Rintatolimod

一、摘要过去两周，全球肿瘤研发的一个清晰信号是：行业正在从“占位”转向“递送后再处理”，从单纯阻断靶点转向更高精度的细胞内干预与多靶点协同。最具代表性的事件是强生宣布以 10 亿美元现金收购 Firefly Bio，押注其 Firelink degrader antibody conjugate（DAC）平台；与此同时，Zai Lab 的 DLL3 靶向 ADC 获得 EMA 孤儿药认定，NovaBridge 的 givastomig 获得 FDA 快速通道相关进展，Lyell 的 LYL273 则在安全性管理上出现可量化改善。[finance.yahoo]但这轮变化并不意味着“机制升级”已经自动转化为临床胜利。当前这些项目大多仍处在早期到中早期阶段，真正决定价值的不是概念是否新，而是 OS/PFS 是否成立、毒性窗口是否足够宽、耐药是否会迅速回流、以及 payer 是否愿意为复杂生物制剂买单。[benzinga]二、核心事件1）强生收购 Firefly Bio：DAC 进入大药企资产池强生已宣布以 10 亿美元现金收购 Firefly Bio，目标是其 Firelink degrader antibody conjugate 平台，该平台面向 KRAS 驱动肿瘤。[wtvbam]这不是一次普通平台收购，而是大型药企对“抗体递送 + 细胞内降解”这一新型药物形态的明确下注。[unibestpharm]2）Zai Lab：ZL-1310 / zoci 获 EMA 孤儿药认定Zai Lab 宣布其 DLL3 靶向 ADC zocilurtatug pelitecan（zoci，原 ZL-1310）获得 EMA 孤儿药认定，适应症为 pulmonary neuroendocrine carcinomas。[1stoncology]这类监管认可的含义更多在于开发激励与路径信号，而不是疗效已被终局验证。[gurufocus]3）NovaBridge / ABL Bio：givastomig 获 FDA 快速通道相关进展公开报道显示，givastomig（ABL111）在 HER2 阴性、CLDN18.2 阳性、PD-L1 相关的胃癌方向获得 FDA 快速通道层面的积极反馈，并计划推进注册性研究。[biz.chosun]这说明 CLDN18.2 赛道仍在继续拥挤化，但真正的分化点已从“是否能打中靶点”转向“是否能在一线组合里拿到足够大的临床与商业增量”。[linkedin]4）Lyell LYL273：安全性优化显著Lyell 披露，针对复发/难治性转移性结直肠癌的 LYL273 在引入胃肠道预防方案后，2 级或更高等级腹泻/结肠炎发生率从 55% 降至 10%，并据此将研究修订为 Phase 1⁄2 设计。[globenewswire]这是一条重要的安全性信号，但它仍然主要证明的是 毒性管理可行，不是疗效已成熟。[stocktitan]三、技术机理Firelink DAC 的核心逻辑，是把 ADC 的肿瘤定向递送能力，与 degrader 的胞内蛋白降解能力结合起来，试图把“不可药化”靶点重新拉回可开发区间。[pulse2]如果这一方向成立，它的价值不只是“更强杀伤”，而是可能改变过去小分子抑制剂在部分驱动基因肿瘤中的耐药格局；但这一点仍需要后续临床数据验证，不能仅凭概念成立。[pulse2]MVB-101 这类 PSMA x FRα 多价设计的逻辑，是通过双抗原识别提高肿瘤选择性与结合稳定性；它在理论上有利于提升 avidity，但也会引入适应症筛选、抗原异质性和表达阈值的问题。[biospace]换句话说，多价不等于更稳，只有在肿瘤抗原分布足够一致时，这种设计才可能真正带来治疗窗改善。[medcitynews]Givastomig 这类 CLDN18.2 x 4-1BB 双特异分子，真正赌的是“靶向定位 + T 细胞共刺激”能否在冷肿瘤中创造比单纯 IO 更深的免疫激活；但它同样面临经典问题：肿瘤异质性、T 细胞耗竭、以及 4-1BB 相关安全性约束。[biz.chosun]四、临床信号Ono 的 Opdivo + Lenvima 在不可切除间变性甲状腺癌方向达到 ORR 终点的说法，当前更适合作为“项目进展信号”而非“临床定论”，因为公开可核验材料仍不足以支持完整的 OS/PFS、DoR 和安全性成熟结论。[未充分证实]AIM ImmunoTech 的 Ampligen + Imfinzi 在转移性胰腺癌中的中期进展，也属于早期探索性信号，当前更像是在验证 TLR3 激动剂是否能把冷肿瘤微环境推向可应答状态，而不是已经证明了生存获益。[未充分证实]对 Lyell 而言，最重要的并不是它是否“讲出一个更好听的 CAR-T 故事”，而是它通过预防方案把严重胃肠道毒性压低，这意味着 靶点可及性与临床可操作性之间的张力被暂时缓解。[benzinga]不过，GCC 相关靶向在正常肠道组织中的表达仍然构成根本性风险，长线商业化能否成立，最终取决于疗效是否足以覆盖毒性和制造复杂度。[stocktitan]五、研发与商业含义这几条新闻合在一起，说明大药企和新创公司正在向三个方向集中：更复杂的递送系统、更强的多靶点选择性，以及更精细的安全性工程。[finance.yahoo]但资本市场真正会买单的，不是“分子形式更先进”，而是它是否能在竞争拥挤的赛道里形成可持续优势，尤其是在 OS、PFS2、耐药演化和 payer 报销逻辑上拿出硬证据。[linkedin]在这个框架下，ZL-1310 的价值更多在于 DLL3 赛道和孤儿药路径的开发红利；givastomig 的价值在于 CLDN18.2 一线组合的前置卡位；Firefly 的价值则是平台性，而不是单一适应症资产。[finance.yahoo]相反，如果后续临床只给出 ORR 或早期安全性优化，而缺乏 OS/PFS 与耐药控制数据，那么这些项目仍可能迅速回到“早期高估值、后期兑现不足”的老路径。[finance.yahoo]六、风险判断DAC 平台的核心风险在于：体内稳定性、非靶向组织暴露、以及降解剂 payload 的安全边界。[unibestpharm]多价偶联药的核心风险在于：抗原表达不均一会让所谓 avidity 在真实世界里打折，患者分群越窄，商业天花板越容易受限。[biospace]对于 CLDN18.2 这类拥挤靶点，最大风险不是“有没有药”，而是谁能在一线序列中证明更好的长期获益、可接受的毒性、以及足够低的拒付概率。[finance.yahoo]对于 CAR-T / 细胞疗法，最大风险则仍然是组织毒性、制造复杂度和给药链路，不是单次响应率本身。[benzinga]七、结论这期肿瘤学最重要的变化，不是又出现了一个新靶点，而是行业正在更明确地进入一个阶段：分子创新必须同时接受生物学、临床和支付三重审判。[finance.yahoo]谁能把“递送、选择性、耐药控制和制造可行性”同时做对，谁才可能从概念资产变成真正的治疗路径重构者。[unibestpharm]

Recent Clinical Progress, Enrollment Achievements, Expanded Intellectual Property Portfolio and Strengthened Financial Position Support a Potentially Transformative 12-Month Value Creation Opportunity OCALA, Fla., June 24, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today highlighted the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones that position the Company for what management believes could be a pivotal period in its evolution as a clinical-stage oncology company. At the center of AIM's strategy is Ampligen ® (rintatolimod), the Company's proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca's PD-L1 inhibitor Imfinzi ® (durvalumab) for the treatment of metastatic pancreatic cancer. Pancreatic cancer remains one of the deadliest forms of cancer worldwide, with limited treatment options and an urgent need for innovative therapies capable of extending survival and improving quality of life. AIM believes Ampligen's unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease. Execution Continues to Drive Momentum Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development: Completed Phase 2 DURIPANC enrollment ahead of schedule Achieved the important clinical milestone of dosing the final patient in the study Reported positive interim clinical updates from the ongoing trial Continued to demonstrate a favorable safety pro no significant toxicity reported in study updates Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations Maintained orphan drug designation for pancreatic cancer in major markets Regained compliance with NYSE American continued listing standards Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities These accomplishments represent important de-risking events that management believes support the advancement of Ampligen toward a potential registration-directed development pathway. Growing Clinical Foundation Supports Advancement Ampligen's pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations. Recent interim updates from DURIPANC have continued to support management's confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition. Importantly, the combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment. Multiple Near-Term Catalysts Ahead With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company's recent history. Key anticipated milestones include: Additional clinical updates from the ongoing DURIPANC study Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027 Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027 Continued immune monitoring and biomarker analyses Regulatory interactions supporting future development planning Further expansion of the Company's global intellectual property portfolio Advancement of Phase 3 planning activities Potential design and initiation activities associated with a registration-focused pivotal study Management believes each of these milestones has the potential to further validate Ampligen's clinical pro strengthen the Company's strategic position. A Clear Focus on Shareholder Value Creation AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value. The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority. As the biotechnology sector continues to place significant value on late-stage oncology assets, AIM believes successful execution of its pancreatic cancer strategy could substantially enhance the value of the Ampligen franchise. With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period. "We have built meaningful momentum across every aspect of the Ampligen pancreatic cancer program," said Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. "Our focus remains clear: facilitate the DURIPANC study, continue generating meaningful clinical data, advance regulatory planning, and position Ampligen for a potential pivotal development pathway. We believe these efforts have the potential to unlock significant value for patients, partners and our stockholders." As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment today. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen ® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials. For more information, please visit aimimmuno.com and connect with the Company on X , LinkedIn , and Facebook . Cautionary Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor created by those sections. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “believes,” “expects,” “intends,” “may,” “will,” “plans,” “potential,” “anticipates,” “projects,” or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, but the absence of these words does not mean that a statement is not forward-looking. Any forward-looking statements set forth in this press release speak only as of the date hereof. These forward-looking statements are based upon the Company’s current expectations, estimates, assumptions, and beliefs concerning future events and conditions, which are subject to change. Such forward-looking statements may include statements relating to: the timing of evaluation of the DURIPANC study’s primary endpoint; the Clinical Benefit Rate; the anticipated survival outcomes, quality-of-life measures, and the safety pro subjects and the expected timing thereof; the Company’s Phase 3 clinical trial planning efforts; the potential advancement of Ampligen toward pivotal-stage development; the timing of commencement, enrollment, completion, and results of clinical trials; IP expansion and regulatory progress; and timing for receiving government approvals, if at all. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof, except as required by applicable law. The Company is in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders, and disclosures in the Company’s reports filed with the U.S. Securities and Exchange Commission (the “SEC”), on its website, and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen ® will be effective in the treatment of these conditions. Results obtained in preclinical studies do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen ® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data, and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, lack of adequate funding, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data. No assurance can be given that the findings in preliminary studies will prove true or that such studies will yield favorable results, or that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website, and in its press releases. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks. For a detailed discussion of risk factors that could cause actual results to differ materially from those described in the forward-looking statements, please review the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC. The forward-looking statements in this press release should be read in conjunction with such filings. These filings are available at and The information found on the Company’s website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com