<p><strong>FDA 批准使 Matter Bio 的減毒</strong> <strong><em>李斯特菌</em></strong> <strong>基礎免疫治療候選藥物 LM-LLO-TT 的首次人體 1/2a 期臨牀試驗得以啓動。</strong></p>
<p>, /PRNewswire/ -- Matter Bio 是一家開發針對難治性癌症的下一代免疫治療的生物技術公司，今天宣佈美國食品藥品監督管理局已批准該公司針對 LM-LLO-TT 的研究性新藥申請，該藥物是用於治療胰腺導管腺癌的減毒_李斯特菌_基礎免疫治療候選藥物。</p>
<p>FDA 的批准允許 Matter Bio 進行首次人體 1/2a 期臨牀試驗，旨在評估 LM-LLO-TT 在胰腺導管腺癌患者中的安全性、耐受性、劑量優化和初步抗腫瘤活性。</p>
<p>Matter Bio 首席執行官 Christopher Bradley 表示：&#34;這一 FDA 批准標誌着 Matter Bio 的重要里程碑，正式標誌着我們向臨牀階段公司的轉型。胰腺導管腺癌仍然是最具挑戰性的癌症之一，我們相信 LM-LLO-TT 有潛力以一種能夠顯著促進下一代癌症免疫治療的方式激活腫瘤定向免疫反應。&#34;</p>
<p>LM-LLO-TT 旨在利用減毒_李斯特菌_平台刺激針對腫瘤相關抗原的特定免疫活性。即將進行的 1/2a 期研究將評估 LM-LLO-TT 在胰腺導管腺癌患者中的效果，目標是確定合適的劑量並生成早期臨牀證據以支持進一步開發。</p>
<p>該 IND 批准是在 Matter Bio 之前宣佈的 IND 提交之後，反映了公司對 LM-LLO-TT 開發戰略的持續執行。</p>
<p>Matter Bio 首席科學官 Sam Sharifi 博士表示：&#34;這一里程碑是我們科學、臨牀、監管和製造團隊共同努力的結果。我們感謝幫助推進 LM-LLO-TT 至這一重要階段的合作伙伴和顧問，並期待啓動臨牀評估。&#34;</p>
<p><strong>關於 Matter Bio</strong></p>
<p>Matter Bio 是一家專注於開發針對難治性癌症的下一代免疫治療的生物技術公司。該公司正在將 LM-LLO-TT，一種減毒_李斯特菌_基礎免疫治療候選藥物，推進至胰腺導管腺癌的臨牀開發。LM-LLO-TT 旨在刺激難治性癌症（包括胰腺導管腺癌）中的腫瘤定向免疫反應。www.matter.bio</p>
<p><strong>前瞻性聲明</strong></p>
<p>本新聞稿包含前瞻性聲明，包括關於 Matter Bio 開發計劃、臨牀試驗的啓動和設計、LM-LLO-TT 的潛在治療益處以及公司對臨牀開發的預期。這些聲明基於當前的預期，並受到可能導致實際結果顯著不同的風險和不確定性的影響。LM-LLO-TT 為研究性藥物，尚未獲得 FDA 或任何其他監管機構的批准。Matter Bio 沒有義務更新任何前瞻性聲明，除非法律要求。</p>
<p><strong>媒體聯繫</strong>[email protected]</p>
<p>www.matter.bio</p>
<p>來源 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 宣佈，美國 FDA 已批准其針對 LM-LLO-TT 的臨牀試驗新藥（IND）申請，該藥物是一種用於胰腺導管腺癌的免疫療法候選藥物。此項批准使公司能夠啓動首個針對人類的 1/2a 期臨牀試驗，以評估該藥物的安全性、耐受性和初步抗腫瘤活性。首席執行官 Christopher Bradley 將此描述為 Matter Bio 轉型為臨牀階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 的減毒</strong> <strong><em>李斯特菌</em></strong> <strong>基礎免疫治療候選藥物 LM-LLO-TT 的首次人體 1/2a 期臨牀試驗得以啓動。</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 是一家開發針對難治性癌症的下一代免疫治療的生物技術公司，今天宣佈美國食品藥品監督管理局已批准該公司針對 LM-LLO-TT 的研究性新藥申請，該藥物是用於治療胰腺導管腺癌的減毒_李斯特菌_基礎免疫治療候選藥物。</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 的批准允許 Matter Bio 進行首次人體 1/2a 期臨牀試驗，旨在評估 LM-LLO-TT 在胰腺導管腺癌患者中的安全性、耐受性、劑量優化和初步抗腫瘤活性。</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 首席執行官 Christopher Bradley 表示：&#34;這一 FDA 批准標誌着 Matter Bio 的重要里程碑，正式標誌着我們向臨牀階段公司的轉型。胰腺導管腺癌仍然是最具挑戰性的癌症之一，我們相信 LM-LLO-TT 有潛力以一種能夠顯著促進下一代癌症免疫治療的方式激活腫瘤定向免疫反應。&#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 旨在利用減毒_李斯特菌_平台刺激針對腫瘤相關抗原的特定免疫活性。即將進行的 1/2a 期研究將評估 LM-LLO-TT 在胰腺導管腺癌患者中的效果，目標是確定合適的劑量並生成早期臨牀證據以支持進一步開發。</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>該 IND 批准是在 Matter Bio 之前宣佈的 IND 提交之後，反映了公司對 LM-LLO-TT 開發戰略的持續執行。</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 首席科學官 Sam Sharifi 博士表示：&#34;這一里程碑是我們科學、臨牀、監管和製造團隊共同努力的結果。我們感謝幫助推進 LM-LLO-TT 至這一重要階段的合作伙伴和顧問，並期待啓動臨牀評估。&#34;</p>
</div><p><strong>About Matter Bio</strong></p>
<div class="lb-trans"><p><strong>關於 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 是一家專注於開發針對難治性癌症的下一代免疫治療的生物技術公司。該公司正在將 LM-LLO-TT，一種減毒_李斯特菌_基礎免疫治療候選藥物，推進至胰腺導管腺癌的臨牀開發。LM-LLO-TT 旨在刺激難治性癌症（包括胰腺導管腺癌）中的腫瘤定向免疫反應。www.matter.bio</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性聲明</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>本新聞稿包含前瞻性聲明，包括關於 Matter Bio 開發計劃、臨牀試驗的啓動和設計、LM-LLO-TT 的潛在治療益處以及公司對臨牀開發的預期。這些聲明基於當前的預期，並受到可能導致實際結果顯著不同的風險和不確定性的影響。LM-LLO-TT 為研究性藥物，尚未獲得 FDA 或任何其他監管機構的批准。Matter Bio 沒有義務更新任何前瞻性聲明，除非法律要求。</p>
</div><p><strong>Media Contact</strong>[email protected]</p>
<div class="lb-trans"><p><strong>媒體聯繫</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>來源 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 宣佈 FDA 已批准其用於胰腺導管腺癌的 LM-LLO-TT 的 IND 申請