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NANOBIOTIX Announces Completion of Phase 1 Study of NBTXR3 (JNJ-1900) in Pancreatic Cancer

NANOBIOTIX Announces Completion of Phase 1 Study of NBTXR3 (JNJ-1900) in Pancreatic Cancer

nanobiotix 宣佈完成對胰腺癌NBTXR3 (JNJ-1900)的第一階段研究
GlobeNewswire ·  12/10 05:15
  • Investigators concluded that the encouraging oncologic outcomes coupled with a favorable safety profile warrant further evaluation in a randomized trial
  • 23 months median Overall Survival from date of diagnosis was observed in 22 patients with locally advanced or borderline resectable pancreatic cancer
  • US FDA approved protocol amendment to launch new cohort evaluating RT-activated NBTXR3 combined with standard-of-care concurrent chemotherapy and recruitment is ongoing
  • Full data from the completed dose escalation and dose expansion cohorts to be presented at a medical congress in 1H 2025
  • 調查人員 concluded 令人鼓舞的腫瘤學結果 coupled 與良好的安全性 profile warrant 進一步評估在隨機試驗中
  • 在22名晚期或邊緣可切除胰腺癌患者中觀察到從診斷日期起的23個月中位總生存期
  • 美國FDA批准協議修訂,啓動新的隊列評估Rt-激活的NBTXR3與標準護理的聯合化療,招募正在進行中
  • 完成的劑量遞增和劑量擴展隊列的完整數據將在2025年上半年一個醫療會議上公佈

PARIS and CAMBRIDGE, Mass., Dec. 09, 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 the completion of the dose escalation and dose expansion parts of a Phase 1 study evaluating radiotherapy("RT")-activated NBTXR3 (JNJ-1900) for patients with locally advanced pancreatic cancer ("LAPC") or borderline resectable pancreatic cancer ("BRPC"). The Phase 1 study is being conducted by The University of Texas MD Anderson Cancer Center ("MD Anderson").

巴黎和馬薩諸塞州劍橋,2024年12月09日(全球新聞通訊)-- nanobiotix(Euronext:NANO –– 納斯達克:NBTX – 「公司」),是一家處於晚期臨床階段的生物技術公司,開創了基於納米顆粒的治療方法,以擴展癌症和其他重大疾病患者的治療可能性,今天宣佈已完成評估放射治療("RT")激活的NBTXR3(JNJ-1900)用於局部晚期胰腺癌("LAPC")或邊緣可切除胰腺癌("BRPC")的第一階段研究中的劑量遞增和劑量擴展部分。該第一階段研究由德克薩斯大學安德森癌症中心("MD Anderson")進行。

Patients with LAPC or BRPC often receive initial treatment with cytotoxic chemotherapy followed by RT +/- concurrent or maintenance chemotherapy.

Patients with LAPC or BRPC often receive initial treatment with cytotoxic chemotherapy followed by Rt +/- concurrent or maintenance chemotherapy.

This Phase 1 study was designed to evaluate the safety, feasibility, and early signs of efficacy of RT-activated NBTXR3 for patients with LAPC or BRPC after initial treatment with cytotoxic chemotherapy, in comparison to the historical data in patients who received RT +/- concurrent or maintenance chemotherapy after initial treatment with cytotoxic chemotherapy.

This Phase 1 study was designed to evaluate the safety, feasibility, and early signs of efficacy of Rt-activated NBTXR3 for patients with LAPC or BRPC after initial treatment with cytotoxic chemotherapy, in comparison to the historical data in patients who received Rt +/- concurrent or maintenance chemotherapy after initial treatment with cytotoxic chemotherapy.

Investigators observed an mOS of 23 months from the date of diagnosis in 22 patients (20 with LAPC and 2 with BRPC) on the trial that compared favorably with outcomes at MD Anderson where the historical control for mOS in 144 patients treated at the same center was 19.2 months. Investigators concluded that RT-activated NBTXR3 was well tolerated by all patients and that the encouraging oncologic outcomes observed warrant further evaluation in a randomized trial.

Investigators observed an mOS of 23 months from the date of diagnosis in 22 patients (20 with LAPC and 2 with BRPC) on the trial that compared favorably with outcomes at MD Anderson where the historical control for mOS in 144 patients treated at the same center was 19.2 months. Investigators concluded that Rt-activated NBTXR3 was well tolerated by all patients and that the encouraging oncologic outcomes observed warrant further evaluation in a randomized trial.

Following these encouraging results from the study, MD Anderson submitted and received US FDA clearance for a new, additional study cohort evaluating the combination of NBTXR3 and standard-of-care concurrent chemoradiation. The new cohort has launched, and recruitment is ongoing.

Following these encouraging results from the study, MD Anderson submitted and received US FDA clearance for a new, additional study cohort evaluating the combination of NBTXR3 and standard-of-care concurrent chemoradiation. The new cohort has launched, and recruitment is ongoing.

"The results we have observed in this Phase 1 study give us confidence that NBTXR3 could have a significant impact for these patients," said Louis Kayitalire, MD, Chief Medical Officer at Nanobiotix. "We look forward to the data from the new cohort and believe the combination of NBTXR3 and concurrent chemoradiation could produce even more favorable outcomes for patients with locally advanced or borderline resectable pancreatic cancer."

「我們在這項1期研究中觀察到的結果讓我們相信,NBTXR3可能會對這些患者產生重大影響,」 nanobiotix的首席醫療官Louis Kayitalire博士表示。「我們期待來自新隊列的數據,並相信NBTXR3與同步化療放療的結合可能會爲局部晚期或邊緣可切除的胰腺癌患者帶來更有利的結果。」

Nanobiotix expects full results from the completed dose escalation and dose expansion parts of the study to be presented by MD Anderson at a medical congress in 1H 2025.

nanobiotix預計將由MD安德森在2025年上半年一個醫療會議上發佈該研究的劑量遞增和劑量擴展部分的完整結果。

About NBTXR3

關於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 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.

NBTXR3是一種新型的潛在首個同類腫瘤學產品,由功能化氧化鉿納米顆粒組成,通過一次性腫瘤內注射給藥,並通過放療激活。其概念驗證在軟組織肉瘤中取得,2019年該產品獲得了歐洲CE標誌。該產品候選者的物理作用機制(MoA)旨在通過放療激活,導致注射腫瘤中的腫瘤細胞大量死亡,隨後觸發適應性免疫反應和長期抗癌記憶。鑑於物理作用機制,nanobiotix相信NBTXR3可以在任何可以通過放療治療的實體腫瘤和任何治療組合,特別是免疫檢查點抑制劑中實現可擴展性。

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.

放療激活的NBTXR3正在評估其在多個實體腫瘤指標中作爲單藥治療劑或與抗PD-1免疫檢查點抑制劑聯合使用,包括在NANORAY-312中 - 一項在局部晚期頭頸鱗狀細胞癌中進行全球性、隨機的3期研究。2020年2月,美國食品和藥物管理局授予NBTXR3爲放射治療激活調查的監管快速通道,帶或不帶順鉑,用於治療局部晚期HNSCC的患者 - 與Phase 3研究中評估的人群相同。

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

考慮到公司的重點領域,以及NBTXR3的可擴展潛力,nanobiotix已經實施了一項合作策略,以平行推進產品候選者的開發和優先開發路徑。根據該策略,nanobiotix於2019年與德克薩斯大學MD安德森癌症中心簽訂了一項廣泛的臨床研究合作協議,贊助多個評估NBTXR3在腫瘤類型和治療組合中的I期和II期研究。2023年,nanobiotix宣佈與揚森藥品有限公司簽署全球共同開發和商業化NBTXR3的許可協議。

About NANOBIOTIX

關於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.

Nanobiotix是一家晚期臨床生物技術公司,致力於開拓基於物理學的顛覆性治療方法,爲數以百萬計的患者帶來革命性的治療結果;得到致力於爲人類作出貢獻的人們的支持。該公司的哲學根植於推動超越已知的邊界,擴展人類生命的可能性的概念上。

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.

成立於2003年,Nanobiotix總部位於法國巴黎,在2012年於Euronext Paris上市,並於2020年12月在紐約納斯達克全球精選市場上市。該公司在美國馬薩諸塞州劍橋市等地設有子公司。

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擁有與應用於1)腫瘤學;2)生物可用性和生物分佈性;3)中樞神經系統疾病的3種納米技術平台相關的25個專利申請。

For more information about Nanobiotix, visit us at or follow us on LinkedIn and Twitter

有關nanobiotix的更多信息,請訪問我們的網站或關注我們的領英和推特頁面

Disclaimer

免責聲明

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. 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 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. 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.

本新聞稿包含根據1995年《私人證券訴訟改革法案》的「安全港」條款的「前瞻性」聲明,包括但不限於關於使用其收益及公司預期其財務資源在多長時間內能夠支持業務的聲明。像「預期」、「打算」、「can」、「could」、「may」、「might」、「計劃」、「潛在」、「should」和「will」或其否定形式及類似表達的詞彙旨在識別前瞻性聲明。這些基於公司管理層當前期望和假設以及管理層當前可用的信息的前瞻性聲明涉及已知和未知風險、不確定性以及其他因素,這些因素可能導致實際結果與前瞻性聲明暗示的結果有實質性差異,包括與nanobiotix的業務和財務表現相關的風險,其中包括假設公司的現金週轉預測未能實現的風險。有關可能影響公司業務和財務表現的風險因素的進一步信息已包含在nanobiotix於2024年4月24日向SEC提交的20-F表年度報告中的「第3項D風險因素」,在nanobiotix於2024年4月24日向AMF提交的2023年通用登記文件中,及在nanobiotix於2024年9月18日向SEC提交的6-k表格及向AMF提交的2024年半年度報告中的「補充風險因素」下,以及nanobiotix不時向SEC提交的後續文件,這些文件可在SEC網站www.sec.gov上獲取。本新聞稿中包含的前瞻性聲明僅在本新聞稿發佈之日有效,除法律要求外,nanobiotix不承擔更新這些前瞻性聲明的任何義務。

Contacts

聯繫方式

Nanobiotix
Communications Department
Brandon Owens
VP, Communications
+1 (617) 852-4835
contact@nanobiotix.com
Investor Relations Department
Craig West
SVP, Investor Relations
+1 (617) 583-0211
investors@nanobiotix.com
Media Relations

FR – Ulysse Communication
Laurent Wormser
+ 33 (0)6 13 12 04 04
lwormser@ulysse-communication.com
Global – LifeSci Advisors
Kevin Gardner
+1 (617) 283-2856
kgardner@lifesciadvisors.com
Nanobiotix
通訊部門
Brandon Owens
副總裁,通信
+1 (617) 852-4835
contact@nanobiotix.com
投資者關係部門
Craig West
高級副總裁,投資者關係
+1 (617) 583-0211
investors@nanobiotix.com
媒體關係

FR – Ulysse Communication
Laurent Wormser
+33 (0)6 13 12 04 04
lwormser@ulysse-communication.com
全球貨幣 – LifeSci Advisors
Kevin Gardner
+1 (617) 283-2856
kgardner@lifesciadvisors.com

Attachment

附件

  • 2024-12-09 -- NBTX -- Completes Ph1 NBTXR3 in Pancreatic Cancer -- FINAL
  • 2024-12-09 -- nanobiotix -- 完成NBTXR3在胰腺癌中的第一階段試驗 -- 最終報告

譯文內容由第三人軟體翻譯。


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