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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 08:00

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.

美國費城和加拿大不列顛哥倫比亞,2024年5月30日(GLOBE NEWSWIRE)--BriaCell Therapeutics Corp. (納斯達克: BCTX、BCTXW)(tsx:BCT) (以下簡稱"BriaCell"或"本公司"),一家開發新型免疫治療方案的臨床期生物技術公司,致力於改變癌症治療方式,宣佈啓動一項首次人體研究,評估Bria-OTS的安全性與療效,BriaCell的個性化現成免疫治療方案,作爲單藥治療以及與PD-1 抑制劑tislelizumab聯合治療對於晚期轉移性乳腺癌的療效。

"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."

"作爲我們的第二個新免疫治療方案,推進Bria-OTS進入臨床試驗是BriaCell的一個重要里程碑。我們相信,通過我們的Bria-OTS免疫治療平台進行個性化配置將產生比以前更強效和持久的反應,並有可能與免疫檢查點抑制劑產生協同效應。"BriaCell的總裁兼首席執行官Dr. William V. Williams表示:"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)、臨床試驗中心協議(CTA)和獲得FDA授權的調查新藥(IND)申報市場,以及感謝我們的投資者和合作夥伴支持Bria-OTS更接近癌症患者。"

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Giuseppe Del Priore醫學博士、公共衛生碩士表示:"我們的治療方法適用於現成治療,使患者能夠迅速得到治療,這對於晚期轉移性乳腺癌患者來說具有改變生命的意義。此外,我們期待有關個性化免疫療法Bria-OTS更優越的安全性,將改善生活質量,併爲這些已接受過重度治療的患者增加幾個月甚至幾年的生命,這在晚期癌症治療中是一種獨特的組合優勢。"

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是BriaCell的個性化現成免疫治療平台,是基於Bria-IMT,BriaCell的主導臨床候選人所支持的臨床數據和獲得許多美國和國際專利的基礎上,是BriaCell"OTS"策略的基礎。Bria-OTS用於晚期轉移性乳腺癌是該平台的首次使用。類似的細胞系正在研發中,用於前列腺癌(Bria-PROS+)、肺癌(Bria-LUNG+)和黑色素瘤(Bria-MEL+)

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乳腺癌療法目前正在接受調查新藥申請(IND),也稱爲Bria-BRES。Bria-BRES將發起一個針對其他癌症症狀的桶式試驗(即調查單一研究中的多個產品候選者)。

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

Bria-OTS獲得了國家癌症研究所(NCI)的小型企業創新研究(SBIR)獎勵。更多信息可在

About BriaCell Therapeutics Corp.

關於BriaCell Therapeutics Corp。

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

BriaCell是一家臨床階段的生物技術公司,開發新型免疫療法來改變癌症治療。更多信息可在

Safe Harbor

免責聲明

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"前瞻性聲明",這些聲明受到重大風險和不確定性的影響。本新聞稿中的所有陳述,除去歷史事實陳述之外,都是前瞻性陳述。在本新聞稿中包含的前瞻性聲明可能會通過使用"預計"、"相信"、"思考"、"可能"、"評估"、"期望"、"打算"、"尋求"、"可以"、"計算"、"充分利用"、"承擔"、"可能"、"規劃"、"潛在"、"預測"、"項目"、"目標"、"瞄準"、"應該"、"將"、"願意"或這些語言中的否定互爲替代,以及其他類似性質的表達方式等而進行識別,但是並不是所有的前瞻性聲明都包含這些詞彙。本新聞稿包含前瞻性陳述,包括但不限於BriaCell通過Bria-OTS的個性化配置產生比以前更強效和持久的反應,並有可能與免疫檢查點抑制劑產生協同效應。Bria-OTS的優選安全性會提高重度治療患者的生活質量和壽命,並使Bria-BRES能夠在其他癌症症狀中啓動桶式試驗。這些和其他風險及不確定因素在本公司最新的管理討論和分析中有更詳盡的描述,在本公司最新年度信息摘要的"風險因素"中有更詳盡的描述,在公司的其他文件中在加拿大證券監管機構和美國證券交易委員會進行了描述,所有這些文件都可在SEDAR。+進行查詢,並可在www.sec.gov。本通告中包含的前瞻性陳述是截至本日,BriaCell Therapeutics Corp.除了適用法律法規的規定外,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(根據多倫多證券交易所政策中此項術語的定義)不對本公告的充足性或準確性承擔任何責任。

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:
William V. Williams,MD
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:
Jules Abraham
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


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