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项目中,新增5名患者接受了治疗,总共有6名患者接受了更高剂量的治疗。
- 5名患者接受了第二次的治疗。
- 2名患者接受了第三次的治疗。
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,苏格兰爱丁堡/市场新闻/ -- TC BioPharm (Holdings) PLC(以下简称"TC BioPharm"或"公司")(纳斯达克: TCBP),一家临床阶段的生物技术公司,正在开发针对癌症和其他适应症的平台异基因γ-δ T细胞疗法,今天宣布在英国ACHIEVE二期试验中有5名新患者接受了治疗。
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,该试验已成功给6名患者注射了他们可能在更高剂量水平上按计划进行的4次治疗中的第一次治疗。每5毫升剂量中包含多达2.3亿个γ-δ T细胞,一个患者预计在四次治疗中将获得约10亿个γ-δ T细胞。其中5名患者已接受了第二次治疗,其中2名患者还接受了第三次治疗。这与TCBP在2023年第四季度实施的渐进式改进流程和2024年第一季度对试验方案所做的进一步修改相一致。新患者将继续被筛选、诊断并纳入研究中。
"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的首席执行官Bryan Kobel表示:"TCBP非常高兴宣布在ACHIEVE二期试验中的快速进展,高剂量部分取得了非常强劲的入组人数。""TCB008有可能成为血液癌症的突破性单药治疗方法,临床医生/医师对TCB008作为白血病单药治疗的兴趣以及患者的入组和留组率都是证明。我们为目前已经取得的里程碑感到骄傲,已经快速给6名患者注射,并计划继续治疗其他10名患者。多名患者重新接受治疗的情况令人鼓舞,我们相信这反映了组织在2023年和2024年初采取的措施的积极作用。TCBioPharm在2024年和2025年将继续执行我们的临床试验计划,包括ACHIEVE和ACHIEVE2,以及我们扩充的制造能力来增强我们的运营能力和经济效益。
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英国临床试验是一项开放标签、二期研究,旨在评估TCB008在AML或MDS/AML患者中的疗效和有效性,包括难治性或复发性疾病。
Forward-Looking Statements
前瞻性声明
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.
本新闻稿包含根据1995年《私人证券诉讼改革法案》的前瞻性声明。在本报告表格8-k中的所有不属于历史事实的陈述都应视为前瞻性声明,包括但不限于有关公司意图或能力实现任何预算节约或执行任何并购或筹资策略的声明。这些陈述基于管理层的当前假设,既不是承诺也不是保证,但涉及已知和未知的风险、不确定性和其他重要因素,可能导致公司的实际结果、表现或成就与任何未来结果、表现或暗示的前瞻性声明有实质不同。对于其他可能导致实际结果与表格8-k中的前瞻性声明实质上不同的重要因素,请参阅我们于2023年12月31日年度报告表格10-k中标示的风险和不确定性,以及我们提交给美国证券交易委员会的其他报告,所有这些内容均可在公司的投资者关系网站 和美国证券交易委员会网站 www.sec.gov 上获得。所有前瞻性声明仅反映公司在本报告表格8-k发布日期的信念和假设。公司不承担更新前瞻性声明以反映未来事件或情况的义务。
About TC BioPharm (Holdings) PLC
关于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是一家临床阶段的生物制药公司,专注于发现、开发和销售伽马-δ t细胞疗法治疗癌症,具有在急性髓性白血病中的人类功效数据。伽马-δ T细胞是天然存在的免疫细胞,具有内在区分健康和疾病组织的特性,既体现了先天免疫系统又具备适应性免疫系统的特性。
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是开发伽马-δ T细胞疗法的领导者,也是首家在肿瘤学中开展II期/关键性临床研究的公司。该公司正在为其未经修改的伽马-δ T细胞产品系列进行两项调查员发起的临床试验--使用公司专有的异基因冷冻TC技术进行治疗的急性髓性白血病的2b/3关键性试验,以为全球诊所提供冷冻产品。
SOURCE TC BioPharm
消息来源:TC BioPharm