Pembrolizumab

Second cohort findings consistent with previously reported observations; independent statistical analysis planned following completion of all three patient cohorts SAN DIEGO, July 13, 2026 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company developing products to treat cancer and life-threatening viral infections, today announced that patients in the second cohort of its Australian oncology feasibility study demonstrated biological changes consistent with those previously observed in the first cohort following treatment with the investigational Hemopurifier®. Replicating these findings in a second group of patients strengthens the scientific rationale for the Company's ongoing clinical program and supports continued enrollment in the third and final cohort before an independent statistical analysis is conducted. "We are encouraged to observe similar directional changes across multiple biomarkers in both the first and second patient cohorts," said James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. " Observing these directional changes in a second patient cohort builds upon our initial observations and provides additional data as we advance toward completion of the third cohort. While these are preliminary findings from an early feasibility study, they represent an important milestone as we advance toward completion of the third cohort and an independent statistical analysis to determine whether these observations represent a dose-response to Hemopurifier treatment." The Australian feasibility study is evaluating the safety, feasibility and dosing of the Hemopurifier® in patients with advanced solid tumors whose cancers have progressed despite treatment with anti-PD-1 immunotherapies. The second cohort continued to show directional changes in several biomarkers that researchers believe are associated with tumor growth, immune suppression and response to immunotherapy, including: Reductions in tumor-derived extracellular vesicles (EVs), platelet-derived EVs and PD-L1-positive EVs, with these changes appearing more consistently across all participants than in the first cohort and generally persisting through the eight-week follow-up period. Reductions in two microRNAs that have been associated with tumor growth and cancer invasion. Improvements in multiple immune-related laboratory ratios—including neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), Systemic Immune-Inflammation Index (SII), monocyte-to-albumin ratio (MAR) and Lymphocyte Albumin Index (LAI)—that have been associated in published research with improved responses to immunotherapy. Increases in total T cells, CD4 and CD8 T-cell populations, and tumor-specific CD137-positive T cells in all three participants, with these changes generally persisting through the eight-week follow-up period. Taken together, the first two cohorts have now shown similar directional changes across multiple biological markers following Hemopurifier treatment. Enrollment in the third cohort is underway, with the first participant having already completed three four-hour Hemopurifier treatments during a one-week period. After all three cohorts are complete, an independent statistician will analyze the combined data to determine whether these observations support a dose-response relationship. EVs continue to be recognized as important drivers of cancer progression and resistance to checkpoint inhibitors such as Keytruda® and Opdivo®. The Hemopurifier® is designed to remove these tumor-derived vesicles from the bloodstream, with the goal of reducing immune suppression and potentially enhancing the body's ability to fight cancer. "We believe the Hemopurifier has the ability to complement existing therapies rather than replace them and could be a platform technology with potential applications across multiple disease areas such as oncology, infectious diseases, and future emerging threats. We believe there exists a 'pipeline within a single device,'" said Mr. Frakes. Advancing a Novel Approach to Cancer Immunotherapy Extracellular vesicles released by tumors continue to be recognized as important drivers of cancer progression, metastasis and resistance to immunotherapy. EVs expressing PD-L1 have been associated with resistance to checkpoint inhibitors, including Keytruda® and Opdivo®. The Hemopurifier is designed to remove tumor-derived EVs and other pathogenic particles from circulation, potentially reducing immunosuppressive signaling and improving the body's anti-tumor immune response. The Hemopurifier has received FDA Breakthrough Device Designation for the treatment of patients with advanced or metastatic cancer who are unresponsive or intolerant to standard-of-care therapy, as well as for the treatment of life-threatening viral infections not addressed by approved therapies. Important Study Limitations The Company cautions that these findings represent descriptive observations from raw data generated in an early-stage feasibility study. Formal statistical analyses have not yet been performed and will be conducted only after completion of all three study cohorts by an independent statistician. The study was not designed to demonstrate clinical efficacy, and no conclusions can be drawn regarding the Hemopurifier's impact on patient outcomes. Larger, adequately powered clinical trials designed with clinical efficacy endpoints will be required to determine whether the biological changes observed translate into meaningful clinical benefit. About Aethlon Medical Aethlon Medical, Inc. is developing the Hemopurifier®, an investigational extracorporeal therapeutic designed to remove tumor-derived extracellular vesicles and enveloped viruses from the bloodstream. The Company is advancing the Hemopurifier in oncology and life-threatening viral infections with the goal of improving outcomes for patients with limited treatment options. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially," or similar expressions constitute forward-looking statements. Such forward looking statements include but are not limited to statements regarding the completion and timing of enrollment in the third cohort of the Australian oncology feasibility study; the timing and results of the independent statistical analysis; whether the biological changes observed following Hemopurifier® treatment are reproducible or support a dose-response relationship; the potential safety, feasibility or biological activity of the Hemopurifier; the ability of the Hemopurifier to remove tumor-derived extracellular vesicles or otherwise modulate immune function; whether the biological changes observed will translate into meaningful clinical benefit or improved patient outcomes; the potential for the Hemopurifier to complement existing cancer therapies or improve responses to immunotherapy; the future development, regulatory progress, clinical evaluation, commercialization or market acceptance of the Hemopurifier; the potential applicability of the Hemopurifier in oncology, viral infections or other disease indications; and the Company's plans, expectations and objectives for future clinical studies and development activities.. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2026, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances. The clinical findings described herein are preliminary in nature, have not been subjected to formal statistical analysis, and may not be be replicated in subsequent clinical studies or trials. Company Contact: Jim Frakes Chief Executive Officer and Chief Financial Officer Aethlon Medical, Inc. [email protected] Investor Contact: Susan Noonan S.A. Noonan Communications, LLC [email protected] SOURCE Aethlon Medical, Inc. 21% more press release views with Request a Demo

氨基观察-创新药组原创出品 作者 | 沙晓威 日本医药巨头，在肿瘤领域持续刷新着行业认知。 前有第一三共的ADC改写全球肿瘤治疗格局，累积达成300亿美元的并购及商业化成就。后有安斯泰来依靠全球首款Nectin-4 ADC Padcev、CLDN18.2单抗Vyloy，定义着膀胱癌、胃癌靶向治疗标准。 2025财年，安斯泰来肿瘤收入规模达到87.8亿美元，手握Xtandi、Padcev、Vyloy等多款重磅肿瘤产品，一个肿瘤领域的全新巨头，雏形已现。 由于Xtandi专利悬崖近在眼前，安斯泰来已锁定五个具备重磅潜力的战略产品，其中肿瘤占3/5。这意味着，安斯泰来已经将肿瘤确立为公司最大的关注和投资领域，截至2026年5月，公司约四分之三的在研项目聚焦于肿瘤领域。 作为医药行业中吸金能力最强的板块，肿瘤市场始终吸引着全球的目光与竞争。人口尚不及中国十分之一的日本，在此领域持续进击，不断孕育出具有全球影响力的药企。作为全球第二大医药市场、坐拥全球最庞大肿瘤患者群体之一的中国，何时才能诞生属于自己的肿瘤巨头？ / 01 / 不容忽视的搅局者 一个必须承认的事实是，安斯泰来已经是肿瘤领域不可忽视的搅局者。 依托4款重磅肿瘤产品，安斯泰来在2025财年肿瘤收入规模达到87.8亿美元，稳居日本前五，全球前二十。其中，Xtandi销售额约60亿美元。 2027年前后，Xtandi将在美国市场面临仿制药的激烈竞争，专利悬崖面前，安斯泰来早已未雨绸缪，并在肿瘤领域打造起新的增长组合，试图接过Xtandi的大旗。 换句话说，不仅当前肿瘤收入规模居前，未来几年，安斯泰来肿瘤业务收入，增长潜力依然不容小觑。 Padcev的增长仍只是开始。依托EV-302等关键III期研究，Padcev联合Keytruda已经成为局部晚期及转移性尿路上皮癌一线标准治疗方案。此外，阿斯利康的Imfinzi，默沙东的Keytruda联合Padcev治疗围手术期膀胱癌的研究也在推进。 7月10日，FDA批准Padcev联合Keytruda用于接受根治性膀胱切除术的肌层浸润性膀胱癌患者的围手术期治疗，商业价值进一步提升。此前，安斯泰来，预计Padcev销售峰值将达27-33亿美元。 Vyloy所处的CLDN18.2领域，则代表安斯泰来另一条庞大增长曲线。 作为全球首款、也是目前唯一获批的CLDN18.2单抗，Vyloy率先验证了CLDN18.2这一新靶点的临床和商业价值，2025年，Vyloy销售额达到631亿日元（约4.2亿美元），同比增长415.6%，成为公司增长最快的肿瘤产品之一，预计销售峰值7-13亿美元。 安斯泰来还在不断巩固其在CLDN18.2赛道上的先发优势。在最新发布的企业战略规划（CSP2026）中，安斯泰来明确表示，将以Vyloy为基础，持续扩展CLDN18.2版图，覆盖不同治疗阶段、不同表达水平的胃癌或胃食管结合部癌患者。 除了持续推进Vyloy联合免疫治疗等新适应症开发，还通过BD不断补齐不同技术路线。2021年与Xencor合作开发CLDN18.2/CD3双抗ASP2138，随后又以最高13亿美元引进信诺维CLDN18.2 ADC XNW27011，进一步完善ADC布局。 基于CLDN18.2的布局，安斯泰来在胃癌、胰腺癌等高发癌种上持续发力。 除了实体瘤，安斯泰来也在血液瘤领域拥有商业化产品。FLT3抑制剂Xospata于2018年获批，用于复发/难治性FLT3突变AML，上市多年持续贡献稳定收入。2025年，Xospata销售额达到718亿日元（约4.78亿美元），同比增长5.7%。 从Padcev持续刷新膀胱癌治疗标准，到Vyloy打开CLDN18.2精准治疗时代，再到Xospata夯实血液瘤业务，这三款产品的销售峰值有望达到60亿美元，持续拉动安斯泰来的增长。 / 02 / 藏不住的野心 肿瘤是最有价值、最吸金的治疗领域，预计2030年所有产品的销售额将超过3700亿美元。 巨大的市场，吸引着无数药企前赴后继，安斯泰来的野心，也在不断强化。 过去几年，安斯泰来不断强化一个战略信号：肿瘤成为公司最大的关注和投资领域（Oncology is our largest area of focus and investment），将会是持续发力的方向。 基于这一战略，公司做了很充分的战略准备与调整。 首先，资源开始全面向肿瘤集中。 围绕这一目标，安斯泰来启动了覆盖2026—2030财年的成本优化计划，预计累计释放约2000亿日元（约13亿美元）资源。冈村直树特别强调，这项计划"并不仅仅是为了节约成本，也不是为了裁员"，释放出来的资金将继续投入研发，尤其是肿瘤业务，重点支持ADC、TCE、PROTAC、放射性药物等下一代技术平台。 其次，除了产品和管线，安斯泰来也在重新调整全球肿瘤业务的组织架构，为的是更适用于未来的增长。 作为公司最大的单一市场，美国贡献了安斯泰来约45%的全球营收，也是其肿瘤创新研发的核心基地。近年来，公司持续强化美国肿瘤团队建设，希望依托美国监管的灵活性，加快ADC、抗体的临床开发与商业化进程。 与此同时，安斯泰来希望铺开全球市场，其肿瘤业务在全球的布局也正在加速推进。 比如中国区，管理层曾公开表态，安斯泰来中长期目标是成为肿瘤专科领域头部品牌。同步落地北京创新研发中心，打通全球同步临床、同步上市机制，补齐新兴市场肿瘤商业化短板。对于胃癌、膀胱癌、前列腺癌等高发癌种，公司希望借助全球同步研发，加快创新产品在中国上市节奏，同时提升中国在全球研发体系中的战略价值。 从资源配置到市场规划，安斯泰来围绕肿瘤的战略思路已经非常清晰。如果顺利的话，这家日本药企，将在全球肿瘤领域，占据重要的一席之地。 / 03 / 期待中国药企跟上节奏 过去20多年，日本已经走出了武田制药、第一三共、安斯泰来等多家全球创新药巨头。它们的发展路径并不相同，但却拥有同样的特质：国际化。 国际化不止是拥有全球竞争实力的产品，更重要的是，拥有全球化的商业运营能力。早在上世纪末，武田、第一三共等企业便主动进入欧美市场，通过收购药企，设立海外研发中心、建立全球商业化团队，不断积累全球研发和商业化经验。 对于当时的日本药企来说，这同样意味着高投入、高风险。此前第一三共并购兰伯西也造成了巨大的打击。但它们敢于在全球市场中试错不断积累经验能力值得肯定。 除此之外，海外员工的加入也带来的新的思维方式。在武田、安斯泰来等企业的核心研发部门和高管中，都有很多海外背景的人才，从内到外的国际化是这些企业成长过程中始终坚持的发展战略。 虽然日本药企的路径，不能复制粘贴，但无论是研发能力还是临床推进速度，现阶段的中国创新药都不逊色于日本药企，成为巨头的前半程已经走通。与此同时，将产品推向全球市场的能力也在提升。 从仿制药到创新药出海，中国创新药的发展与日本药企有相似的轨迹。期待更多中国创新药企业，迈入更高阶段的国际化，掌握主导权。