Updated NBTXR3 Global Development Pipeline Visualization (as of May 21, 2024)
*Janssen assumed responsibility for operations in Asia after securing global rights to NBTXR3 in China and Other Asian markets from former Nanobiotix collaborator LianBio. Nanobiotix and Janssen have also aligned to intent to transfer the global sponsorship.
Updated Nanobiotix corporate strategy designed to enable long-term growth through execution of the global NBTXR3 collaboration and platforms beyond NBTXR3
Alignment of intent to transfer the sponsorship of the ongoing Phase 3 pivotal trial in head and neck cancer to begin preparations for potentially positive trial results and subsequent steps
Alignment to Phase 3 head and neck cancer study modifications designed to optimize the regulatory pathway, including intended removal of the now unnecessary futility analysis, and opting to conduct the planned interim analysis after the end of recruitment in 1H2026
Received US FDA "Study May Proceed" letter for a new randomized Phase 2 study evaluating NBTXR3 in stage 3 lung cancer after review of the Investigational New Drug application
Robust pipeline of ongoing and completed studies that could inform development of new indications beyond immediate priorities in head and neck cancer and lung cancer
Operational progress update on Nanobiotix nanoparticle-based therapy platforms beyond NBTXR3 expected in 2H2024
PARIS and CAMBRIDGE, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ''Company''), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced updates to its corporate strategy designed to enable long-term growth in view of significant progress in the Company's collaboration for the co-development and global commercialization of lead therapeutic candidate NBTXR3.
Nanobiotix is developing three nanoparticle-based therapy platforms in sequence. The first therapeutic candidate from the first platform, potential first-in-class radioenhancer NBTXR3, is being developed and potentially commercialized in collaboration with NBTXR3 global licensee Janssen Pharmaceutica NV ("Janssen"), a Johnson & Johnson company. Nanobiotix plans to leverage the sustainable revenue it expects to come from the development and commercialization of NBTXR3 to further advance development of the two other platforms described in the conclusion of this announcement.
"Nanobiotix has long been known for the disruptive potential of NBTXR3 for patients with cancer around the world," said Laurent Levy, chief executive officer at Nanobiotix and chairman of the executive board. "The accomplishments we have achieved throughout our 20-year history stand as a testament to the hard work of our team, the potential value the biopharmaceutical industry at-large sees in our technology, as well as the tremendous faith and confidence our investors and other financiers hold in our vision and our management. Moreover, this global licensing agreement has us well-positioned to secure the path to market for NBTXR3—and our commitment to realize the radioenhancer's medical and economic value remains our most important goal—but the time has also come for Nanobiotix to lead the next generation of nanoparticle-based therapies in healthcare."
Delivering Potentially Curative Outcomes for Patients with Locally Advanced and Metastatic Cancers
NBTXR3 is being evaluated as a therapeutic candidate that could integrate into the cancer treatment paradigm for the 60% of patients with cancer who receive radiotherapy ("RT") as part of their therapeutic regimen each year. To date, NBTXR3 has been injected in hundreds of patients by leading physicians at several pre-eminent clinical research institutions in the United States, Europe, and Asia.
The current NBTXR3 development program is initially focused on the completion of NANORAY-312, an ongoing pivotal phase 3 study evaluating the radioenhancer for elderly patients with locally advanced head and neck cancer ("LA-HNSCC"), and the launch of a randomized Phase 2 study evaluating NBTXR3 for patients with stage 3 non-small cell lung cancer ("NSCLC") for which Janssen is fully responsible.
Preparing NANORAY-312 for Potential Regulatory Submission
In preparation for potential regulatory submission in the event of positive trial results, Nanobiotix and Janssen aligned at the collaboration's Joint Strategy Committee ("JSC") to transfer the global sponsorship of the Phase 3 pivotal head and neck cancer trial. Nanobiotix will continue to support Janssen in execution of NANORAY-312 during and after the sponsorship transfer is complete. Study operations will remain ongoing during the transfer.
Following discussions that began at the end of 2023, and in view of the intended transfer of the sponsorship, the JSC recently aligned to a protocol amendment that would remove the planned futility analysis in light of robust, positive final data from the expansion part of Study 102, a Phase 1 study evaluating NBTXR3 in a similar population. Given that the Study 102 results provided satisfactory support for the NANORAY-312 trial design, the futility analysis was deemed unnecessary. This amendment is subject to review and approval by health authorities in all countries where NANORAY-312 is operational as well as by the sites participating in the study. To date, the amendment has been accepted by health authorities in several major regions in the study.
Additionally, Nanobiotix and Janssen have agreed to a change in approach to the planned interim analysis such that interim data will analyzed and reported after both the requisite number of events have been observed and the last patient has been recruited in 1H2026, rather than immediately after the requisite number of events as originally planned. This revised approach helps to ensure that potentially positive trial results do not influence recruitment prior to completion of the study. As such, Nanobiotix now expects the interim analysis to be reported after the last patient is recruited in 1H2026.
"Bringing a therapeutic candidate from concept to global registration is an exciting, yet daunting proposition for any biotechnology company, even those working within well-known asset classes with well-worn development and regulatory pathways," said Louis Kayitalire, MD, chief medical officer at Nanobiotix. "That is why our global licensing agreement with Janssen is great news for patients, for healthcare professionals, and for all other supporters of NBTXR3's potential. We are confident that the leadership of the JSC will optimize the probability of success for NANORAY-312."
Nanobiotix is currently vetting options for extension of the Company's cash runway beyond the current expectation of 3Q2025.
Advancing the NBTXR3 Collaboration
Nanobiotix and Janssen have made significant progress in establishing development operations in the collaboration since execution of the global licensing agreement in July 2023.
Operational progress highlights:
Established a JSC comprised equally of executives from both companies to drive strategic decision making for the global development program
Activated Joint Working Teams staffed by both companies with an initial focus on manufacturing and preparing NANORAY-312 for global regulatory submission in the event of a positive interim analysis
Began replication of Nanobiotix manufacturing processes to equip Janssen to produce NBTXR3 in parallel with ongoing production activities at Nanobiotix facilities
Began allocation of discretionary in-kind contributions from Janssen to Nanobiotix along with payments for manufacturing technical assistance and other product development support services
Achieved the first operational milestone in NANORAY-312, triggering a $20M milestone payment from Janssen to Nanobiotix
Received US FDA "Study May Proceed" letter for a Janssen-led Phase 2 NSCLC study after review of the Investigational New Drug application
Began elaboration of the overall clinical development plan for NBTXR3 including new indications beyond LA-HNSCC and stage 3 NSCLC
Consolidated global development and commercialization rights with Janssen via the Janssen purchase of rights to China and other Asian Markets from former Nanobiotix partner LianBio
Evolving the NBTXR3 Development Pipeline
The global licensing agreement between Nanobiotix and Janssen established a framework for potential, complementary co-development of relevant indications in the near, medium, and long term. This framework includes the potential for Nanobiotix to lead new randomized Phase 2 NBTXR3 studies. The JSC will ultimately determine the next indications beyond the immediate operational priorities in LA-HNSCC and stage 3 NSCLC. Nanobiotix expects the current pipeline, as detailed below, to play an important role in the JSC decision-making process:
Validating the safety and efficacy of RT-activated NBTXR3 for patients with LA-HNSCC and stage 3 NSCLC in the near-term
Pivotal Phase 3 Study Evaluating RT + NBTXR3 with or without cetuximab for Elderly and Frail Patients with LA-HNSCC who are Ineligible for Cisplatin Chemotherapy (NANORAY-312)
Randomized Phase 2 Study Evaluating NBTXR3 + Chemoradiation + anti-PD-L1 for Patients with Inoperable, Stage 3 NSCLC
Exploring the safety and efficacy of RT-activated NBTXR3 for patients with recurrent or metastatic (R/M) HNSCC that is naïve or resistant to anti-PD-1 in the medium term
Phase 1 Study Evaluating RT + NBTXR3 + Anti-PD-1 for Adult Patients with Recurrent or Metastatic ("R/M") HNSCC Naïve to Anti-PD-1 (Study 1100 Cohort 1)
Phase 1 Study Evaluating RT + NBTXR3 + Anti-PD-1 for Adult Patients with Recurrent or Metastatic R/M HNSCC Resistant to Anti-PD-1 (Study 1100 Cohort 2)
Establishing potential expansion opportunities in additional settings in the medium to long term
Phase 1 Study Evaluating RT + NBTXR3 for Adult Patients with Locally Advanced Pancreatic Cancer
Lead: The University of Texas MD Anderson Cancer Center ("MD Anderson")
Status: Dose escalation part completed and dose expansion part ongoing
Next Step: Presentation of updated data 2H2024
Phase 1 Study Evaluating RT + NBTXR3 for Adult Patients with Inoperable, Recurrent NSCLC Amenable to Re-irradiation
Phase 1 Study Evaluating RT + NBTXR3 + Chemotherapy for Adult Patients with Locally Advanced Esophageal Cancer
Lead: MD Anderson
Status: Dose escalation part ongoing
Next Step: Completion of dose escalation part in 2024, initiation of dose expansion part, and presentation of first data 2025
Phase 1 Study Evaluating RT + NBTXR3 + Anti-PD-1 for Adult Patients with Multiple Advanced Tumors and Metastases Resistant to Anti-PD-1 (Study 1100 Cohort 3)
Phase 1 Study Evaluating RT + NBTXR3 for Adult Patients with Locally Advanced Liver Cancer and/or Liver Metastases
Phase 1 Study Evaluating RT + NBTXR3 + Chemotherapy for Adult Patients with LA-HNSCC
Phase 1 Study Evaluating RT + NBTXR3 + Chemotherapy for Adult Patients with Locally Advanced Rectal Cancer
Validating the safety and efficacy of RT-activated NBTXR3 by moving to global registration in LA-HNSCC remains the immediate priority of Nanobiotix and accounts for the majority of operational and financial resource allocation.
The Company expects to provide an updated global development plan for NBTXR3 after alignment at the JSC.
Updated NBTXR3 Global Development Pipeline Visualization (as of May 21, 2024)
A chart accompanying this announcement is available at
*Janssen assumed responsibility for operations in Asia after securing global rights to NBTXR3 in China and Other Asian markets from former Nanobiotix collaborator LianBio. Nanobiotix and Janssen have also aligned to intent to transfer the global sponsorship.
Nanobiotix Beyond the NBTXR3 Collaboration
As the NBTXR3 program moves toward the ultimate goal of significantly improving outcomes for patients with cancer around the world through the execution of NANORAY-312, Nanobiotix plans to expand the impact of nanoparticle-based therapies in healthcare through continued early-stage development of Curadigm and OOcuity.
The Curadigm "Nanoprimer" platform features nanoparticles designed with specific physico-chemical properties that allow temporary occupation of the liver cells responsible for therapeutic clearance. This mechanism is intended to increase the blood bioavailability and subsequent accumulation of therapeutics in the targeted tissues, potentially providing the opportunity to increase the efficacy or decrease the toxicity of intravenously-administered medicines.
The OOcuity platform is based on the principle that nanoparticle materials can interact with and influence neuronal networks via their electrical properties, this potentially enabling the modulation of malfunctioning neuronal networks toward a "normal" state. In particular, the reduction of neuronal hyper-excitability associated with neuropathic pain in in vitro studies and in mouse models with several nanoparticle candidates.
Nanobiotix expects to provide the next update on the plan and operational progress of programs beyond NBTXR3 in 2H2024.
About 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. The product candidate's physics-based 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 physics-based 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.
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 III 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.
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. In 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company.
更新了 NBTXR3 全球開發管道可視化（截至 2024 年 5 月 21 日）
*在從前 Nanobiotix 合作者聯拓生物手中獲得 NBTXR3 在中國和其他亞洲市場的全球版權後，詹森承擔了在亞洲的運營責任。Nanobiotix和Janssen也已達成一致，打算轉移全球贊助。
更新的 Nanobiotix 企業戰略旨在通過執行 NBTXR3 以外的全球 NBTXR3 合作和平台來實現長期增長
意向一致，將正在進行的頭頸癌3期關鍵試驗的贊助權轉移到開始爲可能的陽性試驗結果和後續步驟做準備
與旨在優化監管途徑的 3 期頭頸部癌症研究修改保持一致，包括計劃刪除現在不必要的徒勞分析，以及選擇在 1H2026 招募結束後進行計劃中的中期分析
在對研究性新藥申請進行審查後，收到美國食品藥品管理局關於一項評估 NBTXR3 處於第 3 階段肺癌的新隨機 2 期研究的 “研究可能繼續” 信函
大量正在進行和已完成的研究，這些研究可以爲頭頸癌和肺癌的當務之急之外的新適應症的開發提供信息
NBTXR3 以外的基於 Nanobiotix 納米顆粒的治療平台預計將在 2H2024 中更新運營進展
巴黎和馬薩諸塞州劍橋，2024年5月21日（GLOBE NEWSWIRE）——NANOBIOTIX（泛歐交易所：NANO —— 納斯達克股票代碼：NBTX — “公司”）是一家處於臨床後期階段的生物技術公司，開創了基於納米顆粒的治療方法，以擴大癌症和其他主要疾病患者的治療可能性，今天宣佈更新其公司戰略，旨在實現長期增長，因爲該公司合作在共同開發方面取得了重大進展以及主要候選療法 NBTXR3 的全球商業化。
Nanobiotix正在按順序開發三種基於納米顆粒的治療平台。第一個平台的首個候選療法，即潛在的同類首創放射增強劑 NBTXR3，正在與強生公司 NBTXR3 全球被許可方詹森製藥公司（“Janssen”）合作開發，並有可能實現商業化。Nanobiotix 計劃利用其預期從 NBTXR3 的開發和商業化中獲得的可持續收入，進一步推進本公告結論中描述的另外兩個平台的開發。
Nanobiotix首席執行官兼執行委員會主席洛朗·利維說：“長期以來，Nanobiotix以 NBTXR3 對全球癌症患者具有顛覆性潛力而聞名。”“我們在20年的歷史中取得的成就證明了我們團隊的辛勤工作，整個生物製藥行業對我們技術的潛在價值，以及我們的投資者和其他金融家對我們的願景和管理的巨大信心和信心。此外，這項全球許可協議使我們處於有利地位，可以確保NBTXR3的市場化道路——我們實現放射增強劑的醫療和經濟價值的承諾仍然是我們最重要的目標——但Nanobiotix引領下一代基於納米顆粒的醫療保健療法的時機也已到來。”
爲局部晚期癌症和轉移性癌症患者提供潛在的治療結果
對於每年接受放射治療（“RT”）作爲治療方案一部分的 60% 的癌症患者，NBTXR3 正在被評估爲一種可納入癌症治療模式的候選治療方案。迄今爲止，美國、歐洲和亞洲幾家卓越臨床研究機構的頂尖醫生已向數百名患者注射 NBTXR3。
當前的 NBTXR3 開發計劃最初側重於完成 NANORAY-312，這是一項正在進行的評估局部晚期頭頸癌（“LA-HNSCC”）老年患者的放射增強劑（“LA-HNSCC”）的關鍵性三期研究，以及啓動一項評估詹森全權負責的第 3 期非小細胞肺癌（“NSCLC”）患者的 NBTXR3 的隨機二期研究。
爲 NANORAY-312 爲可能的監管機構申報做準備
在試驗結果呈陽性的情況下，Nanobiotix和Janssen在合作的聯合戰略委員會（“JSC”）上達成了協議，以轉移對3期關鍵頭頸癌試驗的全球贊助，爲可能的監管機構提交申請做準備。在贊助轉讓完成期間和之後，Nanobiotix 將繼續支持詹森執行 NANORAY-312。在移交期間，研究工作將繼續進行。
在 2023 年底開始的討論之後，鑑於贊助權的意向轉移，JSC 最近同意了一項協議修正案，該修正案將根據第 102 號研究（一項評估類似人群中 NBTXR3 的第 1 階段研究）擴展部分的可靠積極的最終數據，取消計劃中的徒勞性分析。鑑於第 102 項研究的結果爲 NANORAY-312 試驗設計提供了令人滿意的支持，因此認爲沒有必要進行徒勞分析。該修正案須經所有實施 NANORAY-312 的國家衛生當局以及參與研究的場所的審查和批准。迄今爲止，該修正案已被研究中幾個主要地區的衛生當局接受。
此外，Nanobiotix和Janssen已同意改變計劃中期分析的方法，以便在觀察到必要數量的事件並在 1H2026 招募了最後一名患者之後，而不是按原計劃在必要數量的事件之後立即分析和報告中期數據。這種修訂後的方法有助於確保潛在的陽性試驗結果不會影響研究完成前的招聘。因此，Nanobiotix現在預計，中期分析將在招募最後一名患者加入 1H2026 後公佈。
Nanobiotix首席醫學官Louis Kayitalire醫學博士表示：“對於任何生物技術公司來說，將候選療法從概念轉向全球註冊都是一個令人興奮但又艱鉅的主張，即使是那些在知名資產類別中從事開發和監管途徑的公司也是如此。“這就是爲什麼我們與詹森的全球許可協議對患者、醫療保健專業人員以及 NBTXR3 潛力的所有其他支持者來說都是個好消息。我們相信，股份公司的領導層將優化 NANORAY-312 的成功概率。”
Nanobiotix目前正在審查延長公司現金流的備選方案，以超出目前對 3Q2025 的預期。
推進 NBTXR3 合作
自2023年7月執行全球許可協議以來，Nanobiotix和Janssen在建立合作開發業務方面取得了重大進展。
運營進展要點：
成立了一個由兩家公司的高管均等組成的股份公司，以推動全球發展計劃的戰略決策
啓動了由兩家公司組成的聯合工作組，最初的重點是製造 NANORAY-312，並在中期分析得出積極的情況下爲全球監管機構申報做好準備
開始複製 Nanobiotix 的製造工藝，使詹森能夠生產 NBTXR3，同時在 Nanobiotix 工廠進行持續的生產活動
開始向Nanobiotix分配詹森的全權實物捐助，並支付製造技術援助和其他產品開發支持服務的費用
在 NANORAY-312 中實現了第一個運營里程碑，觸發了 Janssen 向 Nanobiotix 支付 2000 萬美元的里程碑式付款
在對研究性新藥申請進行審查後，收到美國食品藥品管理局關於詹森領導的非小細胞肺癌2期研究的 “研究可能繼續” 信函
開始制定 NBTXR3 的總體臨床開發計劃，包括 LA-HNSCC 和 3 期 NSCLC 以外的新適應症
通過詹森從Nanobiotix前合作伙伴LianBiotix手中收購中國和其他亞洲市場的版權，鞏固了與詹森的全球開發和商業化權利
發展 NBTXR3 開發管道
Nanobiotix和Janssen之間的全球許可協議爲近期、中期和長期相關適應症的潛在互補性共同開發建立了框架。該框架包括 Nanobiotix 領導新的隨機第 2 期 NBTXR3 研究的可能性。除了LA-HNSCC和第三階段NSCLC的當務之急外，JSC最終將確定下一步的適應症。Nanobiotix預計，目前的管道將在JSC的決策過程中發揮重要作用，如下所述：
驗證 RT 激活的 NBTXR3 在短期內對 LA-HNSCC 和 3 期 NSCLC 患者的安全性和有效性
探索 RT 激活的 NBTXR3 在中期內對複發性或轉移 (R/M) HNSCC 患者的安全性和有效性
從中長期來看，在其他環境中建立潛在的擴張機會
評估局部晚期胰腺癌成人患者的 RT + NBTXR3 的 1 期研究
評估無法手術、複發性非小細胞肺癌可接受再照射的成年患者的 RT + NBTXR3 的 1 期研究
負責人：MD 安德森
狀態：劑量遞增部分已完成，劑量擴展部分正在進行中
下一步：顯示第一個數據 1H2025
評估局部晚期食管癌成人患者的 RT + NBTXR3 + 化療的 1 期研究
評估對抗PD-1具有耐藥性的多種晚期腫瘤和轉移瘤的成年患者使用RT + NBTXR3 + 抗PD-1的1期研究（研究1100 隊列3）
評估局部晚期肝癌和/或肝轉移成年患者的 RT + NBTXR3 的 1 期研究
主管：Nanobiotix
狀態：第 1 階段已完成，主要終點已滿足
下一步：中長期進一步發展的潛在新跡象
評估 LA-HNSCC 成年患者的 RT + NBTXR3 + 化療的 1 期研究
狀態：已完成，主要終點已滿足
下一步：中長期進一步發展的潛在新跡象
評估局部晚期直腸癌成人患者的 RT + NBTXR3 + 化療的 1 期研究
狀態：第 1 階段已完成，主要終點已滿足
下一步：中長期進一步發展的潛在新跡象
通過在LA-HNSCC進行全球註冊來驗證RT激活的 NBTXR3 的安全性和有效性仍然是Nanobiotix的當務之急，佔運營和財務資源分配的大部分。
在與股份公司協調後，該公司預計將爲 NBTXR3 提供最新的全球發展計劃。
更新了 NBTXR3 全球開發管道可視化（截至 2024 年 5 月 21 日）
本公告附帶的圖表可在以下網址獲取
*在從前 Nanobiotix 合作者聯拓生物手中獲得 NBTXR3 在中國和其他亞洲市場的全球版權後，詹森承擔了在亞洲的運營責任。Nanobiotix和Janssen也已達成一致，打算轉移全球贊助。
Nanobiotix 超越 NBTXR3 合作
隨着 NBTXR3 計劃朝着通過執行 NANORAY-312 顯著改善全球癌症患者預後的最終目標邁進，Nanobiotix計劃通過持續的早期開發Curadigm和Oocuity來擴大基於納米顆粒的療法在醫療保健中的影響力。
Curadigm “Nanoprimer” 平台採用具有特定物理化學特性的納米顆粒，允許臨時佔用負責治療清除的肝細胞。該機制旨在增加血液生物利用度以及隨後治療在靶組織中的積累，從而有可能爲提高靜脈注射藥物的療效或降低其毒性提供機會。
OOCuity平台基於這樣的原理，即納米顆粒材料可以通過其電氣特性與神經元網絡相互作用並影響神經元網絡，這有可能使出現故障的神經元網絡調製到 “正常” 狀態。特別是，在體外研究和使用幾種納米顆粒候選物的小鼠模型中，與神經病理性疼痛相關的神經元過度興奮性降低。
Nanobiotix預計將在 2H2024 中提供有關 NBTXR3 以外項目的計劃和運營進展的下一次最新情況。
關於 NBTXR3
NBTXR3 是一種新型的、可能是同類首創的腫瘤學產品，由功能化的氧化氦納米顆粒組成，通過一次性腫瘤內注射給藥，並通過放射療法激活。其概念驗證是在軟組織肉瘤中實現的，該產品於2019年獲得了歐洲CE標誌。該候選產品的基於物理學的作用機制（MoA）旨在通過放療激活後，在注射的腫瘤中誘發嚴重的腫瘤細胞死亡，從而觸發適應性免疫反應和長期抗癌記憶。鑑於基於物理學的 MoA，Nanobiotix 認爲，NBTXR3 可以擴展到任何可通過放射療法治療的實體瘤和任何治療組合，尤其是免疫檢查點抑制劑。
正在評估放射療法激活的 NBTXR3 作爲單一藥物或與抗 PD-1 免疫檢查點抑制劑聯合應用的多種實體瘤適應症，包括 nanoray-312，這是一項針對局部晚期頭頸部鱗狀細胞癌的全球隨機 III 期研究。2020 年 2 月，美國食品藥品監督管理局批准了監管機構的 Fast Track 資格，以研究通過放射療法激活的 NBTXR3，無論是否使用西妥昔單抗，用於治療沒有資格接受鉑類化療的局部晚期 HNSCC 患者，第 3 期研究正在評估同一人群。
鑑於公司的重點領域，並平衡了 NBTXR3 的可擴展潛力，Nanobiotix 制定了一項合作戰略，以擴大候選產品的開發，同時擴大其優先開發路徑。根據這一戰略，Nanobiotix於2019年與德克薩斯大學醫學博士安德森癌症中心建立了廣泛而全面的臨床研究合作，贊助了幾項評估腫瘤類型和治療組合的 NBTXR3 的1期和2期研究。2023 年，Nanobiotix 宣佈與強生旗下公司 Janssen Pharmaceutica NV 簽訂許可協議，在 NBTXR3 的全球共同開發和商業化。
