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Actuate Announces Upcoming Presentation on Initial Data on Elraglusib in Combination With FOLFIRINOX at the AACR Special Conference on Advances in Pancreatic Cancer Research

Actuate Announces Upcoming Presentation on Initial Data on Elraglusib in Combination With FOLFIRINOX at the AACR Special Conference on Advances in Pancreatic Cancer Research

Actuate宣佈即將在AACR胰腺癌研究進展特別會議上就Elraglusib與FOLFIRINOX的初步數據進行演示
GlobeNewswire ·  09/16 20:00
  • Preclinical Study Highlight the Potential of Elraglusib in Overcoming FOLFIRINOX-induced Chemoresistance Through Downregulation of Epithelial to Mesenchymal Transition (EMT)
  • Initial Data Demonstrates Early Evidence of Increased Clinical Activity of Combining FOLFIRINOX with Elraglusib and Losartan in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
  • Deep, Durable Responses Observed in 3/6 patients with Extensive Liver Metastases
  • 動物實驗研究突出了Elraglusib在克服FOLFIRINOX誘導的化療耐藥性中的潛力,通過下調上皮間質轉化(EMT)
  • 初步數據證明將FOLFIRINOX與Elraglusib和Losartan聯合使用可增加未經治療的轉移性胰導管腺癌(PDAC)患者的臨床活性
  • 在3/6名有嚴重肝轉移的患者中觀察到深入、持久的療效

CHICAGO and FORT WORTH, Texas, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), announced data from the safety cohort of an ongoing Phase 2 trial of FOLFIRINOX in combination with elraglusib and losartan for untreated metastatic pancreatic adenocarcinoma at the American Association for Cancer Research (AACR) Special Conference on Advances in Pancreatic Cancer Research taking place on September 15-18, 2024, in Boston, Massachusetts.

芝加哥和德克薩斯州沃思堡,2024年9月16日(全球新聞社) - Actuate Therapeutics, Inc.(納斯達克證券交易所代碼:ACTU)(「Actuate」或「公司」)是一家臨床階段的生物製藥公司,專注於開發治療高影響、難以治療癌症的療法,通過抑制糖原合成酶激酶-3β(GSk-3β)獲取結果,宣佈了一項FOLFIRINOX聯合Elraglusib和Losartan治療未經治療的轉移性胰腺腺癌的正在進行中的第2階段試驗的安全隊列數據結果,該結果將在2024年9月15日-18日在馬薩諸塞州波士頓舉行的美國癌症研究協會(AACR)胰腺癌研究進展特別會議上展示。

"We are encouraged by the data presentation at this year's AACR's Special Conference underscoring elraglusib's potential in addressing critical challenges in pancreatic cancer treatment," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "These initial findings provide early clinical evidence that elraglusib may overcome a key chemoresistance mechanism associated with FOLFIRINOX thus enhancing the effectiveness of the combination therapy."

Actuate的總裁兼首席執行官Daniel Schmitt表示:「我們對今年AACR特別會議上展示的數據報告感到鼓舞,突出了Elraglusib在解決胰腺癌治療中的關鍵挑戰方面的潛力。這些初步研究結果提供了早期臨床證據,表明Elraglusib可能克服與FOLFIRINOX相關的一個關鍵化療耐藥機制,從而提高聯合治療的效果。」

The Phase 2 trial (NCT05077800) is an open-label, multi-arm, non-comparator study of FOLFIRINOX in combination with elraglusib and losartan for the treatment of adult patients with untreated metastatic pancreatic adenocarcinoma. The primary objectives of the trial are to determine the safety, tolerability, and progression-free survival of the combination therapy. The trial will enroll up to 70 treatment-naïve metastatic pancreatic adenocarcinoma patients. Actuate Therapeutics supports this trial by supplying the study drug, elraglusib. The Lustgarten Foundation is providing funding support for this study through a research grant.

第2階段試驗(NCT05077800)是一項開放標籤、多臂、非比較試驗,研究FOLFIRINOX聯合Elraglusib和Losartan治療未經治療的轉移性胰腺腺癌的成人患者。該試驗的主要目標是確定聯合治療的安全性、耐受性和無進展生存。該試驗將招募最多70名未經治療的轉移性胰腺腺癌患者。Actuate Therapeutics通過提供研究藥物Elraglusib支持該試驗。Lustgarten基金會通過研究資助爲這項研究提供資金支持。

"We are excited by the promising safety profile and initial evidence of clinical activity demonstrated by the combination of FOLFIRINOX, elraglusib and losartan in this study," said Colin Weekes, MD, Ph.D., Director of Medical Oncology Research for Pancreatic Cancer, Massachusetts General Hospital, and the study's Principal Investigator. "The synergy observed with these drugs suggests that this combination could offer a novel and effective therapeutic strategy for patients with metastatic pancreatic cancer."

馬薩諸塞州綜合醫院胰腺癌醫藥生物技術研究所的臨床腫瘤學研究主任Colin Weekes博士說:「在這項研究中,FOLFIRINOX、埃拉格盧西布和洛沙坦的聯合應用顯示出具有良好安全性和臨床活性的前景,這些藥物的協同作用表明該聯合療法有望爲轉移性胰腺癌患者提供一種新的有效治療策略。」

Poster presentation details Abstract: C073

海報展示的詳情摘要:C073

Title: "FOLFIRINOX with Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor Elraglusib and Transforming Growth Factor- β (TGFβ) Inhibitor Losartan in Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): Interim analysis of safety cohort."
Presenting Author: Priyadarshini Pathak, MD, Medical Oncologist, Massachusetts General Hospital
Session date: Tuesday, September 17, 6:45-9 p.m. ET
Location: Westin Copley Place

標題:「未經治療的轉移性胰腺導管腺癌(PDAC)中的FOLFIRINOX聯合糖原合成酶激酶-3β(GSk-3β)抑制劑埃拉格盧西布和轉化生長因子-β(TGFβ)抑制劑洛沙坦的安全隊列的中期分析。」
主講人:馬薩諸塞州綜合醫院醫學腫瘤學醫生Priyadarshini Pathak博士
會議日期:星期二,9月17日,美國東部時間晚上6:45-9點
地點:Westin Copley Place

The abstract is available online and the poster will be available on Actuate's website after the AACR Meeting.

摘要可在線獲取,並且海報將在 AACR 會議後在 Actuate 的網站上提供。

About Actuate Therapeutics, Inc.

關於Actuate Therapeutics,Inc。

Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate's lead investigational drug product, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy including several DDR pathways. Elraglusib is designed to act as a mediator of anti-tumor immunity through the inhibition of NF-kB and regulates multiple immune checkpoints and immune cell function. For additional information, please visit the Company's website at .

Actuate 是一家專注於開發治療高影響力、難以治療的癌症的臨床階段生物製藥公司。Actuate 的首個研發藥物產品 elraglusib(一種新型 GSk-3β 抑制劑)針對癌症中涉及促進腫瘤生長和抗藥性的分子途徑,包括幾種 DNA 損傷應答 (DDR) 途徑。Elraglusib 被設計爲通過抑制 NF-kb,調節多重免疫檢查點和免疫細胞功能,以充當抗腫瘤免疫的中介物。有關詳情,請訪問該公司網站。

About Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. MGH is a founding member of the Mass General Brigham healthcare system.

關於馬薩諸塞州總醫院
馬薩諸塞州總醫院成立於1811年,是哈佛醫學院的原始和最大的教學醫院。馬總醫院研究所是全美最大的基於醫院的科研機構,年研究運營經費超過10億美元,包括超過9500名研究人員在30多個研究所、中心和部門進行工作。馬總醫院是馬總Brigham醫療體系的創始成員之一。

Forward-Looking Statements

前瞻性聲明

This press release contains forward-looking statements about us, including our clinical trials and development plans, and our industry. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "ongoing," "plan," "potential," "predict," "project," "should," "target," "will," "would," or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, and elraglusib may not achieve favorable results in clinical trials or preclinical studies or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; and our ability to fund development activities. . In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading "Risk Factors" in our final prospectus filed with the SEC on August 13, 2024 pursuant to Rule 424(b)(4) under the Securities Act with respect to our Registration Statement on Form S-1 (File No. 333-279734) and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

本新聞稿包含關於我們的前瞻性聲明,包括我們的臨床試驗和開發計劃以及我們的行業。諸如「預測」、「相信」、「繼續」、「可能」、「估計」、「期望」、「打算」、「可能」、「進行中」、「計劃」、「潛力」、「預測」、「項目」、「應該」、「目標」、「將會」或這些術語的負面形式,或者其他可比較的術語,旨在識別前瞻性聲明,雖然並非所有前瞻性聲明都包含這些識別詞。本新聞稿中除了與目前事實或現狀有關的陳述或歷史事實之外的所有陳述均爲前瞻性聲明。因此,這些陳述涉及估計、假設、重大風險和不確定因素,可能導致其表達的實際結果與其中所表述的結果有實質性差異,包括但不限於:臨床和臨床前藥物開發涉及費時費力、時間不確定以及結果不確定,臨床前研究和早期臨床試驗的結果不一定能預測未來結果,而且Elraglusib可能無法在臨床試驗或臨床前研究中取得有利結果或及時獲得監管批准;我們可能無法成功招募更多患者或制定或推進進一步開發計劃;Elraglusib可能存在副作用、不良事件或其他屬性或安全風險,導致可能延遲或阻止監管批准,導致我們中止或中斷臨床試驗或產生其他負面後果;我們依賴第三方進行非臨床研究和臨床試驗;我們依賴第三方許可人並努力保護和保護我們的知識產權;我們面臨來自其他生物技術和製藥公司的激烈競爭;以及我們資金開發活動的能力。此外,任何前瞻性陳述都完全參照我們在2024年8月13日根據證券法規424(b)(4)根據S-1表(文件編號333-279734)向SEC提交的最終招股說明書中討論的風險因素,以及與SEC一起的其他文件。由於上述風險因素可能導致我們或我們代表我們做出的任何前瞻性陳述的實際結果或結果與其中所表達的結果有實質性差異,您不應過分依賴任何前瞻性陳述。此外,任何前瞻性陳述僅在其發表日期說法。新因素不時出現,我們不能預測哪些因素會出現。此外,我們不能評估每個因素對我們業務的影響,或者任何因素或因素組合對我們實際結果與任何前瞻性陳述所涵蓋的範圍的不同程度造成的影響。除非法律要求,我們不承擔任何義務公開發布對這些前瞻性陳述的修訂,以反映本新聞稿日期後的事件或情況,或者反映不可預料的事件的發生。

Investor Contact

投資者聯繫方式

Mike Moyer

邁克·莫迪爾

Managing Director

董事總經理

LifeSci Advisors, LLC

LifeSci Advisors,LLC

mmoyer@lifesciadvisors.com

mmoyer@lifesciadvisors.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。
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