Nanobiotix Updates on NBTXR3 Development, Emphasizes Strong Pipeline and Growth Path

Nanobiotix, a biotechnology company focused on nanoparticle-based therapeutic approaches, has unveiled updates to its corporate strategy aimed at fostering long-term growth. The company’s primary candidate, NBTXR3, is at the forefront of this strategy, with a focus on advancing its development and commercialization efforts.

Nanobiotix is developing three nanoparticle-based therapy platforms sequentially. NBTXR3, a potential first-in-class radio-enhancing agent, is the leading candidate from the first platform. This therapeutic is being developed and potentially marketed in collaboration with Janssen Pharmaceutica NV, a Johnson & Johnson company. The anticipated revenue from NBTXR3's development and commercialization will be used to further the development of the other two platforms.

Laurent Levy, Nanobiotix's CEO, emphasized the company's commitment to realizing the medical and economic value of NBTXR3. He highlighted the company's 20-year history of achievements and the strong belief of investors and the biopharmaceutical industry in their technology. Levy also indicated that Nanobiotix aims to lead the next generation of nanoparticle-based therapies in healthcare.

NBTXR3 is being tested as a therapeutic that could be integrated into the treatment paradigm for the 60% of cancer patients who receive radiotherapy annually. The current development program focuses on NANORAY-312, an ongoing Phase 3 study for elderly patients with locally advanced head and neck cancer (LA-HNSCC), and a new randomized Phase 2 study for stage 3 non-small cell lung cancer (NSCLC), which Janssen is overseeing.

In preparation for potential regulatory submission, Nanobiotix and Janssen have coordinated the transfer of global sponsorship of the Phase 3 head and neck cancer trial. Nanobiotix will continue to support Janssen in executing the NANORAY-312 trial. They have also agreed to remove the planned futility analysis, deemed unnecessary due to positive data from a related Phase 1 study. Instead, interim data will be analyzed after the last patient is recruited in the first half of 2026.

Louis Kayitalire, Nanobiotix's Chief Medical Officer, expressed confidence in their global licensing agreement with Janssen, emphasizing its potential benefits for patients and healthcare professionals. He highlighted the importance of the Joint Strategy Committee (JSC) in optimizing the success probability for NANORAY-312.

Nanobiotix is exploring options to extend its financial runway beyond the third quarter of 2025. Significant progress has been made in establishing development operations in collaboration with Janssen since their global licensing agreement in July 2023. Key operational milestones include forming a JSC, replicating Nanobiotix's manufacturing processes at Janssen, and achieving a $20 million milestone payment from Janssen.

The collaboration framework between Nanobiotix and Janssen encompasses potential co-development of relevant indications, with Nanobiotix possibly leading new Phase 2 studies for NBTXR3. The JSC will decide on the next indications beyond LA-HNSCC and stage 3 NSCLC. The current pipeline includes studies in various cancer types, such as recurrent or metastatic head and neck cancer, pancreatic cancer, and liver cancer, among others.

Nanobiotix remains committed to validating the safety and efficacy of RT-activated NBTXR3 for LA-HNSCC, which is currently their top priority. The company plans to provide an updated global development plan following alignment with the JSC.

In addition to NBTXR3, Nanobiotix is working on other nanoparticle-based therapy platforms, including Curadigm and OOcuity. Curadigm aims to improve the bioavailability of therapeutics, while OOcuity focuses on influencing neuronal networks to potentially treat neuropathic pain and other conditions.

NBTXR3, composed of functionalized hafnium oxide nanoparticles, is activated by radiotherapy and has shown potential in inducing significant tumor cell death and triggering an adaptive immune response. It has received a European CE mark for soft tissue sarcomas and is evaluated in multiple solid tumor indications, often in combination with anti-PD-1 immune checkpoint inhibitors.

Nanobiotix, incorporated in 2003 and headquartered in Paris, France, has subsidiaries in the United States, Spain, and Germany. The company has been listed on Euronext Paris since 2012 and the Nasdaq Global Select Market since December 2020. With more than 30 patents, Nanobiotix is primarily focused on developing NBTXR3, which has achieved market authorization in Europe for treating soft tissue sarcoma.