.9 million expected to fund operations into 2027, the company is positioned to advance its precision immuno-oncology pipeline through multiple clinical milestones. enGene Holdings Inc. (NASDAQ: ENGN) achieved target enrollment of 100 patients in the pivotal cohort of its LEGEND Phase 2 trial evaluating detalimogene voraplasmid in high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The company was granted Regenerative Medicine Advanced Therapy designation by the FDA and plans to provide a data update from the pivotal cohort in 4Q 2025, positioning for a Biologics License Application submission in 2H 2026. "Reaching target enrollment in LEGEND's pivotal Cohort 1 and securing RMAT designation are important milestones that mark our continued momentum," said Ron Cooper, CEO of enGene Holdings Inc. "We look forward to providing a data update from the LEGEND pivotal cohort later this year. These advances bring us closer to our planned BLA filing in 2026 with the ultimate goal of delivering detalimogene to patients as a therapy designed for efficacy, safety, and ease-of-use." The company reported third quarter 2025 net loss of $28.9 million, or $0.57 per share, driven by increased manufacturing and clinical costs related to the LEGEND study. With cash, cash equivalents and marketable securities of $224.9 million as of July 31, 2025, enGene expects to fund operating expenses and capital expenditures into 2027. Onconetix, Inc. (NASDAQ: ONCO) announced that its wholly owned subsidiary Proteomedix has signed a licensing agreement with Immunovia AB to provide manufacturing intellectual property for the PancreaSure pancreatic cancer test. Under the agreement, Immunovia will make payments totaling $700,000 to Proteomedix in 2025 and 2026, plus a 3% royalty on net sales of PancreaSure from 2026 to 2032. "We are proud to have contributed to the development of PancreaSure and are excited to now support its manufacturing," said Beat Rheiner, PhD, CEO of Proteomedix. "Earlier detection of pancreatic cancer through PancreaSure gives patients real hope for better outcomes." The licensing agreement enables Immunovia to independently produce antibodies related to three of the five biomarkers included in PancreaSure while Onconetix continues to focus on commercializing Proclarix, its CE-certified in vitro diagnostic test for prostate cancer. Proteomedix will provide master cells and key manufacturing intellectual property to support the production of reagents for the pancreatic cancer diagnostic test. Nanobiotix S.A. (NASDAQ: NBTX) reported first Phase 1 data from its dose escalation study evaluating JNJ-1900 (NBTXR3) in 13 patients with locally advanced esophageal adenocarcinoma, demonstrating an 85% disease control rate and 69% objective response rate with 6 complete responses and 3 partial responses. The treatment, which combines hafnium oxide nanoparticles activated by radiotherapy with concurrent chemotherapy, was well-tolerated with the recommended Phase 2 dose established at 33% of gross tumor volume for photon chemoradiation. "Esophageal cancer remains one of the most difficult contexts for both patients and clinicians, where existing standards of care can create significant burdens for patients," said Louis Kayitalire, Chief Medical Officer at Nanobiotix. "We believe that JNJ-1900 (NBTXR3), through its broadly applicable mechanism of action, could offer a novel approach—one designed to enhance local control and potentially reduce the need for highly invasive procedures such as esophagectomy." The study, sponsored by The University of Texas MD Anderson Cancer Center, is actively recruiting 17 additional patients for dose escalation and expansion cohorts evaluating both photon and proton chemoradiation followed by surgery. Nanobiotix is developing JNJ-1900 (NBTXR3) in collaboration with Janssen Pharmaceutica NV, a Johnson & Johnson company, with the potential to expand into new indications for locally advanced esophageal cancer and additional activation modalities beyond standard radiation therapy. Article Sources: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. 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