<p>/PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) 和 Quantum Leap Healthcare Collaborative（&#34;Quantum Leap&#34;）今天宣布了一项新的合作，旨在评估 TransCode 的主要治疗候选药物 TTX-MC138，作为 Quantum Leap PRE-I-SPY 临床试验平台的一部分。</p>
<p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2583692/TransCode_Logo.jpg?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://mma.prnewswire.com/media/2583692/TransCode_Logo.jpg"/></p>
<p>PRE-I-SPY 项目将把 TTX-MC138 纳入一项 II 期剂量扩展临床试验，招募多达 45 名已完成标准治愈性治疗且 ctDNA 阳性的结直肠癌患者。该 II 期部分的试验计划于 2026 年上半年开始，由 MD Anderson Cancer Center 的首席研究员 Paula Pohlmann 博士领导。</p>
<p>本临床试验旨在评估 TTX-MC138 在最小残留病（MRD）环境中的生物学和临床活性，在该环境中，治疗干预可能有最大的机会改善长期结果。选择在经过标准治疗后表现出病理完全缓解但有循环肿瘤 DNA（ctDNA）证据的患者中测试 TTX-MC138，是基于这些患者的高复发率和该环境中缺乏有效治疗的考虑。TTX-MC138 在该环境中提供了一种治疗选择，因为该药物的作用机制专门针对转移性疾病，并具有出色的安全性。</p>
<p>&#34;在 TransCode 的 I 期临床试验中观察到的 TTX-MC138 的安全性和持久的临床益处为 TransCode 决定继续进行 II 期临床测试提供了基础，&#34; TransCode 的顾问临床医生 Daniel Vlock 医生指出。&#34;观察到的安全性特征，加上 TTX-MC138 的抗肿瘤效果的持久性，特别令人鼓舞。这些发现与该药物的作用机制一致，并为更严格的疗效评估提供了基础。这使我们能够在患者疾病的早期进行干预，为有发展转移性疾病风险的患者提供新的治疗选择。&#34;</p>
<p>&#34;在癌症中，检测和治疗微转移性疾病在其变得可见之前，是最大的未满足挑战之一，&#34; Quantum Leap 的联合创始人、加州大学旧金山分校外科和放射学教授 Laura Esserman 医生表示。&#34;PRE-ISPY 试验独特地定位于快速评估可能消除最小残留病并防止结直肠癌及最终其他癌症复发的药物，如 TTX-MC138。我们很高兴与 TransCode 合作，加速该项目，目标是将有效、低毒性的精准治疗推进到 II 期及更高阶段——在这里，真正治愈患者的潜力存在。&#34;</p>
<p><strong>关于 TTX-MC138</strong></p>
<p>TTX-MC138 是一种首创的治疗候选药物，旨在抑制微小 RNA-10b，或称 miR-10b，这是一种被广泛认为对许多转移性癌症的出现和进展至关重要的微小 RNA。TransCode 的 I 期首次人体临床试验达到了主要安全性终点，并建立了推荐的 II 期剂量，如在 ESMO 2025 上所宣布的。</p>
<p><strong>关于 TransCode Therapeutics</strong></p>
<p>TransCode Therapeutics 是一家临床阶段公司，开创了高风险和晚期癌症的免疫肿瘤学和 RNA 治疗。该公司的主要治疗候选药物 TTX-MC138 专注于治疗过表达微小 RNA-10b 的转移性肿瘤，这是一种独特且经过充分记录的转移生物标志物。此外，TransCode 还拥有其他首创治疗候选药物的组合，旨在动员免疫系统识别和摧毁癌细胞。有关更多信息，请访问 www.transcodetherapeutics.com。</p>
<p><strong>关于 I-SPY 试验</strong></p>
<p>I-SPY（&#34;Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis&#34;）试验旨在快速筛选有前景的实验性治疗，并识别对生物学上定义的患者亚组最有效的治疗。这些试验代表了美国食品和药物管理局、行业合作伙伴、患者倡导者、慈善赞助商和美国领先癌症研究中心临床医生之间的独特合作。Quantum Leap Healthcare Collaborative 是试验赞助商，负责所有运营、监管和数据整合活动。PRE-ISPY 平台将 I-SPY 扩展到早期可行性测试，以加速生物靶向疗法进入 I-SPY 2.2 高风险治愈环境。有关更多信息，请访问 <strong>www.ispytrials.org</strong>。</p>
<p><strong>关于 Quantum Leap Healthcare Collaborative</strong></p>
<p>Quantum Leap Healthcare Collaborative 是一家于 2005 年由 UCSF 研究人员和硅谷创新者创立的 501(c)(3) 非营利组织。其使命是将临床护理与研究相结合，推进高影响力的平台试验，并通过自适应学习系统、增强的数据基础设施和广泛的试验可及性改善患者结果。Quantum Leap 赞助和管理 I-SPY 试验项目。有关更多信息，请访问 <strong>www.quantumleaphealth.org</strong>。</p>
<p><strong>前瞻性声明</strong></p>
<p>本公告包含 1995 年《私人证券诉讼改革法案》所定义的 “前瞻性声明”，包括但不限于关于 TransCode 与 Quantum Leap 的合作时间、过程和结果的声明，TransCode 的 1a 期临床试验，TransCode 计划的 2a 期临床试验，以及将 TTX-MC138 纳入 PRE-I-SPY 项目进行 2a 期剂量扩展临床试验的声明，关于微小 RNA 及其在癌症中的作用的声明，以及关于 TransCode 的 TTX-MC138 和其他治疗候选药物的治疗潜力的声明。本新闻稿中的任何前瞻性声明均基于管理层对未来事件的当前预期，并受到多种风险和不确定性的影响，这些风险和不确定性可能导致实际结果与这些前瞻性声明中所列或暗示的结果存在重大不利差异。这些风险和不确定性包括但不限于：与药物发现和开发相关的风险；临床试验结果可能与 TransCode 的临床前研究或预期结果或之前临床试验的结果不一致的风险；与临床试验的进行相关的风险；与 TransCode 的财务状况及其需要获得额外资金以支持其业务活动相关的风险，包括 TransCode 继续作为持续经营的能力；与 TransCode 计划的监管提交的时间和结果相关的风险；与获得、维护和保护知识产权相关的风险；与 TransCode 对侵权者执行其专利和捍卫其专利组合免受第三方挑战的能力相关的风险；来自其他开发类似用途产品公司的竞争风险；与 TransCode 对第三方的依赖相关的风险；以及与地缘政治事件和疫情相关的风险，包括 COVID-19 冠状病毒和军事行动。有关这些及其他风险和不确定性的讨论，以及可能导致 TransCode 的实际结果与前瞻性声明中所包含或暗示的结果不同的其他重要因素，请参见 TransCode 截至 2024 年 12 月 31 日的 10-K 表格年度报告中的 “风险因素” 部分，以及 TransCode 向证券交易委员会提交的任何后续文件中对潜在风险、不确定性和其他重要因素的讨论。本新闻稿中的所有信息均截至发布之日；TransCode 不承担更新此信息的义务，除非法律要求。</p>
<p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2843185/Quantum_Leap_Healthcare_Collaborative.jpg?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://mma.prnewswire.com/media/2843185/Quantum_Leap_Healthcare_Collaborative.jpg"/></p>
<p>来源：TransCode Therapeutics, Inc.</p>

RNAZ

<p>TransCode Therapeutics 和 Quantum Leap Healthcare Collaborative 宣布将进行 TTX-MC138 的第二阶段扩展剂量试验，此前 TransCode 的第一阶段试验结果积极。该试验将招募多达 45 名 ctDNA 阳性的结直肠癌患者，旨在评估 TTX-MC138 在最小残留疾病环境中的生物学和临床活性。试验预计将在 2026 年上半年开始，由 MD Anderson Cancer Center 的 Paula Pohlmann 博士主导</p>

<p>, /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative (&#34;Quantum Leap&#34;) today announce a new collaboration to evaluate TransCode's lead therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform.</p>
<div class="lb-trans"><p>/PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) 和 Quantum Leap Healthcare Collaborative（&#34;Quantum Leap&#34;）今天宣布了一项新的合作，旨在评估 TransCode 的主要治疗候选药物 TTX-MC138，作为 Quantum Leap PRE-I-SPY 临床试验平台的一部分。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2583692/TransCode_Logo.jpg" alt="" original-src="https://mma.prnewswire.com/media/2583692/TransCode_Logo.jpg"/></p>
<p>The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion clinical trial enrolling up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and are ctDNA positive. The Phase 2a portion of the trial is planned to begin in the first half of 2026 and will be led by Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center.</p>
<div class="lb-trans"><p>PRE-I-SPY 项目将把 TTX-MC138 纳入一项 II 期剂量扩展临床试验，招募多达 45 名已完成标准治愈性治疗且 ctDNA 阳性的结直肠癌患者。该 II 期部分的试验计划于 2026 年上半年开始，由 MD Anderson Cancer Center 的首席研究员 Paula Pohlmann 博士领导。</p>
</div><p>This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the Minimal Residual Disease (MRD) setting, where the therapeutic intervention may have the greatest opportunity to improve long-term outcomes. The decision to test TTX-MC138 in patients who have demonstrated a pathological complete response following standard-of-care therapy but have evidence of circulating tumor DNA (ctDNA) is based on the high degree of recurrence in those patients and the lack of effective therapies in that setting. TTX-MC138 offers a therapeutic option in that setting because of the drug's mechanism of action specifically targeting metastatic disease combined with an excellent safety profile.</p>
<div class="lb-trans"><p>本临床试验旨在评估 TTX-MC138 在最小残留病（MRD）环境中的生物学和临床活性，在该环境中，治疗干预可能有最大的机会改善长期结果。选择在经过标准治疗后表现出病理完全缓解但有循环肿瘤 DNA（ctDNA）证据的患者中测试 TTX-MC138，是基于这些患者的高复发率和该环境中缺乏有效治疗的考虑。TTX-MC138 在该环境中提供了一种治疗选择，因为该药物的作用机制专门针对转移性疾病，并具有出色的安全性。</p>
</div><p>&#34;The safety and durable clinical benefit observed in TransCode's Phase 1a trial with TTX-MC138 provide the basis for TransCode's decision to proceed with Phase 2a clinical testing&#34;, noted Daniel Vlock, MD, TransCode's Consulting Clinician. &#34;The observed safety profile, coupled with the durability of TTX-MC138's anti-tumor effects, is particularly encouraging. These findings are consistent with the drug's mechanism of action and provide a basis for a more rigorous efficacy evaluation. This positions us to potentially intervene earlier in the patient's disease, offering a new therapeutic option for patients at risk of developing metastatic disease.&#34;</p>
<div class="lb-trans"><p>&#34;在 TransCode 的 I 期临床试验中观察到的 TTX-MC138 的安全性和持久的临床益处为 TransCode 决定继续进行 II 期临床测试提供了基础，&#34; TransCode 的顾问临床医生 Daniel Vlock 医生指出。&#34;观察到的安全性特征，加上 TTX-MC138 的抗肿瘤效果的持久性，特别令人鼓舞。这些发现与该药物的作用机制一致，并为更严格的疗效评估提供了基础。这使我们能够在患者疾病的早期进行干预，为有发展转移性疾病风险的患者提供新的治疗选择。&#34;</p>
</div><p>&#34;Detecting and treating micrometastatic disease before it becomes visible is one of the biggest unmet challenges in cancer,&#34; said Laura Esserman, M.D., co-founder of Quantum Leap, and Professor of Surgery and Radiology at the University of California, San Francisco. &#34;The PRE-ISPY Trial is uniquely positioned to rapidly evaluate agents like TTX-MC138 that may eradicate minimal residual disease and prevent recurrence in colorectal and eventually other cancer. We are excited to collaborate with TransCode to accelerate this program, with the goal of advancing effective, less toxic precision therapies into Phase 2 and beyond—where the potential to truly cure patients exists.&#34;</p>
<div class="lb-trans"><p>&#34;在癌症中，检测和治疗微转移性疾病在其变得可见之前，是最大的未满足挑战之一，&#34; Quantum Leap 的联合创始人、加州大学旧金山分校外科和放射学教授 Laura Esserman 医生表示。&#34;PRE-ISPY 试验独特地定位于快速评估可能消除最小残留病并防止结直肠癌及最终其他癌症复发的药物，如 TTX-MC138。我们很高兴与 TransCode 合作，加速该项目，目标是将有效、低毒性的精准治疗推进到 II 期及更高阶段——在这里，真正治愈患者的潜力存在。&#34;</p>
</div><p><strong>About TTX-MC138</strong></p>
<div class="lb-trans"><p><strong>关于 TTX-MC138</strong></p>
</div><p>TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode's Phase 1a first-in-human clinical trial achieved its primary safety endpoint and established a recommended Phase 2 dose, as announced at ESMO 2025.</p>
<div class="lb-trans"><p>TTX-MC138 是一种首创的治疗候选药物，旨在抑制微小 RNA-10b，或称 miR-10b，这是一种被广泛认为对许多转移性癌症的出现和进展至关重要的微小 RNA。TransCode 的 I 期首次人体临床试验达到了主要安全性终点，并建立了推荐的 II 期剂量，如在 ESMO 2025 上所宣布的。</p>
</div><p><strong>About TransCode Therapeutics</strong></p>
<div class="lb-trans"><p><strong>关于 TransCode Therapeutics</strong></p>
</div><p>TransCode Therapeutics is a clinical stage company pioneering immunoncology and RNA therapeutic treatments of high risk and advanced cancers. The company's lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In addition, TransCode has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. For more information, visit www.transcodetherapeutics.com.</p>
<div class="lb-trans"><p>TransCode Therapeutics 是一家临床阶段公司，开创了高风险和晚期癌症的免疫肿瘤学和 RNA 治疗。该公司的主要治疗候选药物 TTX-MC138 专注于治疗过表达微小 RNA-10b 的转移性肿瘤，这是一种独特且经过充分记录的转移生物标志物。此外，TransCode 还拥有其他首创治疗候选药物的组合，旨在动员免疫系统识别和摧毁癌细胞。有关更多信息，请访问 www.transcodetherapeutics.com。</p>
</div><p><strong>About the I-SPY TRIALs</strong></p>
<div class="lb-trans"><p><strong>关于 I-SPY 试验</strong></p>
</div><p>The I-SPY (&#34;Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis&#34;) Trials were designed to rapidly screen promising experimental treatments and identify those most effective for biologically defined patient subgroups. The trials represent a unique collaboration among the U.S. Food and Drug Administration, industry partners, patient advocates, philanthropic sponsors, and clinicians across leading U.S. cancer research centers. Quantum Leap Healthcare Collaborative is the trial sponsor and oversees all operational, regulatory, and data-integration activities. The PRE-ISPY platform extends I-SPY into early feasibility testing to accelerate biologically targeted therapies into the I-SPY 2.2 high-risk curative setting. For more information, visit <strong>www.ispytrials.org</strong>.</p>
<div class="lb-trans"><p>I-SPY（&#34;Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis&#34;）试验旨在快速筛选有前景的实验性治疗，并识别对生物学上定义的患者亚组最有效的治疗。这些试验代表了美国食品和药物管理局、行业合作伙伴、患者倡导者、慈善赞助商和美国领先癌症研究中心临床医生之间的独特合作。Quantum Leap Healthcare Collaborative 是试验赞助商，负责所有运营、监管和数据整合活动。PRE-ISPY 平台将 I-SPY 扩展到早期可行性测试，以加速生物靶向疗法进入 I-SPY 2.2 高风险治愈环境。有关更多信息，请访问 <strong>www.ispytrials.org</strong>。</p>
</div><p><strong>About Quantum Leap Healthcare Collaborative</strong></p>
<div class="lb-trans"><p><strong>关于 Quantum Leap Healthcare Collaborative</strong></p>
</div><p>Quantum Leap Healthcare Collaborative is a 501(c)(3) nonprofit organization founded in 2005 by UCSF researchers and Silicon Valley innovators. Its mission is to integrate clinical care with research, advance high-impact platform trials, and improve patient outcomes through adaptive learning systems, enhanced data infrastructure, and widespread trial accessibility. Quantum Leap sponsors and manages the I-SPY Trial programs. For additional information, visit <strong>www.quantumleaphealth.org</strong>.</p>
<div class="lb-trans"><p>Quantum Leap Healthcare Collaborative 是一家于 2005 年由 UCSF 研究人员和硅谷创新者创立的 501(c)(3) 非营利组织。其使命是将临床护理与研究相结合，推进高影响力的平台试验，并通过自适应学习系统、增强的数据基础设施和广泛的试验可及性改善患者结果。Quantum Leap 赞助和管理 I-SPY 试验项目。有关更多信息，请访问 <strong>www.quantumleaphealth.org</strong>。</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 release contains &#34;forward-looking statements&#34; within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the timing, conduct and results of TransCode's collaborations with Quantum Leap, TransCode's Phase 1a clinical trial, TransCode's planned Phase 2a clinical trial, and the incorporation of TTX-MC138 into the PRE-I-SPY program for a Phase 2a dose-expansion clinical trial, statements about microRNAs and their involvement in cancer, and statements concerning the therapeutic potential of TransCode's TTX-MC138 and other therapeutic candidates. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risks associated with drug discovery and development; the risk that the results of clinical trials will not be consistent with TransCode's preclinical studies or expectations or with results from previous clinical trials; risks associated with the conduct of clinical trials; risks associated with TransCode's financial condition and its need to obtain additional funding to support its business activities, including TransCode's ability to continue as a going concern; risks associated with the timing and outcome of TransCode's planned regulatory submissions; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; risks of competition from other companies developing products for similar uses; risks associated with TransCode's dependence on third parties; and risks associated with geopolitical events and pandemics, including the COVID-19 coronavirus and military actions. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode's actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled &#34;Risk Factors&#34; in TransCode's Annual Report on Form 10-K for the year ended December 31, 2024, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the Securities and Exchange Commission. All information in this press release is as of the date of this release; TransCode undertakes no duty to update this information unless required by law.</p>
<div class="lb-trans"><p>本公告包含 1995 年《私人证券诉讼改革法案》所定义的 “前瞻性声明”，包括但不限于关于 TransCode 与 Quantum Leap 的合作时间、过程和结果的声明，TransCode 的 1a 期临床试验，TransCode 计划的 2a 期临床试验，以及将 TTX-MC138 纳入 PRE-I-SPY 项目进行 2a 期剂量扩展临床试验的声明，关于微小 RNA 及其在癌症中的作用的声明，以及关于 TransCode 的 TTX-MC138 和其他治疗候选药物的治疗潜力的声明。本新闻稿中的任何前瞻性声明均基于管理层对未来事件的当前预期，并受到多种风险和不确定性的影响，这些风险和不确定性可能导致实际结果与这些前瞻性声明中所列或暗示的结果存在重大不利差异。这些风险和不确定性包括但不限于：与药物发现和开发相关的风险；临床试验结果可能与 TransCode 的临床前研究或预期结果或之前临床试验的结果不一致的风险；与临床试验的进行相关的风险；与 TransCode 的财务状况及其需要获得额外资金以支持其业务活动相关的风险，包括 TransCode 继续作为持续经营的能力；与 TransCode 计划的监管提交的时间和结果相关的风险；与获得、维护和保护知识产权相关的风险；与 TransCode 对侵权者执行其专利和捍卫其专利组合免受第三方挑战的能力相关的风险；来自其他开发类似用途产品公司的竞争风险；与 TransCode 对第三方的依赖相关的风险；以及与地缘政治事件和疫情相关的风险，包括 COVID-19 冠状病毒和军事行动。有关这些及其他风险和不确定性的讨论，以及可能导致 TransCode 的实际结果与前瞻性声明中所包含或暗示的结果不同的其他重要因素，请参见 TransCode 截至 2024 年 12 月 31 日的 10-K 表格年度报告中的 “风险因素” 部分，以及 TransCode 向证券交易委员会提交的任何后续文件中对潜在风险、不确定性和其他重要因素的讨论。本新闻稿中的所有信息均截至发布之日；TransCode 不承担更新此信息的义务，除非法律要求。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2843185/Quantum_Leap_Healthcare_Collaborative.jpg" alt="" original-src="https://mma.prnewswire.com/media/2843185/Quantum_Leap_Healthcare_Collaborative.jpg"/></p>
<p>SOURCE TransCode Therapeutics, Inc.</p>
<div class="lb-trans"><p>来源：TransCode Therapeutics, Inc.</p>
</div>

TransCode Therapeutics and Quantum Leap Healthcare Collaborative Launch a Phase 2a dose-expansion trial with TTX-MC138, following positive readouts from TransCode's Phase 1 trial | RNAZ Stock News

TransCode Therapeutics 和 Quantum Leap Healthcare Collaborative 在 TransCode 的 1 期试验取得积极结果后，启动了 TTX-MC138 的 2a 期剂量扩展试验 | RNAZ 股票新闻