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BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS in Advanced Metastatic Breast Cancer

BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS in Advanced Metastatic Breast Cancer

BriaCell 啓動患者入組 Bria-OT 在晚期轉移性乳腺癌中的首次人體研究
GlobeNewswire ·  05/30 20:00

PHILADELPHIA and VANCOUVER, British Columbia, May 30, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS, BriaCell's personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab, in advanced metastatic breast cancer.

費城和不列顛哥倫比亞省溫哥華,2024年5月30日(GLOBE NEWSWIRE)——開發可改變癌症護理的新型免疫療法的臨床階段生物技術公司BriaCell Therapeutics Corp.(納斯達克股票代碼:BCTX,BCTX)(“BriaCell” 或 “公司”)宣佈啓動一項評估Bria-OTS安全性和有效性的首次人體1/2期研究,BriaCell針對晚期轉移性乳腺癌推出的個性化現成下一代免疫療法,包括單一療法,並與PD-1抑制劑替雷利珠單抗聯合使用。

"Advancing Bria-OTS as our second novel immunotherapy candidate into the clinic is a significant milestone for BriaCell. We believe personalization through our Bria-OTS immunotherapy platform will produce more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor," stated Dr. William V. Williams, BriaCell's President & CEO. "We are grateful to our scientific and clinical teams for the successful completion of the Institutional Review Board (IRB), Clinical Trial Site Agreement (CTA), and obtaining FDA authorization for the Investigational New Drug (IND) filings, as well as to our investors and collaborators for their support in bringing Bria-OTS one step closer to cancer patients."

“將Bria-OTS作爲我們的第二種新型免疫療法候選藥物推向臨床是BriaCell的重要里程碑。我們相信,通過我們的Bria-OTS免疫療法平台進行個性化治療將產生比以前觀察到的更有效、更持久的反應,並可能與免疫檢查點抑制劑產生協同作用。” BriaCell總裁兼首席執行官威廉·威廉姆斯博士說。“我們感謝我們的科學和臨床團隊成功完成了機構審查委員會(IRB)、臨床試驗場所協議(CTA),以及獲得美國食品藥品管理局對研究性新藥(IND)申請的授權,也感謝我們的投資者和合作者支持Bria-OTS離癌症患者更近一步。”

Giuseppe Del Priore, MD, MPH, BriaCell's Chief Medical Officer stated, "The off-the-shelf nature of our treatment will allow the patients to be treated rapidly – which can be life changing for advanced metastatic breast cancer patients. Additionally, we expect the preferred safety profile of our personalized immunotherapy, Bria-OTS, to improve the quality of life and add months and even years to the lives of these heavily pretreated patients, a distinctive combination of benefits in late-stage cancer care."

BriaCell首席醫學官朱塞佩·德爾·普里奧雷醫學博士、公共衛生碩士表示:“我們治療的現成性質將使患者能夠得到快速治療——這可能會改變晚期轉移性乳腺癌患者的生活。此外,我們預計,我們的個性化免疫療法Bria-OTS的首選安全特徵將改善生活質量,延長這些經過嚴格預先治療的患者的壽命數月甚至數年,這是晚期癌症治療的獨特優勢組合。”

About Bria-OTS Platform

關於 Bria-OTS 平台

Awarded numerous US and international patents and supported by clinical data of Bria-IMT, BriaCell's lead clinical candidate - currently in a pivotal Phase 3 study for advanced metastatic breast cancer (ClinicalTrials.gov NCT06072612), Bria-OTS is BriaCell's personalized off-the-shelf immunotherapy platform, and the basis for BriaCell's "OTS" strategy. Bria-OTS for advanced metastatic breast cancer is the first use of this platform. Similar cell lines are in development for prostate cancer (Bria-PROS+), lung cancer (Bria-LUNG+), and melanoma (Bria-MEL+).

Bria-OTS獲得了多項美國和國際專利,並得到了BriaCell的主要臨床候選藥物Bria-IMT的臨床數據的支持,Bria-OTS目前處於晚期轉移性乳腺癌的關鍵3期研究(ClinicalTrials.gov NCT06072612),是BriaCell的個性化現成免疫治療平台,也是BriaCell的 “OTS” 戰略的基礎。用於晚期轉移性乳腺癌的Bria-OTS是該平台的首次用途。前列腺癌(Bria-Pros+)、肺癌(Bria-Lung+)和黑色素瘤(Bria-Mel+)的類似細胞系正在開發中。

An Investigational New Drug Application (IND) is currently open for the Bria-OTS breast cancer therapy also known as, Bria-BRES for advanced metastatic breast cancer. Bria-BRES will initiate a bucket trial (i.e. a study that investigates multiple product candidates in a single study) with other cancer indications.

Bria-OTS乳腺癌療法(也稱爲晚期轉移性乳腺癌Bria-BRES)的研究性新藥申請(IND)目前已開放。Bria-BRES將啓動一項包含其他癌症適應症的分桶試驗(即一項在單項研究中調查多個候選產品的研究)。

Bria-OTS received a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI). More information is available at

Bria-OTS獲得了美國國家癌症研究所(NCI)頒發的小企業創新研究(SBIR)獎。更多信息可在以下網址獲得

About BriaCell Therapeutics Corp.

關於 Briacell Therapeutics

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at

BriaCell是一家處於臨床階段的生物技術公司,致力於開發新的免疫療法來改變癌症治療。更多信息可在以下網址獲得

Safe Harbor

安全港

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell's personalization through the Bria-OTS immunotherapy platform producing more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor; the preferred safety profile of Bria-OTS improving the quality of life and increasing the lifespan of heavily pretreated patients; and Bria-BRES initiating a bucket trial with other cancer indications, are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading "Risks and Uncertainties" in the Company's most recent Management's Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under "Risks and Uncertainties" in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

本新聞稿包含受重大風險和不確定性影響的 “前瞻性陳述”。除歷史事實陳述外,本新聞稿中包含的所有陳述均爲前瞻性陳述。本新聞稿中包含的前瞻性陳述可以通過使用 “預測”、“相信”、“考慮”、“可以”、“估計”、“期望”、“打算”、“尋求”、“可能”、“可能”、“潛在”、“預測”、“項目”、“目標”、“應該”、“將”、“會” 或 “將” 等詞語來識別這些詞語或其他類似表述的否定詞,儘管並非所有前瞻性陳述都包含這些詞語。前瞻性陳述,包括關於Bria-OTS免疫療法平台進行個性化設置,其反應比先前觀察到的更有效、更持久,可能與免疫檢查點抑制劑產生協同效應;Bria-OTS的首選安全性特徵改善了經過大量預治療的患者的生活質量並延長了壽命;以及Bria-BRES啓動了針對其他癌症適應症的水桶試驗,都是基於對未來事件的假設,這些假設可能無法證實要準確。在公司最新管理層的討論和分析中,在 “風險和不確定性” 標題下,在公司最新的年度信息表中,在 “風險因素” 標題下,以及公司向加拿大證券監管機構和美國證券交易委員會提交的其他文件中的 “風險和不確定性” 下更全面地描述了這些風險和不確定性,所有這些文件均可在公司在SEDAR+的簡介下查閱,網址和EDGAR上在 www.sec.gov。本公告中包含的前瞻性陳述自該日起作出,除非適用法律要求,否則BriaCell Therapeutics Corp. 沒有義務更新此類信息。

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

多倫多證券交易所及其監管服務提供商(該術語在多倫多證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。

Contact Information

聯繫信息

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com

公司聯繫人:
威廉·威廉姆斯,醫學博士
總裁兼首席執行官
1-888-485-6340
info@briacell.com

Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com

媒體關係:
朱爾斯·亞伯拉罕
CORE IR
julesa@coreir.com

Investor Relations Contact:
CORE IR
investors@briacell.com

投資者關係聯繫人:
CORE IR
investors@briacell.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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