A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy and Safety of Ampligen in Combination With Standard of Care Versus SOC Alone Following First-Line Therapy in Subjects With Locally Advanced Pancreatic Adenocarcinoma

The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma

开始日期2026-06-01

申办/合作机构

AIM ImmunoTech, Inc.

[+1]

NCT04093323

/ Terminated临床2期IIT

A Phase II Study of Type-1 Polarized Dendritic Cell (aDC1) -Based Treatment in Combination With Tumor-Selective Chemokine Modulation (CKM: Interferon Alpha 2b, Rintatolimod and Celecoxib) in Melanoma Patients With Primary PD-1/PD-L1 Resistance

This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.

开始日期2024-11-13

申办/合作机构

Roswell Park Comprehensive Cancer Center

[+1]

NCT05756166

/ Terminated临床1/2期IIT

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.

开始日期2024-02-16

申办/合作机构

Roswell Park Comprehensive Cancer Center

[+1]

100 项与安普利近相关的临床结果

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100 项与安普利近相关的转化医学

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100 项与安普利近相关的专利（医药）

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项与安普利近相关的文献（医药）

2025-09-01·Journal for ImmunoTherapy of Cancer

Synergy between TLR3-ligand and IFN-α in the transient sensitization of “Cold” tumors to PD-1 blockade and the induction of systemic immunity

Article

作者: Wang, Jianmin ; Cortes-Gomez, Eduardo ; Obermajer, Natasa ; Kalinski, Pawel ; Kokolus, Kathleen M ; Connors, Eoghan L ; Huck, Connor J ; Basse, Per H

Background:

Programmed cell death protein-1 (PD-1)-blocking immune checkpoint inhibitors (ICIs) are effective against highly immunogenic “hot” tumors containing high numbers of cytotoxic T-lymphocytes (CTLs), but not against poorly immunogenic “cold” tumors. We previously reported that the combination of TLR3 agonist rintatolimod with interferon (IFN)-α selectively induces CTL-attracting chemokines (CXCL9, CXCL10, CCL5) in the tumor microenvironment (TME), but not healthy tissues, raising the possibility of their systemic application to promote local CTL attraction to TME.

Methods:

We used mouse colorectal cancer (CRC) cells implanted in syngeneic mice to test the effects of chemokine modulatory regimen (CKM) in combination with PD-1 blockade applied at different schedules. Tumor-bearing mice were treated and monitored for survival. In addition, we evaluated the reliance of CKM+αPD-1 treatment on various immune cell subsets. Finally, we observed treatment-induced changes in immune markers within TME.

Results:

Here, we report that both local or systemic application of CKM, a combination of rintatolimod and IFN-α, but not each of them individually, induces intratumoral CTL attractants and sensitizes PD-1-resistant MC38 and CT26 tumors to PD-1 blockade. The CKM/αPD-1 combination promotes intratumoral influx of BATF3-positive cDC1s and CTLs, inhibits tumor growth and prolongs survival, inducing cures in 20–100% of animals, depending on the tumor model and stage, and the route of delivery (local or systemic). CKM/αPD-1-treated mice develop local and systemic tumor-specific CTL responses and resistance to tumor re-challenge. The effectiveness of CKM requires its application at the time of or directly before PD-1 blockade and is strongly reduced by even a 24-hour delay in αPD-1 administration. CKM-driven intratumoral CTL accumulation and antitumor effects require host’s BATF3+cDC1s, CD8+T-lymphocytes, and CXCR3 and CCR5 (receptors for CXCL9/CXCL10 and CCL5).

Conclusions:

The ability of systemic CKM to eliminate the PD-1-resistance of cold tumors indicates that intratumoral CTL accumulation, rather than tumor immunogenicity, is the key factor limiting the therapeutic effectiveness of ICI. These data suggest a broad therapeutic potential of TME-reprogramming strategies.

2024-11-01·Journal for ImmunoTherapy of Cancer

Systemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer

Article

作者: O’Connor, Tracey ; Attwood, Kristopher ; Wang, Jianming ; Roudko, Vladimir ; Levine, Ellis G ; Slomba, Ronald T ; Gnjatic, Sacha ; Ioannou, Giorgio ; Cortes Gomez, Eduardo ; De Souza, Igor ; Cappuccino, Helen ; Kalathil, Suresh ; Fitzpatrick, Victoria ; Kumar, Prasanna ; Miller, Janine ; Janes, Cayla ; Ozbey, Sinem ; Kokolus, Kathleen M ; Takabe, Kazuaki ; Kalinski, Pawel ; Edge, Stephen ; Gandhi, Shipra ; Opyrchal, Mateusz ; Young, Jessica

Background:

Higher cytotoxic T lymphocyte (CTL) numbers in the tumor microenvironment (TME) predict pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) and positive long-term outcomes in triple-negative breast cancer (TNBC). pCR to NAC is achieved only in 30–40% of patients. The combination of NAC with pembrolizumab increases the pCR rate but at the cost of immune-related adverse events (irAEs). Based on these considerations, we tested if systemic infusion of the chemokine modulatory regimen (CKM; selective toll-like receptor 3 (TLR3) agonist rintatolimod, interferon (IFN)-α2b, and cyclooxygenase-2 (COX-2) inhibitor celecoxib) regimen can be safely combined with NAC to enhance intratumoral CTL numbers and NAC effectiveness.

Methods:

Phase I study NCT04081389 evaluated nine patients with early-stage TNBC who received 3 weeks of paclitaxel with CKM (dose-escalation of IFN-α2b), followed by 9 weeks of paclitaxel alone, dose-dense doxorubicin and cyclophosphamide, and surgery. Primary and secondary endpoints were safety and clinical efficacy, respectively.

Results:

The combination treatment was well-tolerated with no dose-limiting toxicities or irAEs. 5/9 patients achieved pCR and one patient had microinvasive disease (ypTmic). We observed elevated IFN signature and uniform decreases in CTL numbers (average 8.3-fold) in the blood of all treated patients. This was accompanied by reciprocal uniform increases in CD8β (overall 5.9-fold), CD8α/FoxP3 (2.11-fold), and CCL5 (4.73-fold) transcripts in TME, particularly pronounced in patients with pCR. Multiplex immunohistochemistry revealed selectively increased numbers of CTL (but not regulatory T cells) in both the epithelial and stromal tumor compartments and early decreases in the numbers of αSMA+ vascular/stromal cells in the tumors of all pCR patients.

Conclusions:

Combined paclitaxel/CKM regimen was safe, with desirable TME changes and preliminary indications of promising pCR+ypTmic of 66%, comparable to the combination of NAC with pembrolizumab.

2024-08-15·Clinical cancer research : an official journal of the American Association for Cancer Research

Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell–Mediated T-Cell Responses

Article

作者: van Eijck, Casper H.J. ; van Eijck, Casper W.F. ; Mustafa, Dana A.M. ; Aerts, Joachim G.J.V. ; Kucukcelebi, Songul ; Willemsen, Marcella ; Fellah, Amine ; Vadgama, Disha ; Haddaoui, Hassana el

Abstract:

Purpose::

Amid the need for new approaches to improve survival in pancreatic ductal adenocarcinoma (PDAC), immune-based therapies have garnered interest. Rintatolimod, a Toll-like receptor 3 (TLR-3) agonist, is a potential candidate due to its dual impact on restraining PDAC cell functions and boosting the antitumor immune response. This study investigates the effect of TLR-3 activation through rintatolimod on the peripheral immune landscape of patients with advanced PDAC.

Experimental Design::

Paired blood samples of 30 patients with advanced PDAC, collected at baseline and after 12 rintatolimod intravenous infusions, underwent comprehensive transcriptomic NanoString and proteomic flow cytometry profiling. The impact of rintatolimod and immunologic factors on survival outcomes was assessed through univariate Cox proportional hazards models.

Results::

Rintatolimod treatment enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1) and T cells. Post-rintatolimod, the increased peripheral abundance of BTLA+ XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronouncedDCand T-cell activation gene overexpression. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-rintatolimod across all patients. However, those with progressive disease showed increased expression of genes encoding IDO1 and PD-1.

Conclusions::

This study presents compelling evidence of the immune-stimulatory properties linked to TLR-3 activation through rintatolimod. Rintatolimod may break immunologic tolerance by enhancing antitumor immunity through DC-mediated Th-cell responses. Furthermore, our findings lay the groundwork for investigating the potential synergy between TLR-3 activation and immune checkpoint inhibitor therapy to improve therapeutic outcomes.See related commentary by Martínez-Riaño et al., p. 3355

180

项与安普利近相关的新闻（医药）

2026-02-25

·GlobeNewswire-Health Care

AIM ImmunoTech Announces Extension of Subscription Period of its Previously Announced Rights Offering to March 3, 2026

OCALA, Fla., Feb. 25, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) – AIM ImmunoTech Inc. (“AIM” or the “Company”), 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 – announced today that it has extended the subscription period of its previously announced rights offering until 5:00 p.m., Eastern Time, on Tuesday, March 3, 2026. The subscription period for the rights offering commenced on February 11, 2026. All holders of subscription rights that wish to subscribe to the rights offering must deliver a properly completed and signed subscription rights certificate, together with payment of the full subscription price for the units the holder wishes to purchase pursuant to both the basic subscription right and the over-subscription privilege, to Broadridge Corporate Issuer Solutions, LLC (the “Subscription Agent”), to be received before 5:00 p.m., Eastern Time, on March 3, 2026. The completed rights certificate and payment should be delivered to the Subscription Agent as follows: By UPS, FedEx or Courier:By USPS Service:Broadridge, Inc.Attn: BCIS IWS51 Mercedes WayEdgewood, NY 11717Broadridge, Inc.Attn: BCIS Re-Organization DepartmentP.O. Box 1342Brentwood, NY 11717-0718 The subscription rights are non-transferable and will only be exercisable during the subscription period. Once holders have exercised their subscription rights, such exercise may not be revoked, canceled, or changed, even if holders subsequently learn information about the Company or its business, financial position, results of operations or cash flows that is material or adverse or that the holders otherwise consider to be unfavorable. The Company may cancel, modify or amend the rights offering at any time and for any reason prior to the expiration of the subscription period. Subscription rights which are not exercised by the expiration date of the rights offering will expire and will have no value. AIM has engaged Maxim Group LLC as dealer-manager for the proposed rights offering. Questions about the rights offering or requests for copies of the final prospectus may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at syndicate@maximgrp.com or telephone at (212) 895-3745. The Company’s registration statement on Form S-1 (Registration No. 333-292085) was declared effective by the Securities and Exchange Commission (“SEC”) on February 10, 2026. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC's website at http://www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. This press release is not an offering and an offering can only be made by the prospectus and any prospectus supplements for the rights offering, which should be read carefully before making an investment decision. The Company's stockholders as of 5:00 p.m., Eastern Time, on February 10, 2026 – the record date – should make an independent investment decision about whether to exercise their subscription rights based on their own assessment of the Company's business, financial condition, prospects for the future and the terms of the rights offering. About AIM ImmunoTech 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. Forward Looking Statements Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in the press release speak only as of the date of the press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 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 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 animal models 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, 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 or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given 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. Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the registration statement. Its filings are available at www.aimimmuno.com. The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only. IR Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com

临床研究

2026-02-23

·BioSpace

AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and AstraZeneca’s Durvalumab in the Treatment of Metastatic Pancreatic Cancer

OCALA, Fla., Feb. 23, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced milestones in the expected timeline for the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen ® (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi ® (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the “DURIPANC” study) (see: ClinicalTrials.gov NCT05927142 ). DURIPANC is an investigator-initiated, exploratory, open-label, single-center study, and 18 subjects have enrolled in the study so far. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center (“Erasmus MC”) in the Netherlands. Planned DURIPANC milestones: July 2026 – Complete subject enrollment. August 2026 – Complete full Ampligen dosing for all subjects. December 2026 – Evaluation of the Primary Endpoint of Clinical Benefit Rate, defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy. June 2027 – Evaluation of the Secondary Endpoints once last subject reaches week 49 Progression-Free Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of progression or death, whichever occurs first. Overall Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of death, Immunogenic efficacy, defined as >50% increase in circulating Ki67+ CD 8+ T cell in peripheral blood evaluated 12 weeks after start of combination therapy. Infiltrating immune profile, defined as the change in infiltrating immune pro start of combination therapy. Reporting of Quality of life (EORTC QLQ-C30) based upon evaluations at baseline, 6 weeks, 3 months, 9 months and 1 year after the start of immunotherapy. AIM is committed to releasing mid-year and year-end interim progress reports on DURIPANC, with the most recent update released at the beginning of February. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study – which supported advancement to the ongoing Phase 2 portion of the study – continue to be seen and that enrollment is ongoing. Erasmus MC expects that detailed data will be published later this year. According to Erasmus MC, there has also been no significant toxicity – an encouraging safety pro a post-chemo setting – and Ampligen subjects are consistently reporting “high quality of life” during treatment. See : DURIPANC, Year-End Interim Clinical Progress Update Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company’s priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM’s research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM’s stockholders. The largest mergers and acquisitions deals in the biotech space often involve oncology drugs in Phase 3 clinical trials or later in development, and so AIM believes that moving Ampligen toward – and ultimately into – a Phase 3 clinical trial has great financial potential for the Company and its stockholders. See: Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer: Corporate Presentation – February 2026 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. Forward-Looking Statements Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in the press release speak only as of the date of the press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 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 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 animal models 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, 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 or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given 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. Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the Registration Statement. Its filings are available at The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only. CONTACT: Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com

临床2期免疫疗法并购临床3期

2026-02-14

·药明康德

口服GLP-1/GIP双重受体激动剂2期结果积极；治疗MASH，44亿美元合作助力RNAi药物开发…… | TIDES周报

近期，全球多肽和寡核苷酸（TIDES）领域迎来系列进展。恒瑞医药与Kailera Therapeutics公司共同宣布，口服胰高血糖素样肽‑1（GLP-1）和葡萄糖依赖性促胰岛素肽（GIP）双重受体激动剂瑞普泊肽片（ribupatide）在2期临床试验中取得积极结果。治疗第26周时，参与者较基线平均体重下降最高达12.1%。Madrigal Pharmaceuticals与瑞博生物达成研发合作，双方将基于瑞博生物的肝靶向RiboGalSTAR平台，联合开发6款针对代谢功能障碍相关脂肪性肝炎（MASH）的创新siRNA疗法。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。 26周减重最高达12.1%，口服GLP-1/GIP双重受体激动剂2期临床结果积极恒瑞医药与Kailera Therapeutics公司共同宣布，GLP-1和GIP双重受体激动剂——每日一次口服瑞普泊肽片（ribupatide，也称HRS9531片、KAI-9531-T），在中国166名肥胖成人中开展的2期临床试验取得积极顶线数据。基于疗效估计值（efficacy estimand）的分析结果显示，瑞普泊肽片治疗第26周时，参与者较基线平均体重下降最高达12.1%，且未观察到平台期，同时呕吐发生率不超过11.4%。瑞普泊肽是恒瑞医药研发的GLP-1/GIP双重受体激动剂，目前正在开发每周一次的皮下注射剂和每日一次的口服片剂，拟用于肥胖和超重治疗。2024年5月，恒瑞医药将包括瑞普泊肽在内的GLP-1类创新药组合在大中华区以外开发、生产和商业化的独家权利授予Kailera。Kailera目前正在开展KaiNETIC全球3期临床研究以评估瑞普泊肽注射液治疗肥胖症的疗效。基于令人鼓舞的临床数据，恒瑞医药将在中国推进瑞普泊肽片进入3期试验，Kailera计划于2026年启动瑞普泊肽片全球范围的2期试验。 44亿美元！Madrigal与瑞博生物合作开发针对MASH的siRNA疗法 Madrigal Pharmaceuticals是一家专注于为MASH开发创新疗法的生物医药公司。该公司宣布已与苏州瑞博生物技术股份有限公司（瑞博生物）及其子公司Ribocure Pharmaceuticals达成全球独家许可协议。双方将基于瑞博生物的肝靶向RiboGalSTAR平台，联合开发6款针对MASH的创新siRNA疗法。根据协议条款，瑞博生物将授予Madrigal多款MASH领域单靶点及双靶点临床前siRNA资产的全球独家研发、生产与商业化权利。瑞博生物将获得6000万美元首付款；在达成临床开发、监管审批及商业销售等一系列里程碑节点后，瑞博生物将有资格获得累计最高达44亿美元的款项（包含首付款和里程碑付款）。 siRNA通过选择性降低致病蛋白的生成，为MASH提供一种精准的基因沉默策略。当siRNA分子与GalNAc配体偶联后，可被直接递送至肝细胞，通过靶向降解mRNA来沉默已被确定为MASH关键风险因素的相关基因。通过将这种精准的基因沉默策略与获批MASH疗法Rezdiffra联用，Madrigal旨在探索在基因层面降低疾病驱动因素是否能够补充和增强Rezdiffra的治疗效果。首批候选项目的IND支持性研究计划将于2026年启动。礼来24亿美元收购环状RNA疗法新锐礼来（Eli Lilly and Company）与Orna Therapeutics宣布，礼来就收购Orna达成最终协议。Orna正在推进其细胞疗法平台，该平台基于工程化环状RNA，并结合新型脂质纳米颗粒，可使患者自身在体内生成具有治疗作用的免疫细胞，从而靶向疾病的根本机制。 Orna的主打项目为ORN-252，这是一款即将进入临床试验的体内CD19靶向嵌合抗原受体T细胞（CAR-T）疗法，拟用于治疗由B细胞驱动的自身免疫性疾病。现有研究结果显示，Orna的环状RNA平台有望实现更持久的治疗性蛋白表达。根据协议条款，礼来将完成对Orna的收购，Orna有望获得最高达24亿美元的款项，其中包括首付款以及在达成特定临床开发里程碑后支付的后续款项。治疗晚期胰腺癌，RNA疗法临床结果积极 AIM ImmunoTech在最新的年度更新中披露，其正在进行的2期临床研究DURIPANC取得积极数据。该研究评估了该公司旗下药物Ampligen（rintatolimod）联合PD-L1抑制剂Imfinzi（durvalumab），用于治疗在接受FOLFIRINOX标准治疗后病情稳定的转移性胰腺癌患者。DURIPANC研究是在此前一项包含57例受试者的早期使用项目（EAP）基础上开展的2期随访研究。在该EAP中，Ampligen作为单药用于晚期胰腺癌治疗，与标准治疗相比，将患者的中位总生存期延长8.6个月，延长至19.7个月，同时患者还报告生活质量有所改善。 DURIPANC研究为研究者发起的探索性、开放标签、单中心2期临床试验，计划最多入组25例受试者，目前已完成18例入组。该研究的次要及探索性终点包括总生存期（OS）和无进展生存期（PFS）的评估，并通过可获得的组织活检及外周免疫分析探索免疫学变化，同时评估患者生活质量。截至目前，研究过程中未观察到显著毒性反应，在化疗后治疗背景下显示出良好的安全性特征；同时，接受Ampligen治疗的患者在治疗期间持续报告较高的生活质量。 Ampligen是一种双链RNA分子，具有免疫调节和抗病毒特性。该药可作为Toll样受体3（TLR3）激动剂发挥作用，刺激干扰素和肿瘤坏死因子的产生，提高自然杀伤细胞功能。一体化平台赋能TIDES药物开发作为医药创新的赋能者，药明康德旗下WuXi TIDES平台为全球合作伙伴开发寡核苷酸、多肽药物及相关化学偶联物，提供高效、灵活和高质量解决方案。WuXi TIDES通过同一个平台提供覆盖药物发现、CMC开发和生产的全生命周期服务，进一步简化了TIDES药物的开发流程。平台提供化合物筛选和合成，新型单体、连接子和配体、寡核苷酸、多肽及复杂化学偶联物的工艺开发与任何规模的生产服务。除了化学合成，WuXi TIDES还提供包括脂质纳米颗粒（LNP）在内的各类注射剂型与灌装形式的制剂开发、生产、贴标和配送服务。一体化的分析方法开发、验证和测试平台，能够支持包括原料药及制剂，覆盖从药物发现到临床再到商业化阶段的TIDES药物开发需求。此外，全球申报法规事务药学团队在准备CMC申报资料以支持TIDES新药全球申报方面拥有丰富的经验。参考资料： [1] 歌礼选定口服胰淀素受体激动剂多肽ASC36进行临床开发. Retrieved February 13, 2026, from https://www.prnasia.com/story/522093-1.shtml [2] Kailera Therapeutics and Hengrui Pharma Report Positive Topline Data from Phase 2 Obesity Trial of Oral Ribupatide. Retrieved February 13, 2026, from https://www.globenewswire.com/news-release/2026/02/10/3235172/0/en/Kailera-Therapeutics-and-Hengrui-Pharma-Report-Positive-Topline-Data-from-Phase-2-Obesity-Trial-of-Oral-Ribupatide.html [3] Stoke Therapeutics Announces First Patient Dosed in Phase 1 Study of STK-002, a Potential Disease-Modifying Medicine for the Treatment of Autosomal Dominant Optic Atrophy (ADOA). Retrieved February 13, 2026, from https://investor.stoketherapeutics.com/news-releases/news-release-details/stoke-therapeutics-announces-first-patient-dosed-phase-1-study [4] 瑞博生物与Madrigal达成44亿美元全球独家许可协议，携手开发MASH创新siRNA疗法. Retrieved February 13, 2026, from https://www.prnasia.com/story/522196-1.shtml [5] Aerska Raises $39M Series A Financing led by EQT Dementia Fund and age1 to Systemically Deliver RNA Medicines to the Brain. Retrieved February 13, 2026, from https://www.globenewswire.com/news-release/2026/02/09/3234456/0/en/Aerska-Raises-39M-Series-A-Financing-led-by-EQT-Dementia-Fund-and-age1-to-Systemically-Deliver-RNA-Medicines-to-the-Brain.html [6] Lilly to acquire Orna Therapeutics to advance cell therapies. Retrieved February 9, 2026 from https://www.prnewswire.com/news-releases/lilly-to-acquire-orna-therapeutics-to-advance-cell-therapies-302682157.html [7] AIM ImmunoTech Reports Positive Year-End Interim Clinical Progress from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer. Retrieved February 5, 2026 from https://www.globenewswire.com/news-release/2026/02/05/3233016/0/en/AIM-ImmunoTech-Reports-Positive-Year-End-Interim-Clinical-Progress-from-Phase-2-Study-Evaluating-Ampligen-rintatolimod-in-Combination-with-AstraZeneca-s-Imfinzi-durvalumab-for-the-.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

siRNA引进/卖出临床2期临床3期寡核苷酸

100 项与安普利近相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09661	安普利近	L03A	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性疲劳综合征	阿根廷	AIM ImmunoTech, Inc.	2017-01-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期胰腺腺癌	临床2期	美国	AIM ImmunoTech, Inc.	2025-01-01
局部晚期胰腺腺癌	临床2期	荷兰	AIM ImmunoTech, Inc.	2025-01-01
转移性胰腺癌	临床2期	荷兰	AstraZeneca PLC	2024-01-09
转移性胰腺癌	临床2期	荷兰	AIM ImmunoTech, Inc.	2024-01-09
转移性胰腺导管腺癌	临床2期	荷兰	AstraZeneca PLC	2024-01-09
转移性胰腺导管腺癌	临床2期	荷兰	AIM ImmunoTech, Inc.	2024-01-09
新冠肺炎后遗症	临床2期	美国	AIM ImmunoTech, Inc.	2023-06-30
结直肠癌	临床2期	-	AIM ImmunoTech, Inc.	2022-04-11
急性白血病	临床2期	美国	Roswell Park Comprehensive Cancer Center	2020-11-17
急性白血病	临床2期	美国	AIM ImmunoTech, Inc.	2020-11-17

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04093323 (CTgov)	临床2期	难治性黑色素瘤	1	Alpha-type-1 Polarized Dendritic Cells+Intron A+Heberon Alfa+Urifron+Rintatolimod+celecoxib	築積憲網網醖糧壓淵膚(簾壓糧觸糧顧壓獵簾觸) = 鹽衊糧膚餘顧繭憲衊簾醖襯選網鏇襯蓋蓋艱簾 (鹹壓網鬱選鬱鹽廠鹽壓, 廠膚醖繭願鏇鹹壓積鬱 ~ 憲衊衊壓艱壓壓繭蓋鹹) 更多	-	2026-02-25
NCT04379518 (CTgov)	临床1/2期	新型冠状病毒感染 \| 慢性淋巴细胞白血病 \| 恶性实体肿瘤 ... 更多	4	Recombinant Interferon Alfa-2b+Rintatolimod (1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2)	鑰鑰窪餘壓顧構簾餘築 = 鑰衊醖鬱夢淵顧獵繭齋壓憲鬱選夢淵淵夢網醖 (膚構鏇醖積糧積膚範遞, 夢簾構獵鏇願醖鬱壓築 ~ 鹽窪醖願夢鹹獵構壓鏇) 更多	-	2026-01-13
NCT04379518 (CTgov)	临床1/2期	新型冠状病毒感染 \| 慢性淋巴细胞白血病 \| 恶性实体肿瘤 ... 更多	4	Recombinant Interferon Alfa-2b+Rintatolimod (2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2)	選簾鹽製蓋簾衊膚糧廠(糧醖襯構簾窪顧鑰壓繭) = 觸衊鏇構構鹽艱製繭廠齋齋網鬱廠壓齋網顧衊 (襯顧選製衊壓糧糧願鹹, 簾糧選鹽夢壓觸構廠艱 ~ 遞襯廠簾觸蓋糧壓艱醖) 更多	-	2026-01-13
NCT03734692 (SITC2025) 人工标引	临床2期	铂敏感性卵巢癌	24	IP cisplatin + IV Pembrolizumab + IP TLR3 ligand Rintatolimod	襯憲鹽衊觸糧齋鏇廠窪(積醖糧簾糧夢齋選選蓋) = 鹽鹹餘獵範壓醖壓艱積餘淵淵鏇膚壓鹽構範鏇 (繭製鬱鹹繭廠憲艱鑰鹹 ) 更多	积极	2025-11-07
NCT05927142 (DURIPANC, GlobeNewswire) 人工标引	临床2期	转移性胰腺癌	14	rintatolimod + durvalumab	獵膚膚廠醖淵製鬱鹽齋(齋窪醖鹹鬱憲製範鏇選) = 願積構遞顧齋築憲壓膚遞範憲膚遞廠夢鬱網遞 (願鏇築憲網構餘夢願膚 ) 更多	积极	2025-07-28
NCT03734692 (CTgov)	临床1/2期	复发性卵巢癌	24	cisplatin+Rintatolimod+Pembrolizumab	廠艱醖鑰觸鹽繭窪繭選 = 觸構衊鏇膚壓選製夢淵顧鏇構願顧膚積餘構醖 (選艱鑰衊襯築製鏇選憲, 蓋願憲獵醖鹹願廠壓齋 ~ 鹹壓簾積鑰壓範醖憲範) 更多	-	2025-07-20
NCT05592418 (AMP-518, CTgov)	临床2期	新冠肺炎后遗症	80	Rintatolimod (Ampligen / Rintatolimod)	衊積顧艱簾憲積願廠築(廠襯構網製廠膚遞遞獵) = 顧蓋鬱鏇鹽齋鹽淵鹽願蓋夢糧糧艱網鏇獵膚壓 (製網廠膚繭鑰壓積簾獵, 9.31) 更多	-	2025-01-22
NCT05592418 (AMP-518, CTgov)	临床2期	新冠肺炎后遗症	80	Placebo / Normal Saline (Placebo / Saline)	衊積顧艱簾憲積願廠築(廠襯構網製廠膚遞遞獵) = 膚構齋製繭積遞鹹簾簾蓋夢糧糧艱網鏇獵膚壓 (製網廠膚繭鑰壓積簾獵, 7.51) 更多	-	2025-01-22
NCT05927142 (DURIPANC, NEWS 1 \| NEWS 2)	临床1/2期	转移性胰腺癌	-	度伐利尤单抗+Rintatolimod	鬱鹹獵築餘網鹹選構鹽(網憲糧簾夢鑰獵鹹範壓) = 醖齋廠範窪鹹構顧觸餘衊願窪齋淵鬱鑰遞選齋 (糧觸餘網膚鬱觸鹽網餘 )	积极	2024-04-29
NCT05592418 (AMP-518, Corporate Publications) 人工标引	临床2期	新冠肺炎后遗症	66	Ampligen	鬱鬱鹹繭願鏇鹹選壓鹹(積製繭製餘觸衊鹽選壓) = between the Ampligen and placebo groups reached or approached statistical significance at several timepoints during the treatment phase. 鑰鹹淵壓壓構顧衊衊糧 (壓蓋觸齋憲簾艱築醖憲 ) 更多	积极	2024-02-08
NCT05592418 (AMP-518, Corporate Publications) 人工标引	临床2期	新冠肺炎后遗症	66	Placebo		积极	2024-02-08
NCT03734692 (GlobeNewswire) 人工标引	临床2期	复发性卵巢癌	-	Ampligen+pembrolizumab	窪壓壓廠製蓋顧網夢淵(製願襯獵窪衊蓋積襯選) = Longitudinal comparison of biomarkers in tumor microenvironment showed a gradual, durable response over time in T lymphotactic CXCR3 ligands and cytolytic factors 顧築遞製觸壓醖餘顧繭 (繭觸鏇鬱範窪齋餘窪簾 )	积极	2023-11-08
NCT04081389 (Phase I study, CTgov)	临床1期	三阴性乳腺癌 \| 早期乳腺癌	9	Interferon Alpha-2b (Arm 1: Interferon Alpha-2b at DL 1)	觸鬱構壓窪鹽製餘膚淵 = 糧選膚繭鏇鬱糧選衊夢遞築壓憲醖衊憲構壓壓 (廠憲願網構鏇憲觸獵蓋, 艱範壓壓構醖獵觸襯鑰 ~ 窪積繭鏇獵願選鑰蓋顧) 更多	-	2023-09-11
NCT04081389 (Phase I study, CTgov)	临床1期	三阴性乳腺癌 \| 早期乳腺癌	9	Interferon Alpha-2b (Arm 2: Interferon Alpha-2b at DL 2)	觸鬱構壓窪鹽製餘膚淵 = 憲構顧糧網窪蓋積範襯遞築壓憲醖衊憲構壓壓 (廠憲願網構鏇憲觸獵蓋, 觸獵繭製鏇獵鏇艱廠構 ~ 鏇觸淵餘鹹鏇鏇醖齋願) 更多	-	2023-09-11