TCBP Announces Dosing of 5 New Patients in ACHIEVE
TCBP Announces Dosing of 5 New Patients in ACHIEVE
- 5 New patients dosed, bringing total to 6 patients dosed in ACHIEVE at higher dose level
- 5 Patients received second dose
- 2 Patients received third dose
- 在ACHIEVE項目中,新增5名患者接受了治療,總共有6名患者接受了更高劑量的治療。
- 5名患者接受了第二次的治療。
- 2名患者接受了第三次的治療。
EDINBURGH, Scotland, Sept. 3, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announces dosing of 5 new patients in the ACHIEVE Phase 2b trial ongoing in the UK.
2024年9月3日,蘇格蘭愛丁堡/市場新聞/ -- TC BioPharm (Holdings) PLC(以下簡稱"TC BioPharm"或"公司")(納斯達克: TCBP),一家臨床階段的生物技術公司,正在開發針對癌症和其他適應症的平台異基因γ-δ T細胞療法,今天宣佈在英國ACHIEVE二期試驗中有5名新患者接受了治療。
Currently, the trial has successfully dosed 6 patients with their first of 4 possible doses at the higher dose level. Each 5mL dose contains up to 230 million gamma delta T cells, and a patient is expected to receive up to an approximate 1 billion gamma delta T cells over four doses. Five patients have received their second dose, with 2 of these patients having also received their third dose. This correlates with TCBP's step-wise approach to process improvements, as implemented in Q4 2023, and further steps taken to amend the trial protocol in the first quarter of 2024. New patients will continue to be identified, screened, and enrolled into the study.
目前,該試驗已成功給6名患者注射了他們可能在更高劑量水平上按計劃進行的4次治療中的第一次治療。每5毫升劑量中包含多達2.3億個γ-δ T細胞,一個患者預計在四次治療中將獲得約10億個γ-δ T細胞。其中5名患者已接受了第二次治療,其中2名患者還接受了第三次治療。這與TCBP在2023年第四季度實施的漸進式改進流程和2024年第一季度對試驗方案所做的進一步修改相一致。新患者將繼續被篩選、診斷並納入研究中。
"TCBP is excited to announce our rapid progression in the ACHIEVE Phase 2b trial with very strong enrolment in the second part of the trial using the higher dose," stated, Bryan Kobel, CEO of TC BioPharm. "TCB008 is potentially a game-changing monotherapy for blood cancers, and the strong recruitment and patient retention rates are testament to clinician/physician interest in TCB008 as a monotherapy in leukemia. We're proud of the milestones accomplished to date, having rapidly dosed 6 patients with an additional 10 patients lined up. It is encouraging to see re-dosing of several patients, which we believe reflects positively on the steps the organization took in 2023 and early 2024. TCBP remains poised to execute on our clinical trial plans in 2024 and into 2025, including ACHIEVE and ACHIEVE2, as well as our expanded manufacturing capabilities to enhance our operational capabilities and our economic efficiencies."
TC BioPharm的首席執行官Bryan Kobel表示:"TCBP非常高興宣佈在ACHIEVE二期試驗中的快速進展,高劑量部分取得了非常強勁的入組人數。""TCB008有可能成爲血液癌症的突破性單藥治療方法,臨床醫生/醫師對TCB008作爲白血病單藥治療的興趣以及患者的入組和留組率都是證明。我們爲目前已經取得的里程碑感到驕傲,已經快速給6名患者注射,並計劃繼續治療其他10名患者。多名患者重新接受治療的情況令人鼓舞,我們相信這反映了組織在2023年和2024年初採取的措施的積極作用。TCBioPharm在2024年和2025年將繼續執行我們的臨床試驗計劃,包括ACHIEVE和ACHIEVE2,以及我們擴充的製造能力來增強我們的運營能力和經濟效益。
The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.
ACHIEVE英國臨床試驗是一項開放標籤、二期研究,旨在評估TCB008在AML或MDS/AML患者中的療效和有效性,包括難治性或複發性疾病。
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. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company's intent or ability to affect any budget savings or execute on any M&A or capital raising strategy. These statements are based on management's current assumptions and are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For other important factors that could cause actual results to differ materially from the forward-looking statements in this Current Report on Form 8-K, please see the risks and uncertainties identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and our other reports filed with the SEC, all of which is available on the Company's Investor Relations website at and on the SEC website at www.sec.gov. All forward-looking statements reflect the Company's beliefs and assumptions only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to update forward-looking statements to reflect future events or circumstances.
本新聞稿包含根據1995年《私人證券訴訟改革法案》的前瞻性聲明。在本報告表格8-k中的所有不屬於歷史事實的陳述都應視爲前瞻性聲明,包括但不限於有關公司意圖或能力實現任何預算節約或執行任何併購或籌資策略的聲明。這些陳述基於管理層的當前假設,既不是承諾也不是保證,但涉及已知和未知的風險、不確定性和其他重要因素,可能導致公司的實際結果、表現或成就與任何未來結果、表現或暗示的前瞻性聲明有實質不同。對於其他可能導致實際結果與表格8-k中的前瞻性聲明實質上不同的重要因素,請參閱我們於2023年12月31日年度報告表格10-k中標示的風險和不確定性,以及我們提交給美國證券交易委員會的其他報告,所有這些內容均可在公司的投資者關係網站 和美國證券交易委員會網站 www.sec.gov 上獲得。所有前瞻性聲明僅反映公司在本報告表格8-k發佈日期的信念和假設。公司不承擔更新前瞻性聲明以反映未來事件或情況的義務。
About TC BioPharm (Holdings) PLC
關於TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue.
TC BioPharm是一家臨床階段的生物製藥公司,專注於發現、開發和銷售伽馬-δ t細胞療法治療癌症,具有在急性髓性白血病中的人類功效數據。伽馬-δ T細胞是天然存在的免疫細胞,具有內在區分健康和疾病組織的特性,既體現了先天免疫系統又具備適應性免疫系統的特性。
TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial in treatment of acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.
TC BioPharm是開發伽馬-δ T細胞療法的領導者,也是首家在腫瘤學中開展II期/關鍵性臨床研究的公司。該公司正在爲其未經修改的伽馬-δ T細胞產品系列進行兩項調查員發起的臨床試驗--使用公司專有的異基因冷凍TC技術進行治療的急性髓性白血病的2b/3關鍵性試驗,以爲全球診所提供冷凍產品。
SOURCE TC BioPharm
消息來源:TC BioPharm