share_log

Aura Biosciences Announces Additional Data From Ongoing Phase 1 Trial in Non-Muscle Invasive Bladder Cancer to Be Presented as a Late-Breaking Abstract at the 40th Annual European Association of Urology Congress

Aura Biosciences Announces Additional Data From Ongoing Phase 1 Trial in Non-Muscle Invasive Bladder Cancer to Be Presented as a Late-Breaking Abstract at the 40th Annual European Association of Urology Congress

Aura Biosciences宣佈在第40屆歐洲泌尿科協會年會上將呈現非肌肉侵犯膀胱癌正在進行的第一階段試驗的更多數據作爲晚間發佈摘要。
GlobeNewswire ·  03/03 12:00

Aura will Participate in the Research Forum at the 40th Annual European Association of Urology Congress

Aura將參加第40屆歐洲泌尿學協會年會的研究論壇

Aura will Host a Virtual Urologic Oncology Investor Event Featuring Key Opinion Leaders at 4:30 pm Eastern Time on March 24, 2025

Aura將在2025年3月24日下午4:30(東部時間)舉辦虛擬泌尿腫瘤投資者活動,邀請重要意見領袖參與

BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced that additional Phase 1 data evaluating bel-sar (AU-011) for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) will be presented at the 40th Annual European Association of Urology (EAU) Congress being held March 21-24, 2025, in Madrid, Spain. Aura will also participate in the EAU Research Forum during the Congress.

波士頓,2025年3月3日(環球新聞通訊社) -- Aura生物科學公司(納斯達克:AURA),是一家開發精準治療固體腫瘤的臨牀階段生物技術公司,旨在保護器官功能,今日宣佈將在2025年3月21日至24日在西班牙馬德里舉行的第40屆歐洲泌尿學協會(EAU)年會上,展示評估bel-sar(AU-011)用於治療非肌肉浸潤性膀胱癌(NMIBC)患者的額外第一階段數據。Aura還將在會議期間參加EAU研究論壇。

The EAU late-breaker presentation details are as follows:

EAU延期報告的詳細信息如下:

Title: Safety and efficacy of Bel-sar (AU-011), a Virus-like-Drug-Conjugate (VDC), in patients with Non-Muscle Invasive Bladder Cancer (NMIBC)

標題:Bel-sar(AU-011)的安全性和有效性, 一種病毒樣藥物結合物(VDC), 用於非肌肉侵襲性膀胱癌(NMIBC)患者

Presenter:

演講者:

  • Seth Lerner, MD, Scott Department of Urology, Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA
  • Seth Lerner, 醫學博士, 斯科特泌尿外科, 丹·L·鄧肯綜合癌症中心, 貝勒醫學院, 休斯頓, TX, 美國

Date/Time: Saturday, March 22, 2025, from 3:30 pm to 3:35 pm Central European Standard Time (10:30 am to 10:45 am Eastern Time)

日期/時間:2025年3月22日(星期六)下午3:30至3:35 中歐標準時間(東部時間上午10:30至10:45)

The EAU Research Forum details are as follows:

EAU研究論壇的詳細信息如下:

Title: Virus-like Drug Conjugates (VDC), a paradigm shifting approach for the treatment of bladder cancer: Mechanism, First Insights, and Future Directions

標題:病毒樣藥物結合物(VDC),一種改變膀胱癌治療的範式轉變方法:機制、初步見解與未來方向

Presenters and Moderator:

演講者和主持人:

  • Shahrokh F. Shariat, MD, Dept. of Urology, Medical University of Vienna, Vienna, Austria
  • Laura Bukavina, MD, Glickman Urological Institute Cleveland Clinic Cleveland, OH, USA
  • Peter Black, MD, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada
  • Sabine D. Brookman-May, MD, Aura Biosciences, Boston, MA, USA; Dept. of Urology, University of Munich, LMU, Munich, Germany
  • Shahrokh F. Shariat,醫學博士,維也納醫科大學泌尿外科,奧地利維也納
  • Laura Bukavina,醫學博士,克利夫蘭診所Glickman泌尿外科研究所,美國俄亥俄州克利夫蘭
  • Peter Black,醫學博士,不列顛哥倫比亞大學泌尿科學系,加拿大溫哥華
  • Sabine D. Brookman-May, 醫學博士,Aura Biosciences,波士頓,馬薩諸塞州,美國;慕尼黑大學泌尿科,慕尼黑,德國

Date/Time: Sunday, March 23, 2025, from 12:30 pm to 12:45 pm Central European Standard Time (7:30 am to 7:45 am Eastern Time)

日期/時間:2025年3月23日星期日,中央歐洲標準時間下午12:30至12:45(東部時間上午7:30至7:45)

The presentations will be available here, following the live presentations.

演示文稿將在此處可用,緊隨現場演示之後。

Virtual urologic oncology investor event on Monday, March 24, 2025, at 4:30 pm Eastern Time

2025年3月24日星期一,東部時間下午4:30舉行虛擬泌尿腫瘤投資者活動

Aura will host a virtual urologic oncology investor event featuring Neal Shore, MD, FACS (Carolina Urologic Research Center), Gary Steinberg, MD, FACS (Rush University) and Jennifer A. Linehan, MD (Saint John's Cancer Institute), who will join company management to discuss additional data from the ongoing Phase 1 trial in NMIBC, a multi-center, open-label clinical trial designed as a window of opportunity study to assess the safety and feasibility of local administration of bel-sar as a monotherapy prior to transurethral resection of bladder tumor (TURBT), the standard of care procedure. The study is designed to evaluate different approaches to optimize the feasibility of local administration and includes histopathological evaluation after a single dose to assess bel-sar's biological activity and dual mechanism of action including the characterization of the immune response.

Aura將舉辦一場虛擬泌尿腫瘤投資者活動,邀請Neal Shore, 醫學博士,FACS(卡羅萊納泌尿學研究中心),Gary Steinberg, 醫學博士,FACS(拉什大學)和Jennifer A. Linehan, 醫學博士(聖約翰抗癌研究所)與公司管理層一起討論來自NMIBC的正在進行的1期試驗的更多數據。本試驗爲多中心、開放標籤的臨牀試驗,旨在作爲機會窗口研究,以評估在膀胱腫瘤經尿道切除術(TURBT)前局部施用bel-sar作爲單藥治療的安全性和可行性,這一程序是標準護理。該研究旨在評估優化局部施用可行性的不同方法,包含在單劑量後進行組織病理學評估,以評估bel-sar的生物活性和雙重作用機制,包括免疫反應的特徵。

At the event, Aura will also provide a bladder cancer program update, including the planned Phase 1b/2 trial expansion and future development plans. A live question and answer session will follow the discussion. To register for the event, click here.

在活動中,Aura還將提供膀胱癌項目的最新信息,包括計劃的1b/2期試驗擴展和未來的發展計劃。討論後將進行現場問答環節。要註冊該活動,請點擊此處。

The live webcast of Aura's virtual urologic oncology investor event will be available on the "Investors & Media" page under the "Events & Presentations" section of Aura's website at , where a replay of the webcast will be archived for 90 days following the presentation date.

Aura虛擬泌尿腫瘤投資者活動的現場直播將在Aura網站的「投資者與媒體」頁面下的「活動與演示」部分提供,演示日期後將存檔此網絡研討會重播90天。

About Neal Shore, MD, FACS

關於Neal Shore博士, FACS

Neal Shore, MD, FACS graduated from Duke University and Duke University Medical School. He completed his general surgery/urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Ketering Cancer Center. He serves as the Medical Director for the Carolina Urologic Research Center. Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, the APCCC Scientific Steering Committee, Maple Tree Cancer Alliance, Alessa Therapeutics, Photocure, and the Duke Global Health Institute. He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy, and the co-chair of the annual AUA International Prostate Forum. He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP and World Journal of Urology. He is the Editor of Reviews in Urology and serves as an Editor of Everyday Urology-Oncology. He is a Fellow of the American College of Surgeons.

Neal Shore博士,FACS畢業於杜克大學和杜克大學醫學院。他在紐約醫院-康奈爾醫療中心/紀念斯隆-凱特琳癌症中心完成了普通外科/泌尿科住院醫師培訓。 他擔任卡羅來納泌尿研究中心的醫學主任。Shore博士進行了超過400項臨牀試驗,主要關注泌尿生殖腫瘤,並發表了超過350篇同行評審的學術論文和多篇書籍章節。他是抗癌醫藥(SITC)膀胱癌指南委員會成員,以及膀胱癌倡導網絡,APCCC科學指導委員會,楓樹癌症聯盟,Alessa治療公司,Photocure和杜克全球健康研究所的董事會成員。他分別擔任前列腺癌Academy和膀胱/腎癌Academy的主席,並擔任年度AUA國際前列腺論壇的聯合主席。他曾擔任/目前擔任《泌尿學評論》,《泌尿學時間》,《化療顧問》,《OncLive》,《PLOS ONE》,《泌尿學實踐》,《JUOP》和《世界泌尿學雜誌》的編輯委員會成員。他是《泌尿學評論》的主編,並擔任《日常泌尿-腫瘤學》的編輯。他是美國外科醫師學會的博士會士。

About Gary Steinberg, MD, FACS

關於加里·施泰因伯格,醫學博士,FACS

Gary Steinberg, MD, FACS received his medical degree from the University of Chicago Pritzker School of Medicine and completed urology residency and urologic oncology fellowship at The Brady Urological Institute- Johns Hopkins University. He is a professor in the Department of Urology at Rush University in Chicago. Dr. Steinberg is a national authority in the surgical treatment of bladder cancer and continent urinary tract reconstruction and is a recognized expert in translational bladder cancer research as well as innovative clinical trials. A prolific researcher, Dr. Steinberg has made significant contributions to our understanding of both non-muscle invasive and invasive bladder cancer and serves as the principal investigator on numerous clinical trials, working to identify new novel therapies as well as molecular biomarkers to detect the disease. Dr. Steinberg has authored or coauthored more than 200 articles as well as nearly two dozen chapters for medical textbooks. Currently, he serves on the editorial board of multiple urologic oncology journals and is the immediate past chairperson of the scientific advisory board of the Bladder Cancer Advocacy Network.

加里·施泰因伯格,醫學博士,FACS 從芝加哥大學普利茲克醫學院獲得醫學學位,並在約翰霍普金斯大學布雷迪泌尿科研究所完成泌尿科住院醫生培訓和泌尿腫瘤學專科培訓。他是芝加哥拉什大學泌尿科的教授。施泰因伯格博士是膀胱癌外科治療與大陸尿路重建的國家權威,同時也是轉化膀胱癌研究和創新臨牀試驗的公認專家。作爲一名多產的研究者,施泰因伯格博士對非肌肉侵襲性和侵襲性膀胱癌的理解做出了重要貢獻,並作爲多項臨牀試驗的首席研究員,努力識別新的新型療法以及用於檢測疾病的分子生物標誌物。施泰因伯格博士已撰寫或合著了200多篇文章,以及近兩打醫學教科書章節。目前,他擔任多個泌尿腫瘤學期刊的編輯委員會成員,並且是膀胱癌倡導網絡科學顧問委員會的前任主席。

About Jennifer A. Linehan, MD

關於詹妮弗·A·萊尼漢,醫學博士

Jennifer Linehan is a board-certified urologist and associate professor of urology and urologic oncology at Saint John's Cancer Institute. She specializes in general urology and urologic oncology, with expertise in robotic and laparoscopic surgery, as well as cancer research. Dr. Linehan earned her medical degree from the University of Arizona, where she also completed her general surgery internship and urology residency. She has received multiple awards for compassionate care and research in kidney cancer. Dedicated to personalized patient care, Dr. Linehan works with multidisciplinary teams to provide innovative and comprehensive treatment. She is certified by the American Board of Urology and actively contributes to research and education.

詹妮弗·萊尼漢是一位獲得認證的泌尿科醫生,現任聖約翰癌症研究所泌尿科及泌尿腫瘤學的副教授。她專注於普通泌尿科和泌尿腫瘤學,精通機器人及腹腔鏡手術以及癌症研究。萊尼漢博士在亞利桑那大學獲得醫學學位,並在該校完成了普通外科實習和泌尿科住院醫生培訓。她因對腎癌的同情關懷和研究獲得了多項獎勵。致力於個性化患者護理,萊尼漢博士與多學科團隊合作,提供創新和全面的治療。她獲得了美國泌尿科委員會的認證,並積極參與研究和教育工作。

About Aura Biosciences

關於Aura生物科學

Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients. For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Aura生物科學是一家臨牀階段的生物技術公司,專注於爲固體腫瘤開發精準療法,旨在保護器官功能。我們的主要候選藥物bel-sar(AU-011)目前正在針對原發性脈絡膜黑色素瘤進行晚期開發,並在其他眼腫瘤指徵和膀胱癌中處於早期開發階段。Aura生物科學總部位於馬薩諸塞州波士頓。我們的使命是作爲一家創新的全球腫瘤公司不斷成長,積極改變患者的生活。欲了解更多信息,請訪問aurabiosciences.com。請在X(前Twitter)上關注我們 @AuraBiosciences,並在領英上訪問我們。

Forward-Looking Statements

前瞻性聲明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "may," "will," "could," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include express or implied statements regarding Aura's future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of bel-sar for the treatment of cancers including bladder cancer; statements regarding Aura's plans and expectations for its ongoing and future clinical trials of bel-sar in bladder cancer; statements regarding the timing and plans to present data with respect to its Phase 1 clinical trial of bel-sar for the treatment of bladder cancer, as well as a bladder cancer program update, including the planned Phase 1b/2 trial expansion and future development plans; statements regarding the timing and content of the EAU late breaker presentation, EAU Research Forum, and Aura's virtual urologic oncology investor event; statements regarding Aura's expectations for an improved quality of life of patients after treatment with bel-sar and changes to the treatment paradigm for patients; statements regarding Aura's expectations for the estimated patient populations and related market opportunities for bel-sar; and statements regarding the timing of the announcement of additional NMIBC data from Aura's ongoing Phase 1 trial of bel-sar, as well as a bladder cancer program update, including the planned Phase 1b/2 trial expansion and future development plans.

本新聞稿包含根據1995年《私人證券訴訟改革法案》(及其修正案)和其他聯邦證券法的定義的前瞻性聲明。任何不是歷史事實的陳述可能被視爲前瞻性聲明。諸如「可能」、「將」、「可以」、「應該」、「期望」、「打算」、「計劃」、「預期」、「相信」、「估計」、「預測」、「項目」、「尋求」、「努力」、「潛在」、「繼續」或這些詞的否定形式或其他類似表達方式可用於識別前瞻性聲明。這些前瞻性聲明包括關於Aura未來期望、計劃和前景的明確或隱含聲明,包括但不限於,關於bel-sar在治療包括膀胱癌在內的癌症方面的治療潛力的聲明;關於Aura針對bel-sar在膀胱癌中正在進行和未來臨牀試驗的計劃和期望的聲明;關於bel-sar針對膀胱癌治療的第1階段臨牀試驗的數據呈現時機和計劃的聲明,以及包括計劃中的第1b/2階段試驗擴大和未來開發計劃的膀胱癌項目更新;關於EAU晚間突發報告、EAU研究論壇和Aura的虛擬泌尿腫瘤投資者活動的時間和內容的聲明;關於Aura期望bel-sar治療後患者的生活質量改善和對患者治療模式變化的聲明;關於Aura對bel-sar估計患者群體和相關市場機會的期望的聲明;以及關於Aura正在進行的bel-sar第1階段試驗的額外NMIBC數據公佈時機和膀胱癌項目更新的聲明,包括計劃中的第1b/2階段試驗擴大及未來開發計劃。

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Aura's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura's preclinical and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that early, additional or interim data from ongoing clinical trials may not be predictive of final data from completed clinical trials; the risk that governmental authorities may disagree with Aura's clinical trial designs, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 special protocol assessment agreement with the U.S. Food and Drug Administration; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Aura's ongoing and planned preclinical activities; and Aura's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties and other factors include those risks and uncertainties described under the heading "Risk Factors" in Aura's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura's current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

本新聞稿中的前瞻性聲明既不是承諾也不是保證,投資者不應過度依賴這些前瞻性聲明,因爲它們涉及已知和未知的風險、不確定性和其他因素,其中許多超出了Aura的控制範圍,並可能導致實際結果與這些前瞻性聲明中表達或暗示的結果存在重大差異,包括,但不限於,臨牀試驗中固有的不確定性以及來自正在進行的臨牀試驗的數據可用性和時機;政府機構對監管批准或審查提交的預期時機;Aura的臨牀前和臨牀試驗結果可能無法預測未來臨牀試驗結果的風險;來自正在進行的臨牀試驗的早期、額外或中期數據可能無法預測已完成的臨牀試驗的最終數據的風險;即使Aura已獲得政府機構在這些試驗設計上達成一致,政府機構可能仍不同意Aura的臨牀試驗設計的風險,例如與美國食品藥品監督管理局的第3階段特殊方案評估協議;Aura是否將獲得進行試驗或市場產品的監管批准;Aura的現金資源是否足以滿足其可預見和不可預見的營業費用及資本支出需求;Aura正在進行和計劃的臨牀前活動;以及Aura啓動、招募、進行或完成正在進行和計劃的臨牀試驗的能力。這些風險、不確定性和其他因素包括在Aura最近提交的年度報告10-K表格和季度報告10-Q表格中列出的「風險因素」標題下描述的風險和不確定性,這些報告已提交至美國證券交易委員會(SEC),並且在Aura與SEC後續提交的文件中可獲得,這些文件可在SEC網站www.sec.gov上找到。除法律要求外,Aura對本新聞稿中包含的任何前瞻性聲明在新信息、未來發展或以其他方式情況下更新或修訂的意圖或責任予以否認。這些前瞻性聲明基於Aura當前的期望,僅在此日期有效,未對任何此類前瞻性聲明的準確性作出任何明確或隱含的表述或保證。

Investor and Media Contact:

投資者及媒體聯繫:

Alex Dasalla
Head of Investor Relations and Corporate Communications
IR@aurabiosciences.com

亞歷克斯·達薩拉
投資者關係和企業通信負責人
IR@aurabiosciences.com


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
評論 評論 · 瀏覽 396

熱點推薦

搶先評論

聲明

本頁的譯文內容由軟件翻譯。富途將竭力但卻不能保證翻譯內容之準確和可靠,亦不會承擔因任何不準確或遺漏而引起的任何損失或損害。