<ul>
<li><em>B 组首位患者在第二剂 TCB008 治疗后达成完全缓解</em></li>
</ul>
<p>, /PRNewswire/ -- _TC BioPharm <em>(Holdings)</em> PLC (NASDAQ: TCBP) 是一家临床阶段的生物技术公司，致力于开发用于癌症治疗的伽马δ T 细胞疗法，今天宣布在 B 组接受治疗的首位患者，检测到微小残留病（MRD），在接受主导药物候选 TCB008 治疗后，目前已完全分子缓解。</p>
<p>该患者在治疗开始两周后接受了第二剂 250,000,000 个伽马δ T 细胞，总共在两周内接受了约 500,000,000 个伽马δ T 细胞。该患者接受了可能的 4 次 TCB008 输注中的 2 次，并在 Guy's and St. Thomas' NHS Foundation Trust 的 Hugues de Lavallade 医生的监护下继续接受监测，治疗后两个月仍处于缓解状态。</p>
<p>这一数据发布标志着 TC BioPharm 在开发创新细胞疗法方面的重要里程碑，旨在精准而持久地靶向并消灭恶性细胞。每年全球有超过 100 万患者被诊断为血液癌症。最初实现缓解的患者可能仍然保留分子病负担，导致复发。多种因素，包括以往的治疗，限制了复发患者的治疗选择。</p>
<p>‘这位患者在继续低强度化疗的同时经历了分子复发，’Guy's and St. Thomas' NHS Foundation Trust 的顾问血液学家 Hugues de Lavallade 博士说。‘NPM1 转录本水平在重复样本中检测到上升的 MRD，因此停止了化疗。在淋巴细胞耗竭后给予的两剂 IMP 后，该患者现在已实现完全分子反应，未检测到 NPM1 转录本。’</p>
<p>‘这是一个令人鼓舞的患者反应，我们的团队对这一重要进展感到振奋。我们相信 TCB008 有潜力成为血液癌症患者缓解后治疗的基础组成部分，帮助延长生存期并改善长期结果，同时对新诊断的患者，TCB008 作为单药治疗可能在避免繁重的骨髓移植过程中产生影响，’TC BioPharm 首席执行官 Bryan Kobel 说。‘有效治疗 MRD 可以在疾病有机会复发之前阻止其进展，而 TCB008 的靶向免疫活性在这一背景下继续显示出巨大潜力。对 TCB008 的反应增强了我们对这一患者群体的关注，我们相信伽马δ细胞迅速压倒癌细胞并带来高等级患者反应的能力具有增值和商业影响。’</p>
<p><strong>关于 TC BioPharm (Holdings) PLC</strong> TC BioPharm 是一家临床阶段的生物制药公司，专注于发现、开发和商业化用于癌症治疗的伽马δ T 细胞疗法，并在急性髓性白血病中拥有人体有效性数据。伽马δ T 细胞是自然存在的免疫细胞，具备先天和适应性免疫系统的特性，能够本质上区分健康和病变组织。</p>
<p>TC BioPharm 是开发伽马δ T 细胞疗法的领导者，也是第一家在肿瘤学领域进行 II 期/关键临床研究的公司。该公司正在进行两项研究者发起的临床试验，针对其未修饰的伽马δ T 细胞产品线 - 在急性髓性白血病治疗中进行的 2b/3 期关键试验，使用公司的专有异体 CryoTC 技术向全球诊所提供冷冻产品。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含 1995 年《私人证券诉讼改革法案》意义上的前瞻性声明。本报告中包含的所有不涉及历史事实的声明应视为前瞻性声明，包括但不限于关于公司意图或能力影响任何预算节省或执行任何并购或资本筹集策略的声明。</p>
<p>这些声明基于管理层当前的假设，并非承诺或保证，而是涉及已知和未知的风险、不确定性及其他重要因素，这些因素可能导致公司的实际结果、表现或成就与前瞻性声明中表达或暗示的任何未来结果、表现或成就存在重大差异。有关可能导致实际结果与本报告中前瞻性声明存在重大差异的其他重要因素，请参见我们截至 2023 年 12 月 31 日的年度报告中的 “风险因素” 部分，以及我们向 SEC 提交的其他报告，所有这些报告均可在公司投资者关系网站 www.tcbiopharm.com 和 SEC 网站 www.sec.gov 上获取。所有前瞻性声明仅反映公司在本报告日期的信念和假设。公司没有义务更新前瞻性声明以反映未来事件或情况。</p>
<p>来源 TC BioPharm</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUwNjExJk5ld3NJdGVtSWQ9TlkwNjcwNyZUcmFuc21pc3Npb25fSWQ9MjAyNTA2MTEwODMwUFJfTkVXU19VU1BSX19fX19OWTA2NzA3?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUwNjExJk5ld3NJdGVtSWQ9TlkwNjcwNyZUcmFuc21pc3Npb25fSWQ9MjAyNTA2MTEwODMwUFJfTkVXU19VU1BSX19fX19OWTA2NzA3"/></p>

TCBP

TCBPY

<p>TC BioPharm (Holdings) PLC 宣布，B 组的首位患者在接受第二剂其主要药物候选 TCB008 后，达到了完全分子缓解，且该患者检测到微小残留病（MRD）。该患者在两周内共接受了约 5 亿个伽马δ T 细胞的治疗，并在治疗后两个月仍保持缓解状态。这个里程碑突显了 TCB008 作为血癌患者基础治疗的潜力，旨在改善长期疗效并防止疾病进展</p>

<ul>
<li><em>First patient in Cohort B achieved CR after 2nd dose of TCB008</em></li>
</ul>
<div class="lb-trans"><ul>
<li><em>B 组首位患者在第二剂 TCB008 治疗后达成完全缓解</em></li>
</ul>
</div><p>, /PRNewswire/ -- <em>TC</em> BioPharm <em>(Holdings)</em> PLC (NASDAQ: TCBP), a clinical-stage biotechnology company pioneering gamma delta T cell therapies for the treatment of cancer, today announced the first patient treated in Cohort B, presenting with detectable Minimal Residual Disease (MRD), is now in complete molecular remission following treatment with the lead drug candidate TCB008.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- _TC BioPharm <em>(Holdings)</em> PLC (NASDAQ: TCBP) 是一家临床阶段的生物技术公司，致力于开发用于癌症治疗的伽马δ T 细胞疗法，今天宣布在 B 组接受治疗的首位患者，检测到微小残留病（MRD），在接受主导药物候选 TCB008 治疗后，目前已完全分子缓解。</p>
</div><p>The response was achieved after the patient's second dose of 250,000,000 gamma delta t-cells, two weeks after treatment began, in total the patient received approximately 500,000,000 gamma delta t-cells over two weeks. The patient received 2 of a possible 4 infusions of TCB008 and continues to be monitored under the care of Dr. Hugues de Lavallade at Guy's and St. Thomas' NHS Foundation Trust and remains in remission state two months after treatment.</p>
<div class="lb-trans"><p>该患者在治疗开始两周后接受了第二剂 250,000,000 个伽马δ T 细胞，总共在两周内接受了约 500,000,000 个伽马δ T 细胞。该患者接受了可能的 4 次 TCB008 输注中的 2 次，并在 Guy's and St. Thomas' NHS Foundation Trust 的 Hugues de Lavallade 医生的监护下继续接受监测，治疗后两个月仍处于缓解状态。</p>
</div><p>This data readout represents a major milestone in TC BioPharm's mission to develop innovative cell therapies that target and eradicate malignant cells with precision and durability. Over 1 million patients are diagnosed with blood cancers globally each year. Patients who initially achieve remission can retain a molecular burden of disease that results in relapse. Multiple factors, including previous treatments, limit treatment options for relapsed patients.</p>
<div class="lb-trans"><p>这一数据发布标志着 TC BioPharm 在开发创新细胞疗法方面的重要里程碑，旨在精准而持久地靶向并消灭恶性细胞。每年全球有超过 100 万患者被诊断为血液癌症。最初实现缓解的患者可能仍然保留分子病负担，导致复发。多种因素，包括以往的治疗，限制了复发患者的治疗选择。</p>
</div><p>'This patient experienced molecular relapse while continuing low-intensity chemotherapy,&#34; said Dr. Hugues de Lavallade, consultant hematologist at Guy's and St. Thomas' NHS Foundation Trust. &#34;NPM1 transcript levels detected the rising MRD on repeated samples, and chemotherapy was stopped. After two doses of the IMP, given post-lymphodepletion, the patient has now achieved a complete molecular response with no detectable NPM1 transcripts.&#34;</p>
<div class="lb-trans"><p>‘这位患者在继续低强度化疗的同时经历了分子复发，’Guy's and St. Thomas' NHS Foundation Trust 的顾问血液学家 Hugues de Lavallade 博士说。‘NPM1 转录本水平在重复样本中检测到上升的 MRD，因此停止了化疗。在淋巴细胞耗竭后给予的两剂 IMP 后，该患者现在已实现完全分子反应，未检测到 NPM1 转录本。’</p>
</div><p>&#34;This is an encouraging patient response, and our team is invigorated by this important step forward. We believe TCB008 has the potential to become a foundational component of post-remission therapy for patients with blood cancers, helping to extend survival and improve long-term outcomes, as well as newly diagnosed patients where TCB008 can potentially be impactful as a monotherapy to avoid an arduous bone marrow transplant process&#34; said Bryan Kobel, CEO of TC BioPharm. &#34;Treating MRD effectively halts disease progression before it has the chance to return, and TCB008's targeted immune activity continues to show great promise in this setting. This response to TCB008 heightens our focus on this patient population, where we believe the ability of the gamma deltas to rapidly overwhelm the cancer cells and bring about a high-grade patient response is value-enhancing and commercially impactful.&#34;</p>
<div class="lb-trans"><p>‘这是一个令人鼓舞的患者反应，我们的团队对这一重要进展感到振奋。我们相信 TCB008 有潜力成为血液癌症患者缓解后治疗的基础组成部分，帮助延长生存期并改善长期结果，同时对新诊断的患者，TCB008 作为单药治疗可能在避免繁重的骨髓移植过程中产生影响，’TC BioPharm 首席执行官 Bryan Kobel 说。‘有效治疗 MRD 可以在疾病有机会复发之前阻止其进展，而 TCB008 的靶向免疫活性在这一背景下继续显示出巨大潜力。对 TCB008 的反应增强了我们对这一患者群体的关注，我们相信伽马δ细胞迅速压倒癌细胞并带来高等级患者反应的能力具有增值和商业影响。’</p>
</div><p><strong>About TC BioPharm (Holdings) PLC</strong> TC BioPharm is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gamma-delta T-cell therapies for cancer treatment 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.</p>
<div class="lb-trans"><p><strong>关于 TC BioPharm (Holdings) PLC</strong> TC BioPharm 是一家临床阶段的生物制药公司，专注于发现、开发和商业化用于癌症治疗的伽马δ T 细胞疗法，并在急性髓性白血病中拥有人体有效性数据。伽马δ T 细胞是自然存在的免疫细胞，具备先天和适应性免疫系统的特性，能够本质上区分健康和病变组织。</p>
</div><p>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 the treatment of acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.</p>
<div class="lb-trans"><p>TC BioPharm 是开发伽马δ T 细胞疗法的领导者，也是第一家在肿瘤学领域进行 II 期/关键临床研究的公司。该公司正在进行两项研究者发起的临床试验，针对其未修饰的伽马δ T 细胞产品线 - 在急性髓性白血病治疗中进行的 2b/3 期关键试验，使用公司的专有异体 CryoTC 技术向全球诊所提供冷冻产品。</p>
</div><p><strong>Forward Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>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&amp;A or capital raising strategy.</p>
<div class="lb-trans"><p>本新闻稿包含 1995 年《私人证券诉讼改革法案》意义上的前瞻性声明。本报告中包含的所有不涉及历史事实的声明应视为前瞻性声明，包括但不限于关于公司意图或能力影响任何预算节省或执行任何并购或资本筹集策略的声明。</p>
</div><p>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 &#34;Risk Factors&#34; 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 www.tcbiopharm.com 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.</p>
<div class="lb-trans"><p>这些声明基于管理层当前的假设，并非承诺或保证，而是涉及已知和未知的风险、不确定性及其他重要因素，这些因素可能导致公司的实际结果、表现或成就与前瞻性声明中表达或暗示的任何未来结果、表现或成就存在重大差异。有关可能导致实际结果与本报告中前瞻性声明存在重大差异的其他重要因素，请参见我们截至 2023 年 12 月 31 日的年度报告中的 “风险因素” 部分，以及我们向 SEC 提交的其他报告，所有这些报告均可在公司投资者关系网站 www.tcbiopharm.com 和 SEC 网站 www.sec.gov 上获取。所有前瞻性声明仅反映公司在本报告日期的信念和假设。公司没有义务更新前瞻性声明以反映未来事件或情况。</p>
</div><p>SOURCE TC BioPharm</p>
<div class="lb-trans"><p>来源 TC BioPharm</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUwNjExJk5ld3NJdGVtSWQ9TlkwNjcwNyZUcmFuc21pc3Npb25fSWQ9MjAyNTA2MTEwODMwUFJfTkVXU19VU1BSX19fX19OWTA2NzA3" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=NY06707&amp;Transmission_Id=202506110830PR_NEWS_USPR_____NY06707&amp;DateId=20250611"/></p>

TC Biopharm 宣布微小残留病（MRD）患者获得完全响应