<p>馬薩諸塞州劍橋，2025 年 12 月 7 日（GLOBE NEWSWIRE）——Prime Medicine, Inc.（納斯達克：PRME），一家致力於提供新一類差異化一次性治癒性基因療法的生物技術公司，今天宣佈在《新英格蘭醫學雜誌》（NEJM）上發表了 PM359 的 1/2 期臨牀數據，該產品是公司針對 p47phox 慢性肉芽腫病（CGD）的研究性自體造血幹細胞產品。這些數據還將在 2025 年 12 月 6 日至 9 日在佛羅里達州奧蘭多舉行的第 67 屆美國血液學會（ASH）年會上以海報形式展示。</p>
<p>該出版物標題為 “針對 p47-phox 慢性肉芽腫病的 Prime Editing”，報告了在 PM359 的 1/2 期試驗中治療的兩名患者的初步數據，該試驗旨在評估成人和兒童研究參與者的安全性、生物活性和初步療效。兩名患者均經歷了快速的中性粒細胞和血小板植入，以及持久的 NADPH 氧化酶活性恢復和早期臨牀獲益，且沒有任何安全隱患。這些結果共同提供了 Prime Editing 在人體中的安全性和有效性的首次證明，並支持 PM359 作為 CGD 的精準治療策略的潛力：</p>
<ul>
<li>參與研究的兩名患者均有 CGD 相關併發症的病史，包括 CGD 相關性結腸炎（CAC）以及皮膚和軟組織感染，並且均接受長期預防治療。</li>
<li>兩名患者均經歷了快速的中性粒細胞植入，分別在第 30 天達到 69% 和 83% 的二氫羅丹明陽性（DHR+）中性粒細胞，遠遠超過 20% 的臨牀獲益最低預期閾值。兩名患者的 DHR 活性在一段時間內保持穩定，表明基因修正發生在骨髓的長期再生造血幹細胞（HSCs）中。</li>
<li>兩名患者在輸注後均未出現新的 CGD 相關併發症或顯著的合併疾病；此外，患者 1 停止了美沙拉嗪治療，未出現 CAC 復發，患者 2 的糞便鈣保護素水平顯著下降，慢性 CAC 症狀減輕。</li>
<li>在兩名患者中均未發生與 PM359 相關的臨牀顯著不良事件，所有觀察到的毒性均與以布斯爾法為基礎的預處理一致。</li>
</ul>
<p>“這些首次在人體中的數據的發表突顯了 Prime Editing 作為下一代治療平台的潛力，能夠為患者提供有意義的益處，並且可以在臨牀規模上進行生產和交付，” Prime Medicine 首席醫學官 Mohammed Asmal 博士表示。“除了展示早期臨牀療效外，這些結果還提供了關於 Prime Editing 安全性特徵和相較於其他基因編輯技術潛在優勢的重要見解。如在 NEJM 出版物中所述，我們觀察到在單次動員週期後可行修正細胞的高恢復率，以及輸注後造血系統的快速重建。這些都支持我們認為 Prime Editing 的機制不會引發雙鏈斷裂，可能比其他方法更易被 HSCs 和其他細胞類型耐受，因此對患者更安全。”</p>
<p><strong>關於 Prime Medicine</strong></p>
<p>Prime Medicine 是一家領先的生物技術公司，致力於為患者創造和提供下一代基因編輯療法。該公司正在部署其專有的 Prime Editing 平台，這是一種多功能、精確且高效的基因編輯技術，旨在開發新一類差異化的一次性治癒性基因療法。Prime Editors 旨在在基因內的正確位置進行正確的編輯，同時最小化不必要的 DNA 修改，具有修復幾乎所有類型基因突變的潛力，並在許多不同的組織、器官和細胞類型中發揮作用。綜合來看，Prime Editing 的多功能基因編輯能力可能會為數千種潛在適應症打開機會。</p>
<p>Prime Medicine 目前正在推進多樣化的研究性治療項目組合，圍繞我們的核心關注領域：肝臟、肺部以及免疫學和腫瘤學。在每個核心領域，Prime Medicine 最初專注於一組高價值項目，每個項目針對具有良好生物學理解和明確臨牀開發及監管路徑的疾病，並預計為擴展到其他機會奠定基礎。隨着時間的推移，該公司打算最大化 Prime Editing 廣泛而多樣的治療潛力，以及 Prime Editing 平台的模塊化，以快速高效地擴展到當前管道之外的疾病，可能包括其他遺傳疾病、免疫疾病、癌症、傳染病，以及針對常見疾病中的遺傳風險因素，這些疾病共同影響數百萬人。有關更多信息，請訪問 www.primemedicine.com。</p>
<p>© 2025 Prime Medicine, Inc. 保留所有權利。PRIME MEDICINE、Prime Medicine 標誌和 PASSIGE 是 Prime Medicine, Inc.的商標。所有其他商標均為其各自所有者的財產。</p>
<p><strong>前瞻性聲明</strong></p>
<p>本新聞稿包含 1995 年《私人證券訴訟改革法案》修訂版所定義的前瞻性聲明，包括但不限於關於 Prime Medicine 的信念和期望的隱含和明確聲明：關於其 PM359 的 1/2 期試驗數據的重要性；PM359 作為一種精準且安全的 CGD 治療策略的潛力；Prime Editing 的安全性和有效性，包括與其他方法的比較；Prime Editing 糾正致病突變和治癒疾病的潛力；其業務、項目和技術的戰略計劃；以及 Prime Editing 在數千種潛在適應症中解鎖機會的潛力。</p>
<p>本新聞稿中的任何前瞻性聲明均基於管理層當前的期望和信念，並受到多種風險、不確定性和重要因素的影響，這些因素可能導致實際事件或結果與本新聞稿中表達或暗示的任何前瞻性聲明存在重大差異，包括但不限於與以下內容相關的風險：與 Prime Medicine 的產品候選者進入臨牀試驗相關的不確定性；潛在產品候選者的臨牀前和 IND 啓用研究的授權、啓動和實施，以及其他開發要求的不確定性，包括與開設 IND 和獲得監管批准相關的不確定性；與新技術的開發和優化相關的風險，臨牀前研究或臨牀研究的結果未能預測未來研究的結果；Prime Medicine 能夠建立和維護其 Prime Editing 技術的知識產權保護範圍；Prime Medicine 識別和簽訂未來許可協議和合作的能力；Prime Medicine 對其現金流持續時間和未來財務表現的預期；以及一般經濟、行業和市場條件。這些風險和不確定性在 Prime Medicine 最近的 10-K 表格年度報告中的 “風險因素” 部分以及隨後的任何向證券交易委員會的提交文件中有更詳細的描述。此外，任何前瞻性聲明僅代表 Prime Medicine 截至今天的觀點，不應被視為其在任何後續日期的觀點。Prime Medicine 明確聲明不承擔根據適用法律更新任何前瞻性聲明的義務。對於任何此類前瞻性聲明的準確性，不作任何明示或暗示的陳述或保證。</p>
<p><strong>投資者和媒體聯繫人</strong></p>
<p>Gregory Dearborn</p>
<p>Prime Medicine</p>
<p>857-209-0696</p>
<p>gdearborn@primemedicine.com</p>
<p>Hannah Deresiewicz</p>
<p>Precision AQ</p>
<p>212-362-1200</p>
<p>hannah.deresiewicz@precisionaq.com</p>
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PRME

<p>Prime Medicine 宣佈在《新英格蘭醫學雜誌》上發表了 PM359 的 1/2 期臨牀數據，這是一種用於慢性肉芽腫病的基因療法。數據顯示了安全性和有效性，並將在 ASH 年會上進行展示。試驗中的兩名患者均顯示出顯著的臨牀益處且沒有安全隱患，突顯了 Prime Editing 作為治療平台的潛力。Prime Medicine 旨在將其基因編輯療法擴展到多種疾病</p>

<p>CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced the publication of Phase 1/2 clinical data with PM359, the Company’s investigational autologous hematopoietic stem cell product for p47phox chronic granulomatous disease (CGD) in the <em>New England Journal of Medicine (NEJM).</em> The data will also be presented in a poster session at the 67th American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025 in Orlando, Florida.</p>
<div class="lb-trans"><p>馬薩諸塞州劍橋，2025 年 12 月 7 日（GLOBE NEWSWIRE）——Prime Medicine, Inc.（納斯達克：PRME），一家致力於提供新一類差異化一次性治癒性基因療法的生物技術公司，今天宣佈在《新英格蘭醫學雜誌》（NEJM）上發表了 PM359 的 1/2 期臨牀數據，該產品是公司針對 p47phox 慢性肉芽腫病（CGD）的研究性自體造血幹細胞產品。這些數據還將在 2025 年 12 月 6 日至 9 日在佛羅里達州奧蘭多舉行的第 67 屆美國血液學會（ASH）年會上以海報形式展示。</p>
</div><p>The publication, titled “Prime Editing for p47-phox Chronic Granulomatous Disease,” reports initial data for two patients treated in the Phase 1/2 trial of PM359, which was designed to assess safety, biological activity and preliminary efficacy in adult and pediatric study participants. Both patients experienced rapid neutrophil and platelet engraftment, as well as durable restoration of NADPH oxidase activity and early clinical benefit, without any safety concerns. Together, these results provide the first-in-human demonstration of the safety and efficacy of Prime Editing, and support the potential for PM359 as a precise therapeutic strategy for CGD:</p>
<div class="lb-trans"><p>該出版物標題為 “針對 p47-phox 慢性肉芽腫病的 Prime Editing”，報告了在 PM359 的 1/2 期試驗中治療的兩名患者的初步數據，該試驗旨在評估成人和兒童研究參與者的安全性、生物活性和初步療效。兩名患者均經歷了快速的中性粒細胞和血小板植入，以及持久的 NADPH 氧化酶活性恢復和早期臨牀獲益，且沒有任何安全隱患。這些結果共同提供了 Prime Editing 在人體中的安全性和有效性的首次證明，並支持 PM359 作為 CGD 的精準治療策略的潛力：</p>
</div><ul>
<li>Both patients enrolled in the study had a history of prior CGD-defining complications, including CGD-associated colitis (CAC), and skin and soft tissue infections, and both were maintained on long-term prophylactic therapy.</li>
<li>Both patients experienced rapid neutrophil engraftment, achieving 69% and 83% dihydrorhodamine-positive (DHR+) neutrophils by Day 30, respectively, far in excess of the 20% projected minimum threshold for clinical benefit. DHR activity remained stable over time in both patients, suggesting that gene correction occurred in the long-term repopulating hematopoietic stem cells (HSCs) of the bone marrow.</li>
<li>Both patients remain free of new CGD-related complications or significant intercurrent illnesses post-infusion; additionally, Patient 1 stopped his mesalamine treatment and has not experienced a flare of CAC, and Patient 2’s levels of fecal calprotectin have decreased substantially, and his chronic CAC symptoms have abated.</li>
<li>No clinically significant adverse events attributable to PM359 occurred in either patient, and all observed toxicities were consistent with busulfan-based conditioning.</li>
</ul>
<div class="lb-trans"><ul>
<li>參與研究的兩名患者均有 CGD 相關併發症的病史，包括 CGD 相關性結腸炎（CAC）以及皮膚和軟組織感染，並且均接受長期預防治療。</li>
<li>兩名患者均經歷了快速的中性粒細胞植入，分別在第 30 天達到 69% 和 83% 的二氫羅丹明陽性（DHR+）中性粒細胞，遠遠超過 20% 的臨牀獲益最低預期閾值。兩名患者的 DHR 活性在一段時間內保持穩定，表明基因修正發生在骨髓的長期再生造血幹細胞（HSCs）中。</li>
<li>兩名患者在輸注後均未出現新的 CGD 相關併發症或顯著的合併疾病；此外，患者 1 停止了美沙拉嗪治療，未出現 CAC 復發，患者 2 的糞便鈣保護素水平顯著下降，慢性 CAC 症狀減輕。</li>
<li>在兩名患者中均未發生與 PM359 相關的臨牀顯著不良事件，所有觀察到的毒性均與以布斯爾法為基礎的預處理一致。</li>
</ul>
</div><p>“Publication of these first-in-human data highlights Prime Editing’s promise as a next-generation therapeutic platform, which is capable of delivering meaningful benefits to patients and which can be manufactured and delivered at clinical scale,” said Mohammed Asmal, M.D., Ph.D., Chief Medical Officer of Prime Medicine. “Beyond demonstrating early clinical efficacy, these results offer important insights into Prime Editing’s safety profile and potential advantages over other gene editing technologies. As described in the <em>NEJM</em> publication, we observed high recovery rates of viable corrected cells after a single mobilization cycle, as well as the rapid reconstitution of the hematopoietic system after infusion. Both support our belief that the mechanism of Prime Editing, which does not induce double-strand breaks, may be better tolerated by HSCs and other cell types – and therefore safer for patients – than other approaches.”</p>
<div class="lb-trans"><p>“這些首次在人體中的數據的發表突顯了 Prime Editing 作為下一代治療平台的潛力，能夠為患者提供有意義的益處，並且可以在臨牀規模上進行生產和交付，” Prime Medicine 首席醫學官 Mohammed Asmal 博士表示。“除了展示早期臨牀療效外，這些結果還提供了關於 Prime Editing 安全性特徵和相較於其他基因編輯技術潛在優勢的重要見解。如在 NEJM 出版物中所述，我們觀察到在單次動員週期後可行修正細胞的高恢復率，以及輸注後造血系統的快速重建。這些都支持我們認為 Prime Editing 的機制不會引發雙鏈斷裂，可能比其他方法更易被 HSCs 和其他細胞類型耐受，因此對患者更安全。”</p>
</div><p><strong>About Prime Medicine</strong></p>
<div class="lb-trans"><p><strong>關於 Prime Medicine</strong></p>
</div><p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is deploying its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated one-time curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Taken together, Prime Editing’s versatile gene editing capabilities could unlock opportunities across thousands of potential indications.</p>
<div class="lb-trans"><p>Prime Medicine 是一家領先的生物技術公司，致力於為患者創造和提供下一代基因編輯療法。該公司正在部署其專有的 Prime Editing 平台，這是一種多功能、精確且高效的基因編輯技術，旨在開發新一類差異化的一次性治癒性基因療法。Prime Editors 旨在在基因內的正確位置進行正確的編輯，同時最小化不必要的 DNA 修改，具有修復幾乎所有類型基因突變的潛力，並在許多不同的組織、器官和細胞類型中發揮作用。綜合來看，Prime Editing 的多功能基因編輯能力可能會為數千種潛在適應症打開機會。</p>
</div><p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: liver, lung, and immunology and oncology. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. Over time, the Company intends to maximize Prime Editing’s broad and versatile therapeutic potential, as well as the modularity of the Prime Editing platform, to rapidly and efficiently expand beyond the diseases in its current pipeline, potentially including additional genetic diseases, immunological diseases, cancers, infectious diseases, and targeting genetic risk factors in common diseases, which collectively impact millions of people. For more information, please visit www.primemedicine.com.</p>
<div class="lb-trans"><p>Prime Medicine 目前正在推進多樣化的研究性治療項目組合，圍繞我們的核心關注領域：肝臟、肺部以及免疫學和腫瘤學。在每個核心領域，Prime Medicine 最初專注於一組高價值項目，每個項目針對具有良好生物學理解和明確臨牀開發及監管路徑的疾病，並預計為擴展到其他機會奠定基礎。隨着時間的推移，該公司打算最大化 Prime Editing 廣泛而多樣的治療潛力，以及 Prime Editing 平台的模塊化，以快速高效地擴展到當前管道之外的疾病，可能包括其他遺傳疾病、免疫疾病、癌症、傳染病，以及針對常見疾病中的遺傳風險因素，這些疾病共同影響數百萬人。有關更多信息，請訪問 www.primemedicine.com。</p>
</div><p>© 2025 Prime Medicine, Inc. All rights reserved. PRIME MEDICINE, the Prime Medicine logos, and PASSIGE are trademarks of Prime Medicine, Inc. All other trademarks referred to herein are the property of their respective owners.</p>
<div class="lb-trans"><p>© 2025 Prime Medicine, Inc. 保留所有權利。PRIME MEDICINE、Prime Medicine 標誌和 PASSIGE 是 Prime Medicine, Inc.的商標。所有其他商標均為其各自所有者的財產。</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 within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Prime Medicine’s beliefs and expectations regarding: the significance of data from its Phase 1/2 trial of PM359; the potential for PM359 to be a precise and safe therapeutic strategy for CGD;; the safety and efficacy of Prime Editing, including in comparison to other approaches; the potential of Prime Editing to correct the causative mutations of, and to cure, diseases; its strategic plans for its business, programs, and technology; and the potential of Prime Editing to unlock opportunities across thousands of potential indications.</p>
<div class="lb-trans"><p>本新聞稿包含 1995 年《私人證券訴訟改革法案》修訂版所定義的前瞻性聲明，包括但不限於關於 Prime Medicine 的信念和期望的隱含和明確聲明：關於其 PM359 的 1/2 期試驗數據的重要性；PM359 作為一種精準且安全的 CGD 治療策略的潛力；Prime Editing 的安全性和有效性，包括與其他方法的比較；Prime Editing 糾正致病突變和治癒疾病的潛力；其業務、項目和技術的戰略計劃；以及 Prime Editing 在數千種潛在適應症中解鎖機會的潛力。</p>
</div><p>Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties related to Prime Medicine’s product candidates entering clinical trials; the authorization, initiation, and conduct of preclinical and IND-enabling studies and other development requirements for potential product candidates, including uncertainties related to opening INDs and obtaining regulatory approvals; risks related to the development and optimization of new technologies, the results of preclinical studies, or clinical studies not being predictive of future results in connection with future studies; the scope of protection Prime Medicine is able to establish and maintain for intellectual property rights covering its Prime Editing technology; Prime Medicine’s ability to identify and enter into future license agreements and collaborations; Prime Medicine’s expectations regarding the anticipated timeline of its cash runway and future financial performance; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Prime Medicine’s most recent Annual Report on Form 10-K, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Prime Medicine’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Prime Medicine explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.</p>
<div class="lb-trans"><p>本新聞稿中的任何前瞻性聲明均基於管理層當前的期望和信念，並受到多種風險、不確定性和重要因素的影響，這些因素可能導致實際事件或結果與本新聞稿中表達或暗示的任何前瞻性聲明存在重大差異，包括但不限於與以下內容相關的風險：與 Prime Medicine 的產品候選者進入臨牀試驗相關的不確定性；潛在產品候選者的臨牀前和 IND 啓用研究的授權、啓動和實施，以及其他開發要求的不確定性，包括與開設 IND 和獲得監管批准相關的不確定性；與新技術的開發和優化相關的風險，臨牀前研究或臨牀研究的結果未能預測未來研究的結果；Prime Medicine 能夠建立和維護其 Prime Editing 技術的知識產權保護範圍；Prime Medicine 識別和簽訂未來許可協議和合作的能力；Prime Medicine 對其現金流持續時間和未來財務表現的預期；以及一般經濟、行業和市場條件。這些風險和不確定性在 Prime Medicine 最近的 10-K 表格年度報告中的 “風險因素” 部分以及隨後的任何向證券交易委員會的提交文件中有更詳細的描述。此外，任何前瞻性聲明僅代表 Prime Medicine 截至今天的觀點，不應被視為其在任何後續日期的觀點。Prime Medicine 明確聲明不承擔根據適用法律更新任何前瞻性聲明的義務。對於任何此類前瞻性聲明的準確性，不作任何明示或暗示的陳述或保證。</p>
</div><p><strong>Investor and Media Contacts</strong></p>
<div class="lb-trans"><p><strong>投資者和媒體聯繫人</strong></p>
</div><p>Gregory Dearborn</p>
<div class="lb-trans"><p>Gregory Dearborn</p>
</div><p>Prime Medicine</p>
<div class="lb-trans"><p>Prime Medicine</p>
</div><p>857-209-0696</p>
<div class="lb-trans"><p>857-209-0696</p>
</div><p>gdearborn@primemedicine.com</p>
<div class="lb-trans"><p>gdearborn@primemedicine.com</p>
</div><p>Hannah Deresiewicz</p>
<div class="lb-trans"><p>Hannah Deresiewicz</p>
</div><p>Precision AQ</p>
<div class="lb-trans"><p>Precision AQ</p>
</div><p>212-362-1200</p>
<div class="lb-trans"><p>212-362-1200</p>
</div><p>hannah.deresiewicz@precisionaq.com</p>
<div class="lb-trans"><p>hannah.deresiewicz@precisionaq.com</p>
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Prime Medicine Announces The New England Journal of Medicine Publication of PM359  Clinical Data for the Treatment of Chronic Granulomatous Disease | PRME Stock News

Prime Medicine 宣佈《新英格蘭醫學雜誌》發表關於 PM359 用於治療慢性肉芽腫病的臨牀數據 | PRME 股票新聞