<p><strong>FDA 批准使 Matter Bio 的减毒</strong> <strong><em>李斯特菌</em></strong> <strong>基础免疫治疗候选药物 LM-LLO-TT 的首次人体 1/2a 期临床试验得以启动。</strong></p>
<p>, /PRNewswire/ -- Matter Bio 是一家开发针对难治性癌症的下一代免疫治疗的生物技术公司，今天宣布美国食品药品监督管理局已批准该公司针对 LM-LLO-TT 的研究性新药申请，该药物是用于治疗胰腺导管腺癌的减毒_李斯特菌_基础免疫治疗候选药物。</p>
<p>FDA 的批准允许 Matter Bio 进行首次人体 1/2a 期临床试验，旨在评估 LM-LLO-TT 在胰腺导管腺癌患者中的安全性、耐受性、剂量优化和初步抗肿瘤活性。</p>
<p>Matter Bio 首席执行官 Christopher Bradley 表示：&#34;这一 FDA 批准标志着 Matter Bio 的重要里程碑，正式标志着我们向临床阶段公司的转型。胰腺导管腺癌仍然是最具挑战性的癌症之一，我们相信 LM-LLO-TT 有潜力以一种能够显著促进下一代癌症免疫治疗的方式激活肿瘤定向免疫反应。&#34;</p>
<p>LM-LLO-TT 旨在利用减毒_李斯特菌_平台刺激针对肿瘤相关抗原的特定免疫活性。即将进行的 1/2a 期研究将评估 LM-LLO-TT 在胰腺导管腺癌患者中的效果，目标是确定合适的剂量并生成早期临床证据以支持进一步开发。</p>
<p>该 IND 批准是在 Matter Bio 之前宣布的 IND 提交之后，反映了公司对 LM-LLO-TT 开发战略的持续执行。</p>
<p>Matter Bio 首席科学官 Sam Sharifi 博士表示：&#34;这一里程碑是我们科学、临床、监管和制造团队共同努力的结果。我们感谢帮助推进 LM-LLO-TT 至这一重要阶段的合作伙伴和顾问，并期待启动临床评估。&#34;</p>
<p><strong>关于 Matter Bio</strong></p>
<p>Matter Bio 是一家专注于开发针对难治性癌症的下一代免疫治疗的生物技术公司。该公司正在将 LM-LLO-TT，一种减毒_李斯特菌_基础免疫治疗候选药物，推进至胰腺导管腺癌的临床开发。LM-LLO-TT 旨在刺激难治性癌症（包括胰腺导管腺癌）中的肿瘤定向免疫反应。www.matter.bio</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含前瞻性声明，包括关于 Matter Bio 开发计划、临床试验的启动和设计、LM-LLO-TT 的潜在治疗益处以及公司对临床开发的预期。这些声明基于当前的预期，并受到可能导致实际结果显著不同的风险和不确定性的影响。LM-LLO-TT 为研究性药物，尚未获得 FDA 或任何其他监管机构的批准。Matter Bio 没有义务更新任何前瞻性声明，除非法律要求。</p>
<p><strong>媒体联系</strong>[email protected]</p>
<p>www.matter.bio</p>
<p>来源 Matter Bio</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNjEwJk5ld3NJdGVtSWQ9TE44MDQwNyZUcmFuc21pc3Npb25fSWQ9MjAyNjA2MTAwOTA0UFJfTkVXU19VU1BSX19fX19MTjgwNDA3?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-RGF0ZUlkPTIwMjYwNjEwJk5ld3NJdGVtSWQ9TE44MDQwNyZUcmFuc21pc3Npb25fSWQ9MjAyNjA2MTAwOTA0UFJfTkVXU19VU1BSX19fX19MTjgwNDA3"/></p>

<p>Matter Bio 宣布，美国 FDA 已批准其针对 LM-LLO-TT 的临床试验新药（IND）申请，该药物是一种用于胰腺导管腺癌的免疫疗法候选药物。此项批准使公司能够启动首个针对人类的 1/2a 期临床试验，以评估该药物的安全性、耐受性和初步抗肿瘤活性。首席执行官 Christopher Bradley 将此描述为 Matter Bio 转型为临床阶段公司的重要里程碑</p>

<p><strong>FDA clearance enables initiation of first-in-human Phase 1/2a clinical trial evaluating LM-LLO-TT, Matter Bio's attenuated</strong> <strong><em>Listeria monocytogenes</em></strong> <strong>-based immunotherapy candidate.</strong></p>
<div class="lb-trans"><p><strong>FDA 批准使 Matter Bio 的减毒</strong> <strong><em>李斯特菌</em></strong> <strong>基础免疫治疗候选药物 LM-LLO-TT 的首次人体 1/2a 期临床试验得以启动。</strong></p>
</div><p>, /PRNewswire/ -- Matter Bio, a biotechnology company developing next-generation immunotherapies for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug application for LM-LLO-TT, its attenuated <em>Listeria monocytogenes</em>-based immunotherapy candidate for the treatment of pancreatic ductal adenocarcinoma.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- Matter Bio 是一家开发针对难治性癌症的下一代免疫治疗的生物技术公司，今天宣布美国食品药品监督管理局已批准该公司针对 LM-LLO-TT 的研究性新药申请，该药物是用于治疗胰腺导管腺癌的减毒_李斯特菌_基础免疫治疗候选药物。</p>
</div><p>The FDA clearance allows Matter Bio to proceed with a first-in-human Phase 1/2a clinical trial designed to evaluate the safety, tolerability, dose optimization, and preliminary anti-tumor activity of LM-LLO-TT in patients with pancreatic ductal adenocarcinoma.</p>
<div class="lb-trans"><p>FDA 的批准允许 Matter Bio 进行首次人体 1/2a 期临床试验，旨在评估 LM-LLO-TT 在胰腺导管腺癌患者中的安全性、耐受性、剂量优化和初步抗肿瘤活性。</p>
</div><p>&#34;This FDA clearance represents a major milestone for Matter Bio and marks our official transition into a clinical-stage company,&#34; said Christopher Bradley, CEO of Matter Bio. &#34;Pancreatic ductal adenocarcinoma remains one of the most challenging cancers to treat, and we believe LM-LLO-TT has the potential to activate tumor-directed immune responses in a way that could meaningfully contribute to the next generation of cancer immunotherapy.&#34;</p>
<div class="lb-trans"><p>Matter Bio 首席执行官 Christopher Bradley 表示：&#34;这一 FDA 批准标志着 Matter Bio 的重要里程碑，正式标志着我们向临床阶段公司的转型。胰腺导管腺癌仍然是最具挑战性的癌症之一，我们相信 LM-LLO-TT 有潜力以一种能够显著促进下一代癌症免疫治疗的方式激活肿瘤定向免疫反应。&#34;</p>
</div><p>LM-LLO-TT is designed to leverage an attenuated <em>Listeria monocytogenes</em> platform to stimulate targeted immune activity against tumor-associated antigens. The upcoming Phase 1/2a study will assess LM-LLO-TT in patients with pancreatic ductal adenocarcinoma, with the goal of establishing an appropriate dose and generating early clinical evidence to support further development.</p>
<div class="lb-trans"><p>LM-LLO-TT 旨在利用减毒_李斯特菌_平台刺激针对肿瘤相关抗原的特定免疫活性。即将进行的 1/2a 期研究将评估 LM-LLO-TT 在胰腺导管腺癌患者中的效果，目标是确定合适的剂量并生成早期临床证据以支持进一步开发。</p>
</div><p>The IND clearance follows Matter Bio's previously announced IND submission and reflects continued execution of the Company's development strategy for LM-LLO-TT.</p>
<div class="lb-trans"><p>该 IND 批准是在 Matter Bio 之前宣布的 IND 提交之后，反映了公司对 LM-LLO-TT 开发战略的持续执行。</p>
</div><p>&#34;This milestone is the result of significant work across our scientific, clinical, regulatory, and manufacturing teams,&#34; said Dr. Sam Sharifi, CSO of Matter Bio. &#34;We are grateful to our collaborators and advisors who have helped advance LM-LLO-TT to this important stage, and we look forward to initiating clinical evaluation.&#34;</p>
<div class="lb-trans"><p>Matter Bio 首席科学官 Sam Sharifi 博士表示：&#34;这一里程碑是我们科学、临床、监管和制造团队共同努力的结果。我们感谢帮助推进 LM-LLO-TT 至这一重要阶段的合作伙伴和顾问，并期待启动临床评估。&#34;</p>
</div><p><strong>About Matter Bio</strong></p>
<div class="lb-trans"><p><strong>关于 Matter Bio</strong></p>
</div><p>Matter Bio is a biotechnology company focused on developing next-generation immunotherapies for difficult-to-treat cancers. The Company is advancing LM-LLO-TT, an attenuated <em>Listeria monocytogenes</em>-based immunotherapy candidate, into clinical development for pancreatic ductal adenocarcinoma. LM-LLO-TT is designed to stimulate tumor-directed immune responses in difficult-to-treat cancers, including pancreatic ductal adenocarcinoma. www.matter.bio</p>
<div class="lb-trans"><p>Matter Bio 是一家专注于开发针对难治性癌症的下一代免疫治疗的生物技术公司。该公司正在将 LM-LLO-TT，一种减毒_李斯特菌_基础免疫治疗候选药物，推进至胰腺导管腺癌的临床开发。LM-LLO-TT 旨在刺激难治性癌症（包括胰腺导管腺癌）中的肿瘤定向免疫反应。www.matter.bio</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, including statements regarding Matter Bio's development plans, the initiation and design of clinical trials, the potential therapeutic benefits of LM-LLO-TT, and the Company's expectations regarding clinical development. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. LM-LLO-TT is investigational and has not been approved by the FDA or any other regulatory authority. Matter Bio undertakes no obligation to update any forward-looking statements except as required by law.</p>
<div class="lb-trans"><p>本新闻稿包含前瞻性声明，包括关于 Matter Bio 开发计划、临床试验的启动和设计、LM-LLO-TT 的潜在治疗益处以及公司对临床开发的预期。这些声明基于当前的预期，并受到可能导致实际结果显著不同的风险和不确定性的影响。LM-LLO-TT 为研究性药物，尚未获得 FDA 或任何其他监管机构的批准。Matter Bio 没有义务更新任何前瞻性声明，除非法律要求。</p>
</div><p><strong>Media Contact</strong>[email protected]</p>
<div class="lb-trans"><p><strong>媒体联系</strong>[email protected]</p>
</div><p>www.matter.bio</p>
<div class="lb-trans"><p>www.matter.bio</p>
</div><p>SOURCE Matter Bio</p>
<div class="lb-trans"><p>来源 Matter Bio</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNjEwJk5ld3NJdGVtSWQ9TE44MDQwNyZUcmFuc21pc3Npb25fSWQ9MjAyNjA2MTAwOTA0UFJfTkVXU19VU1BSX19fX19MTjgwNDA3" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=LN80407&amp;Transmission_Id=202606100904PR_NEWS_USPR_____LN80407&amp;DateId=20260610"/></p>

09:25 ET Matter Bio 宣布 FDA 已批准其用于胰腺导管腺癌的 LM-LLO-TT 的 IND 申请