Data show favorable safety and confirm injection feasibility in 12 patients with locally advanced NSCLC amenable to re-irradiation for whom prior lines of therapy have failed

数据显示，在12名局部晚期非小细胞肺癌患者中，这些患者适合再照射治疗且之前的治疗方案已失败，数据表明其安全性良好，并确认了注射的可行性。

A preliminary review of survival data showed 12-month LPFS of 64% (median 18.6 months) and 12-month OS of 83% (median 30.2 months)

初步的生存数据显示，12个月的LPFS为64%（中位数18.6个月），12个月的OS为83%（中位数30.2个月）。

The dose escalation part is complete, and 5/12 patients have been injected to date in the ongoing expansion part

剂量递增部分已经完成，迄今为止，在正在进行的扩展部分中，已有5/12的患者接受了注射。

PARIS and CAMBRIDGE, Mass., March 27, 2025 (GLOBE NEWSWIRE) --

巴黎和马萨诸塞州剑桥，2025年3月27日（环球新闻社）--

NANOBIOTIX

纳米生物技术

(Euronext: NANO –– NASDAQ: NBTX – the ‘‘

（泛欧交易所：NANO - 纳斯达克：NBTX - “

Company

公司

’’), a late-stage clinical biotechnology company pioneering disruptive, nanotherapeutic approaches to revolutionize treatment outcomes for millions of patients, today announced the first data from the completed dose escalation part of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center ('MD Anderson') evaluating radiotherapy-activated NBTXR3 (JNJ-1900).

“）是一家处于后期临床阶段的生物技术公司，致力于开创颠覆性的纳米治疗方法，以彻底改变数百万患者的治疗效果，今天宣布了德克萨斯大学MD安德森癌症中心（'MD安德森'）赞助的第一阶段研究已完成的剂量递增部分的首批数据，该研究评估了放射疗法激活的NBTXR3（JNJ-1900）。”

1

1

as a second or later line (2L+) therapy for patients with locally advanced non-small cell lung cancer (“NSCLC”) amenable to re-irradiation. These data will be presented at the 2025 European Lung Cancer Conference by study principal investigator Dr. Saumil Gandhi.

作为局部晚期非小细胞肺癌（“NSCLC”）患者可进行再照射的二线或后续（2L+）治疗方案。这些数据将由研究主要负责人萨米尔·甘地博士在2025年欧洲肺癌大会上展示。

ABSTRACT #207P: Phase 1 Study of Reirradiation (“ReRT”) with NBTXR3 (JNJ-1900) for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer (“NSCLC”)

摘要 #207P：NBTXR3（JNJ-1900）再照射（“ReRT”）治疗不可手术的局部复发非小细胞肺癌（“NSCLC”）的 I 期研究

Saumil J. Gandhi, MD, PhD, Enoch Chang, MD, Aileen Chen, MD, Stephen G. Chun, MD, Steven H. Lin, MD, PhD, Rachel C. Maguire, BS, Matthew S. Ning, MD, MPH, Julianna K. Bronk, MD, PhD, David Qian, MD, Joe Y. Chang, MD, PhD, James W. Welsh, MD, Zhongxing Liao, MD, Rahul A. Sheth, MD, Roberto F. Casal, MD.

萨米尔·J·甘地（Saumil J. Gandhi），医学博士，哲学博士，恩诺克·张（Enoch Chang），医学博士，艾琳·陈（Aileen Chen），医学博士，史蒂芬·G·春（Stephen G. Chun），医学博士，史蒂文·H·林（Steven H. Lin），医学博士，哲学博士，瑞秋·C·马奎尔（Rachel C. Maguire），理学学士，马修·S·宁（Matthew S. Ning），医学博士，公共卫生硕士，朱莉安娜·K·布朗克（Julianna K. Bronk），医学博士，哲学博士，大卫·钱（David Qian），医学博士，乔·Y·张（Joe Y. Chang），医学博士，哲学博士，詹姆斯·W·威尔士（James W. Welsh），医学博士，廖中兴（Zhongxing Liao），医学博士，拉胡尔·A·谢思（Rahul A. Sheth），医学博士，罗伯托·F·卡萨尔（Roberto F. Casal），医学博士。

Locoregional recurrence occurs in 30-40% of patients with locally advanced NSCLC after treatment with definitive chemoradiation. Historically, patients who are amenable to re-irradiation are often limited to palliative doses due to associated toxicities. As such, strategies to enhance the therapeutic ratio of radiotherapy are needed to improve treatment outcomes..

局部晚期非小细胞肺癌患者在接受根治性放化疗后，30%-40%的患者会出现局部复发。传统上，适合再放疗的患者常因相关毒性而只能接受姑息剂量。因此，需要提升放疗治疗比的策略来改善治疗效果。

“Patients with recurrence after prior radiation therapy for locally advanced lung cancer face limited therapeutic options and significant challenges in achieving durable disease control,”

“在接受过局部晚期肺癌前期放射治疗后复发的患者面临着有限的治疗选择，且在实现持久疾病控制方面具有重大挑战。”

said Saumil Gandhi, MD, PhD, Department of Thoracic Radiation Oncology, Division of Radiation Oncology at MD Anderson.

MD安德森癌症中心胸腔放射肿瘤科、放射肿瘤科的索米尔·甘地（Saumil Gandhi）医学博士、哲学博士表示。

“These data underscore the need for continued therapeutic innovation for these patients and highlight the potential of NBTXR3 (JNJ-1900) as a novel approach to improving patient outcomes.”

“这些数据强调了继续为这些患者进行治疗创新的必要性，并突显了NBTXR3（JNJ-1900）作为改善患者预后的新方法的潜力。”

Results from the completed dose escalation part of the study demonstrated a favorable safety profile with no dose-limiting toxicities (DLTs), and no Grade 3 or higher SAEs related to NBTXR3. Injection feasibility was confirmed, and the recommended phase 2 dose (RP2D) was established at 33% of gross tumor volume..

研究已完成的剂量递增部分结果显示，NBTXR3的安全性良好，未出现剂量限制性毒性（DLTs），且未发生与NBTXR3相关的3级或更高级别的严重不良事件（SAEs）。注射可行性得到确认，并确定了推荐的二期剂量（RP2D）为肿瘤总体积的33%。

Promising early efficacy signals were observed. Preliminary review of survival data from 12 patients showed 12-month LPFS of 64% (median 18.6 months) and 12-month OS of 83% (median 30.2 months), further supporting the potential clinical benefit of NBTXR3 (JNJ-1900) in this patient population.

观察到令人鼓舞的早期疗效信号。对12名患者的生存数据初步审查显示，12个月的LPFS为64%（中位数18.6个月），12个月的OS为83%（中位数30.2个月），进一步支持了NBTXR3（JNJ-1900）在这一患者群体中的潜在临床益处。

“The Nanobiotix team is encouraged by these early findings, which suggest NBTXR3 (JNJ-1900) could offer a new therapeutic option for patients with no alternatives after prior treatments have failed,”

“Nanobiotix团队受到这些早期发现的鼓舞，这些发现表明NBTXR3（JNJ-1900）可能为先前治疗失败后没有其他选择的患者提供一种新的治疗选择。”

said Louis Kayitalire, MD, Nanobiotix Chief Medical Officer.

路易斯·凯塔利尔医学博士，纳米生物技术公司首席医疗官说。

“Notably, these results were observed in patients who resisted prior curative radiation doses and that were treated with JNJ-1900 (NBTXR3) activated by a lower radiation dose. As we advance the study’s expansion phase, we look forward to further evaluating NBTXR3 (JNJ-1900)’s potential to improve patient outcomes.”.

“值得注意的是，这些结果是在对先前治愈性放疗剂量产生抵抗的患者中观察到的，并且这些患者接受了由较低放疗剂量激活的JNJ-1900（NBTXR3）治疗。随着我们推进研究的扩展阶段，我们期待进一步评估NBTXR3（JNJ-1900）改善患者预后的潜力。”

The expansion phase of the study is ongoing, with 5/12 patients injected to date.

研究的扩展阶段正在进行中，迄今为止已有5/12的患者接受了注射。

About JNJ-1900 (NBTXR3)

关于JNJ-1900（NBTXR3）

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.

NBTXR3是一种新型的、潜在的首创新药，由功能化的氧化铪纳米颗粒组成，通过一次性瘤内注射给药，并通过放疗激活。其概念验证已在软组织肉瘤中实现，该产品于2019年获得欧洲CE认证。

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..

该产品候选物的物理作用机制（MoA）旨在通过放射治疗激活时诱导注射肿瘤中显著的肿瘤细胞死亡，随后触发适应性免疫反应和长期抗癌记忆。基于这种物理作用机制，Nanobiotix认为NBTXR3可扩展至任何可通过放射治疗处理的实体瘤及任何治疗组合，特别是免疫检查点抑制剂。

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..

放射治疗激活的NBTXR3正在多个实体瘤适应症中作为单一药物或与抗PD-1免疫检查点抑制剂联合进行评估，包括在NANORAY-312——一项全球性的、随机的三期临床研究中针对局部晚期头颈部鳞状细胞癌。2020年2月，美国食品药品监督管理局（FDA）授予NBTXR3快速通道资格，该药物通过放射治疗激活，可选择是否联合西妥昔单抗，用于治疗无法接受铂类化疗的局部晚期头颈部鳞状细胞癌患者——这一人群与三期研究中评估的人群相同。

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.

鉴于公司的重点领域，并结合NBTXR3的可扩展潜力，Nanobiotix已采取合作策略，在优先开发路径的同时推进该候选产品的开发。根据这一策略，2019年Nanobiotix与德克萨斯大学MD安德森癌症中心达成了广泛而全面的临床研究合作，赞助多项1期和2期研究，评估NBTXR3在多种肿瘤类型和治疗组合中的效果。

In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company..

2023年，Nanobiotix宣布与强生公司旗下的杨森制药签订了一项关于NBTXR3全球共同开发和商业化的许可协议。

About NANOBIOTIX

关于纳米生物技术

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..

Nanobiotix是一家处于后期临床阶段的生物技术公司，致力于开创基于物理的颠覆性治疗方法，以彻底改变数百万患者的治疗效果；其背后是一群致力于为人类做出贡献的人们。公司的理念植根于突破已知界限、拓展人类生命可能性的概念之中。

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公司于2003年成立，总部位于法国巴黎，自2012年起在巴黎泛欧交易所上市，并于2020年12月在纽约纳斯达克全球精选市场上市。该公司在马萨诸塞州剑桥（美国）等地设有子公司。

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.

Nanobiotix 拥有与三个（3）纳米技术平台相关的超过25项伞形专利，这些平台的应用领域包括：1）肿瘤学；2）生物利用度和生物分布；以及3）中枢神经系统疾病。

For more information about Nanobiotix, visit us at

欲了解有关Nanobiotix的更多信息，请访问我们的网站

www.nanobiotix.com

www.nanobiotix.com

or follow us on

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Disclaimer

免责声明

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.

本新闻稿包含1995年《私人证券诉讼改革法》“安全港”条款所指的“前瞻性”声明，包括但不限于关于所得款项用途的声明，以及公司预期其财务资源足以支持运营的时间段。

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.

诸如“预期”、“打算”、“能够”、“可能”、“也许”、“计划”、“潜在”、“应该”和“将”或这些词语的否定形式以及类似的表达旨在识别前瞻性陈述。这些前瞻性陈述基于公司管理层的当前预期和假设，以及管理层目前可获得的信息。

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.

这些前瞻性陈述涉及已知和未知的风险、不确定性以及其他可能导致实际结果与前瞻性陈述所暗示的结果有重大差异的因素，包括与Nanobiotix的业务和财务表现相关的风险，其中包括公司现金流预测所基于的假设未能实现的风险。

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.

有关可能影响公司业务和财务表现的风险因素的更多信息，请参阅Nanobiotix于2024年4月24日向美国证券交易委员会（SEC）提交的20-F表格年度报告中“项目3.D.风险因素”部分，Nanobiotix于2024年4月24日向法国金融市场管理局（AMF）提交的2023年通用注册文件，Nanobiotix于2024年9月18日向SEC提交的6-K表格及向AMF提交的2024年半年度报告中标题为“补充风险因素”的部分，以及Nanobiotix随后不时向SEC提交的文件，这些文件可在SEC网站www.sec.gov上查阅。

The forward-looking statements included in this press release spe.

本新闻稿中包含的前瞻性陈述。

Contacts

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Nanobiotix

纳米生物技术公司

Communications Department

通讯部

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布兰登·欧文斯

VP, Communications

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+1 (617) 852-4835

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contact@nanobiotix.com

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克雷格·韦斯特

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+1 (617) 583-0211

investors@nanobiotix.com

投资者@纳米生物技术.com

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Potential first-in-class radioenhancer “NBTXR3” was licensed to Johnson & Johnson by Nanobiotix in 2023 and renamed “JNJ-1900” for the purposes of Johnson & Johnson-led clinical development.

2023年，Nanobiotix公司将潜在的首创放射增强剂“NBTXR3”授权给强生公司，并更名为“JNJ-1900”，用于强生公司主导的临床开发。

Attachment

附件

2025-03-27 -- NBTX -- 1st Data from Ph1 of NBTXR3 in 2nd Line NSCLC -- FINAL

2025年3月27日 -- NBTX -- NBTXR3在二线非小细胞肺癌1期临床试验的首批数据 -- 最终版