<ul>
<li>SLS009 与 AZA/VEN 联合使用在所有队列中达到了 46% 的总体反应率，在接受过一线治疗的患者中达到了 58% 的总体反应率，并且在经过 VEN 治疗的重度预处理急性髓性白血病 - 骨髓异常（AML-MR）患者中显示出令人鼓舞的生存结果。</li>
<li>在预处理最少的患者队列中，中位总生存期（mOS）为 8.9 个月；在所有队列中，接受过一线治疗的患者的 mOS 尚未达到，而历史基准约为 2.5 个月。</li>
<li>SLS009 30 mg 静脉注射每周两次与 AZA/VEN 联合使用是安全且可行的，未观察到剂量限制性毒性（DLTs）。</li>
<li>计划在 2026 年第一季度扩展研究，以评估 SLS009 与 AZA/VEN 联合用于新诊断的高风险特征急性髓性白血病。</li>
</ul>
<p>纽约，2025 年 12 月 7 日（GLOBE NEWSWIRE）——SELLAS 生命科学集团公司（NASDAQ: SLS）（“SELLAS” 或 “公司”），是一家专注于开发广泛癌症适应症新疗法的晚期临床生物制药公司，今天宣布其正在进行的 SLS009 的第二阶段临床研究的临床数据，该药物是一种高度选择性的 CDK9 抑制剂，与阿扎胞苷（AZA）和维奈克拉克（VEN）联合用于治疗经过 VEN 治疗后复发或难治性急性髓性白血病（AML）伴有骨髓异常变化（AML-MR）的患者，今天在 2025 年 12 月 6 日至 9 日在佛罗里达州奥兰多举行的第 67 届美国血液学会（ASH）年会上进行了展示。</p>
<p>在这项第二阶段扩展研究中，研究了 35 名可评估的复发/难治性 AML-MR 患者（N = 35），他们在之前接受过基于 VEN 的方案治疗，并且复发和/或对 VEN 耐药，然后接受 SLS009 与 AZA/VEN 联合治疗。参与患者的中位年龄为 69 岁，98% 的患者具有 ELN 不良风险 AML，最常见的突变为 ASXL1、RUNX1、TP53 和 SRSF2。</p>
<p>SLS009 与 AZA/VEN 联合使用在复发/难治性 AML-MR 患者中显示出临床上有意义的活性，在 35 名可评估患者中，总体反应率（CR+CRi+MLFS）为 46%，其中 29% 达到 CR/CRi。携带 ASXL1 或 TP53 突变的患者的反应率分别为 48%（19% CR/CRi）和 57%（29% CR/CRi）。中位总生存期（mOS）远高于该复发/难治性 AML 患者群体预期的 2.6 个月，在预处理最少的队列中，mOS 达到了 8.9 个月。在所有队列中，接受过一线治疗的患者获得了最大的益处，反应率为 58%，mOS 尚未达到。未观察到剂量限制性毒性（DLTs）或与治疗相关的死亡，且该组合耐受性良好。</p>
<p>“这些结果进一步强化了 SLS009 克服基于维奈克拉克方案耐药性的治疗潜力，通过抑制 MCL-1 的表达，这是 AML 中对 BCL-2 抑制的关键耐药机制，” SELLAS 的高级副总裁兼首席开发官 Dr. Dragan Cicic 表示。“SLS009 与阿扎胞苷和维奈克拉克的组合在重度预处理的不良风险 AML-MR 人群中显示出令人鼓舞的活性，包括那些携带 ASXL1 和 TP53 突变的患者。我们特别对在有限的先前治疗中获得的强烈反应感到鼓舞，并期待将这一组合方案扩展到新诊断的高风险特征急性髓性白血病中。”</p>
<p><strong>演示详情：</strong></p>
<p><strong>标题：</strong> SLS009 与阿扎胞苷和维奈克拉克联合用于复发/难治性 AML 伴有 MDS 相关变化（AML-MR）的第二阶段研究，经过先前维奈克拉克治疗后</p>
<p><strong>会议日期和演示时间</strong>：2025 年 12 月 7 日，东部标准时间下午 6:00 – 8:00</p>
<p><strong>会议标题：</strong> 616. 急性髓性白血病：研究药物和细胞疗法：海报 II</p>
<p><strong>地点</strong>：橙县会议中心（OCCC）– 西厅 B3-B4</p>
<p><strong>主要作者：</strong> Joshua F. Zeidner, MD，北卡罗来纳大学，莱因伯格综合癌症中心，教堂山，北卡罗来纳州</p>
<p><strong>出版编号</strong>：3423</p>
<p><strong>关于 SELLAS 生命科学集团公司</strong></p>
<p>SELLAS 是一家专注于开发广泛癌症适应症新疗法的晚期临床生物制药公司。SELLAS 的主要产品候选 GPS 是从纪念斯隆凯特琳癌症中心获得许可，靶向 WT1 蛋白，该蛋白存在于多种肿瘤类型中。GPS 作为单药治疗和与其他疗法联合使用，具有应对广泛血液恶性肿瘤和实体肿瘤适应症的潜力。公司还在开发 SLS009（tambiciclib）——可能是首个且最佳的差异化小分子 CDK9 抑制剂，与其他 CDK9 抑制剂相比，具有降低毒性和提高效力的特点。数据表明，SLS009 在具有不良预后因素的 AML 患者中显示出高反应率，包括 ASXL1 突变，这通常与各种髓系疾病的不良预后相关。有关 SELLAS 的更多信息，请访问 www.sellaslifesciences.com。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含前瞻性声明。除历史事实声明外的所有声明均为 “前瞻性声明”，包括与未来事件相关的声明。在某些情况下，前瞻性声明可以通过诸如 “计划”、“期望”、“预期”、“可能”、“或许”、“将”、“应该”、“项目”、“相信”、“估计”、“预测”、“潜在”、“打算” 或 “继续” 等术语及其他类似含义的词语来识别。这些声明包括但不限于与 GPS 临床开发计划相关的声明，包括 REGAL 研究及其相关未来里程碑的时间安排。这些前瞻性声明基于当前的计划、目标、估计、期望和意图，固有地涉及重大风险和不确定性。实际结果和事件的时间可能因这些风险和不确定性而与预期有重大差异，这些风险和不确定性包括但不限于肿瘤产品开发及其临床成功的风险和不确定性、监管批准的不确定性，以及影响 SELLAS 及其开发计划的其他风险和不确定性，具体见 SELLAS 于 2025 年 3 月 20 日提交的 10-K 表格年报中的 “风险因素” 标题下的内容。SELLAS 目前未意识到的其他风险和不确定性也可能影响 SELLAS 的前瞻性声明，并可能导致实际结果和事件的时间与预期有重大差异。此处的前瞻性声明仅在本日期作出。SELLAS 没有义务更新或补充任何前瞻性声明，以反映实际结果、新信息、未来事件、预期的变化或在前瞻性声明作出后存在的其他情况。</p>
<p><strong>投资者联系</strong></p>
<p>约翰·弗朗斯</p>
<p>董事总经理</p>
<p>LifeSci Advisors, LLC</p>
<p>jfraunces@lifesciadvisors.com</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RVNU56WTVNU00zTXpBNE5UazVJekl4TWpRek1qST0?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://www.globenewswire.com/newsroom/ti/query-bmY9T1RVNU56WTVNU00zTXpBNE5UazVJekl4TWpRek1qST0"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/N2ViYzVjMjgtNzk4ZC00MzJiLTg1NjUtZjMzYzBiMTJjM2Y2LTExMzU4OTMtMjAyNS0xMi0wNy1lbg==/tiny/SELLAS-Life-Sciences-Group-Inc.png?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://ml.globenewswire.com/media/N2ViYzVjMjgtNzk4ZC00MzJiLTg1NjUtZjMzYzBiMTJjM2Y2LTExMzU4OTMtMjAyNS0xMi0wNy1lbg==/tiny/SELLAS-Life-Sciences-Group-Inc.png"/></p>

<p>SELLAS Life Sciences 在 2025 年 ASH 大会上展示了 SLS009 联合 AZA/VEN 治疗复发/难治性急性髓系白血病（AML-MR）的积极二期数据。研究显示总体反应率为 46%，在接受过一次治疗的患者中反应率为 58%。在预处理最少的患者中，中位总生存期达到了 8.9 个月。该组合治疗安全，未出现剂量限制性毒性。计划在 2026 年第一季度扩展研究，以评估 SLS009 在新诊断的急性髓系白血病中的应用</p>

<ul>
<li><em>SLS009 in combination with AZA/VEN achieved a 46% overall response rate across all cohorts, a 58% overall response rate in</em> patients with one prior line of therapy, <em>and encouraging survival outcomes in heavily-pretreated AML-MR following prior VEN-based treatment</em></li>
<li><em>Median overall survival (mOS) of 8.9 months in the least pretreated patient cohort; across all cohorts, mOS was not yet reached in</em> patients with one prior line of therapy vs historical benchmark of approximately 2.5 months</li>
<li><em>SLS009 30 mg IV twice weekly added to AZA/VEN was safe and feasible, with no dose-limiting toxicities (DLTs) observed</em></li>
<li><em>Study expansion to evaluate SLS009 plus AZA/VEN in newly diagnosed AML with high-risk features is planned for Q1 2026</em></li>
</ul>
<div class="lb-trans"><ul>
<li>SLS009 与 AZA/VEN 联合使用在所有队列中达到了 46% 的总体反应率，在接受过一线治疗的患者中达到了 58% 的总体反应率，并且在经过 VEN 治疗的重度预处理急性髓性白血病 - 骨髓异常（AML-MR）患者中显示出令人鼓舞的生存结果。</li>
<li>在预处理最少的患者队列中，中位总生存期（mOS）为 8.9 个月；在所有队列中，接受过一线治疗的患者的 mOS 尚未达到，而历史基准约为 2.5 个月。</li>
<li>SLS009 30 mg 静脉注射每周两次与 AZA/VEN 联合使用是安全且可行的，未观察到剂量限制性毒性（DLTs）。</li>
<li>计划在 2026 年第一季度扩展研究，以评估 SLS009 与 AZA/VEN 联合用于新诊断的高风险特征急性髓性白血病。</li>
</ul>
</div><p>NEW YORK, Dec. 07, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that clinical data from its ongoing Phase 2 study of SLS009, a highly selective CDK9 inhibitor, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented today at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6 – 9, 2025, in Orlando, Florida.</p>
<div class="lb-trans"><p>纽约，2025 年 12 月 7 日（GLOBE NEWSWIRE）——SELLAS 生命科学集团公司（NASDAQ: SLS）（“SELLAS” 或 “公司”），是一家专注于开发广泛癌症适应症新疗法的晚期临床生物制药公司，今天宣布其正在进行的 SLS009 的第二阶段临床研究的临床数据，该药物是一种高度选择性的 CDK9 抑制剂，与阿扎胞苷（AZA）和维奈克拉克（VEN）联合用于治疗经过 VEN 治疗后复发或难治性急性髓性白血病（AML）伴有骨髓异常变化（AML-MR）的患者，今天在 2025 年 12 月 6 日至 9 日在佛罗里达州奥兰多举行的第 67 届美国血液学会（ASH）年会上进行了展示。</p>
</div><p>In this Phase 2 expansion study, R/R AML-MR patients (N = 35 evaluable) were studied in three separate cohorts (cohorts 3-5) who were previously treated with VEN-based regimens and either relapsed and/or were refractory to VEN and were then treated with SLS009 plus AZA/VEN. The median age of participating patients was 69 years, and 98% of patients had ELN adverse-risk AML, with the most frequent mutations being ASXL1, RUNX1, TP53, and SRSF2.</p>
<div class="lb-trans"><p>在这项第二阶段扩展研究中，研究了 35 名可评估的复发/难治性 AML-MR 患者（N = 35），他们在之前接受过基于 VEN 的方案治疗，并且复发和/或对 VEN 耐药，然后接受 SLS009 与 AZA/VEN 联合治疗。参与患者的中位年龄为 69 岁，98% 的患者具有 ELN 不良风险 AML，最常见的突变为 ASXL1、RUNX1、TP53 和 SRSF2。</p>
</div><p>SLS009 in combination with AZA/VEN demonstrated clinically meaningful activity in patients with R/R AML-MR, and among the 35 evaluable patients, the overall response rate (CR+CRi+MLFS) was 46%, including 29% achieving CR/CRi. Patients harboring <em>ASXL1</em> or <em>TP53</em> mutations achieved response rates of 48% (19% CR/CRi) and 57% (29% CR/CRi), respectively. The median overall survival (mOS) was exceedingly higher than the expected 2.6 months in this R/R AML patient population, and in the least pretreated cohort, mOS reached 8.9 months. Across all cohorts, patients with one prior line of therapy experienced the greatest benefit, with a 58% response rate and mOS not yet reached. No dose-limiting toxicities (DLTs) or treatment-related deaths were observed, and the combination was well tolerated.</p>
<div class="lb-trans"><p>SLS009 与 AZA/VEN 联合使用在复发/难治性 AML-MR 患者中显示出临床上有意义的活性，在 35 名可评估患者中，总体反应率（CR+CRi+MLFS）为 46%，其中 29% 达到 CR/CRi。携带 ASXL1 或 TP53 突变的患者的反应率分别为 48%（19% CR/CRi）和 57%（29% CR/CRi）。中位总生存期（mOS）远高于该复发/难治性 AML 患者群体预期的 2.6 个月，在预处理最少的队列中，mOS 达到了 8.9 个月。在所有队列中，接受过一线治疗的患者获得了最大的益处，反应率为 58%，mOS 尚未达到。未观察到剂量限制性毒性（DLTs）或与治疗相关的死亡，且该组合耐受性良好。</p>
</div><p>“These results further reinforce the therapeutic potential of SLS009 to overcome resistance to venetoclax-based regimens by suppressing the expression of MCL-1, a key mechanism of resistance to BCL-2 inhibition in AML,” said Dr. Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS. “The combination of SLS009 with azacitidine and venetoclax demonstrates encouraging activity in a heavily pretreated population with adverse-risk AML-MR, including those harboring <em>ASXL1</em> and <em>TP53</em> mutations. We are particularly encouraged by the strong responses in patients with limited prior therapy and look forward to expanding this combination regimen into newly diagnosed AML with high-risk features.”</p>
<div class="lb-trans"><p>“这些结果进一步强化了 SLS009 克服基于维奈克拉克方案耐药性的治疗潜力，通过抑制 MCL-1 的表达，这是 AML 中对 BCL-2 抑制的关键耐药机制，” SELLAS 的高级副总裁兼首席开发官 Dr. Dragan Cicic 表示。“SLS009 与阿扎胞苷和维奈克拉克的组合在重度预处理的不良风险 AML-MR 人群中显示出令人鼓舞的活性，包括那些携带 ASXL1 和 TP53 突变的患者。我们特别对在有限的先前治疗中获得的强烈反应感到鼓舞，并期待将这一组合方案扩展到新诊断的高风险特征急性髓性白血病中。”</p>
</div><p><strong>Presentation Details:</strong></p>
<div class="lb-trans"><p><strong>演示详情：</strong></p>
</div><p><strong>Title:</strong> Phase 2 Study of SLS009 in Combination with Azacitidine and Venetoclax for Relapsed/Refractory AML with MDS-Related Changes (AML-MR) After Prior Venetoclax Treatment</p>
<div class="lb-trans"><p><strong>标题：</strong> SLS009 与阿扎胞苷和维奈克拉克联合用于复发/难治性 AML 伴有 MDS 相关变化（AML-MR）的第二阶段研究，经过先前维奈克拉克治疗后</p>
</div><p><strong>Session Date and Presentation Time</strong>: Sunday, December 7, 2025, 6:00 – 8:00 PM EST</p>
<div class="lb-trans"><p><strong>会议日期和演示时间</strong>：2025 年 12 月 7 日，东部标准时间下午 6:00 – 8:00</p>
</div><p><strong>Session Title:</strong> 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II</p>
<div class="lb-trans"><p><strong>会议标题：</strong> 616. 急性髓性白血病：研究药物和细胞疗法：海报 II</p>
</div><p><strong>Location</strong>: Orange County Convention Center (OCCC) – West Halls B3-B4</p>
<div class="lb-trans"><p><strong>地点</strong>：橙县会议中心（OCCC）– 西厅 B3-B4</p>
</div><p><strong>Lead Author:</strong> Joshua F. Zeidner, MD, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC</p>
<div class="lb-trans"><p><strong>主要作者：</strong> Joshua F. Zeidner, MD，北卡罗来纳大学，莱因伯格综合癌症中心，教堂山，北卡罗来纳州</p>
</div><p><strong>Publication Number</strong>: 3423</p>
<div class="lb-trans"><p><strong>出版编号</strong>：3423</p>
</div><p><strong>About SELLAS Life Sciences Group, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 SELLAS 生命科学集团公司</strong></p>
</div><p>SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com.</p>
<div class="lb-trans"><p>SELLAS 是一家专注于开发广泛癌症适应症新疗法的晚期临床生物制药公司。SELLAS 的主要产品候选 GPS 是从纪念斯隆凯特琳癌症中心获得许可，靶向 WT1 蛋白，该蛋白存在于多种肿瘤类型中。GPS 作为单药治疗和与其他疗法联合使用，具有应对广泛血液恶性肿瘤和实体肿瘤适应症的潜力。公司还在开发 SLS009（tambiciclib）——可能是首个且最佳的差异化小分子 CDK9 抑制剂，与其他 CDK9 抑制剂相比，具有降低毒性和提高效力的特点。数据表明，SLS009 在具有不良预后因素的 AML 患者中显示出高反应率，包括 ASXL1 突变，这通常与各种髓系疾病的不良预后相关。有关 SELLAS 的更多信息，请访问 www.sellaslifesciences.com。</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. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made.</p>
<div class="lb-trans"><p>本新闻稿包含前瞻性声明。除历史事实声明外的所有声明均为 “前瞻性声明”，包括与未来事件相关的声明。在某些情况下，前瞻性声明可以通过诸如 “计划”、“期望”、“预期”、“可能”、“或许”、“将”、“应该”、“项目”、“相信”、“估计”、“预测”、“潜在”、“打算” 或 “继续” 等术语及其他类似含义的词语来识别。这些声明包括但不限于与 GPS 临床开发计划相关的声明，包括 REGAL 研究及其相关未来里程碑的时间安排。这些前瞻性声明基于当前的计划、目标、估计、期望和意图，固有地涉及重大风险和不确定性。实际结果和事件的时间可能因这些风险和不确定性而与预期有重大差异，这些风险和不确定性包括但不限于肿瘤产品开发及其临床成功的风险和不确定性、监管批准的不确定性，以及影响 SELLAS 及其开发计划的其他风险和不确定性，具体见 SELLAS 于 2025 年 3 月 20 日提交的 10-K 表格年报中的 “风险因素” 标题下的内容。SELLAS 目前未意识到的其他风险和不确定性也可能影响 SELLAS 的前瞻性声明，并可能导致实际结果和事件的时间与预期有重大差异。此处的前瞻性声明仅在本日期作出。SELLAS 没有义务更新或补充任何前瞻性声明，以反映实际结果、新信息、未来事件、预期的变化或在前瞻性声明作出后存在的其他情况。</p>
</div><p><strong>Investor Contact</strong></p>
<div class="lb-trans"><p><strong>投资者联系</strong></p>
</div><p>John Fraunces</p>
<div class="lb-trans"><p>约翰·弗朗斯</p>
</div><p>Managing Director</p>
<div class="lb-trans"><p>董事总经理</p>
</div><p>LifeSci Advisors, LLC</p>
<div class="lb-trans"><p>LifeSci Advisors, LLC</p>
</div><p>jfraunces@lifesciadvisors.com</p>
<div class="lb-trans"><p>jfraunces@lifesciadvisors.com</p>
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