AIM ImmunoTech Reports Positive Mid-year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer
AIM ImmunoTech (NYSE American: AIM) has reported positive mid-year data from its Phase 2 DURIPANC study, evaluating the combination of Ampligen® (rintatolimod) with AstraZeneca's Imfinzi® (durvalumab) for treating metastatic pancreatic cancer patients.
The study, conducted in collaboration with AstraZeneca and Erasmus Medical Center, has enrolled 14 out of 25 planned subjects. Key findings include: no significant toxicity, approximately 21% of patients showing PFS >6 months, and 64% of eligible patients achieving OS >6 months. The trial builds on previous successful results of Ampligen as a monotherapy in over 50 pancreatic cancer patients.
AIM has secured intellectual property protection through a U.S. patent extending to 2039 and orphan drug designations in both the U.S. and EU for Ampligen in pancreatic cancer treatment.
AIM ImmunoTech (NYSE American: AIM) ha riportato dati positivi a metà anno dal suo studio di Fase 2 DURIPANC, che valuta la combinazione di Ampligen® (rintatolimod) con Imfinzi® (durvalumab) di AstraZeneca per il trattamento di pazienti con cancro pancreatico metastatico.
Lo studio, condotto in collaborazione con AstraZeneca e l'Erasmus Medical Center, ha arruolato 14 su 25 soggetti previsti. I risultati principali includono: assenza di tossicità significativa, circa il 21% dei pazienti con PFS >6 mesi e il 64% dei pazienti idonei con OS >6 mesi. Il trial si basa su precedenti risultati positivi di Ampligen come monoterapia in oltre 50 pazienti con cancro pancreatico.
AIM ha ottenuto la protezione della proprietà intellettuale tramite un brevetto statunitense valido fino al 2039 e designazioni di farmaco orfano sia negli Stati Uniti che nell'UE per Ampligen nel trattamento del cancro pancreatico.
AIM ImmunoTech (NYSE American: AIM) ha informado datos positivos a mitad de año de su estudio de Fase 2 DURIPANC, que evalúa la combinación de Ampligen® (rintatolimod) con Imfinzi® (durvalumab) de AstraZeneca para el tratamiento de pacientes con cáncer pancreático metastásico.
El estudio, realizado en colaboración con AstraZeneca y el Erasmus Medical Center, ha inscrito a 14 de los 25 sujetos planificados. Los hallazgos clave incluyen: ausencia de toxicidad significativa, aproximadamente el 21% de los pacientes con PFS >6 meses y el 64% de los pacientes elegibles con OS >6 meses. El ensayo se basa en resultados previos exitosos de Ampligen como monoterapia en más de 50 pacientes con cáncer pancreático.
AIM ha asegurado la protección de la propiedad intelectual mediante una patente estadounidense que se extiende hasta 2039 y designaciones de medicamento huérfano tanto en EE. UU. como en la UE para Ampligen en el tratamiento del cáncer pancreático.
AIM ImmunoTech (NYSE American: AIM)은 전이성 췌장암 환자 치료를 위한 AstraZeneca의 Imfinzi® (durvalumab)와 Ampligen® (rintatolimod) 병용 요법을 평가하는 2상 DURIPANC 연구의 중간 긍정적 데이터를 발표했습니다.
이 연구는 AstraZeneca 및 Erasmus Medical Center와 협력하여 진행되었으며, 계획된 25명 중 14명이 등록되었습니다. 주요 결과는 유의한 독성 없음, 약 21%의 환자가 6개월 이상 무진행생존기간(PFS), 그리고 64%의 적격 환자가 6개월 이상 전체생존기간(OS)을 달성했다는 점입니다. 이 임상시험은 50명 이상의 췌장암 환자에서 Ampligen 단독요법으로 얻은 이전의 성공적인 결과를 기반으로 합니다.
AIM은 2039년까지 유효한 미국 특허와 췌장암 치료용 Ampligen에 대해 미국과 EU에서 희귀의약품 지정도 확보했습니다.
AIM ImmunoTech (NYSE American : AIM) a annoncé des données positives à mi-parcours de son étude de phase 2 DURIPANC, évaluant la combinaison de Ampligen® (rintatolimod) avec Imfinzi® (durvalumab) d'AstraZeneca pour le traitement des patients atteints d’un cancer du pancréas métastatique.
Cette étude, menée en collaboration avec AstraZeneca et le centre médical Erasmus, a inclus 14 des 25 sujets prévus. Les résultats clés comprennent : aucune toxicité significative, environ 21 % des patients avec une survie sans progression (PFS) > 6 mois, et 64 % des patients éligibles avec une survie globale (OS) > 6 mois. Cet essai s’appuie sur les résultats positifs antérieurs d’Ampligen en monothérapie chez plus de 50 patients atteints de cancer du pancréas.
AIM a obtenu une protection de la propriété intellectuelle grâce à un brevet américain valable jusqu’en 2039 ainsi que des désignations de médicament orphelin aux États-Unis et dans l’Union européenne pour Ampligen dans le traitement du cancer du pancréas.
AIM ImmunoTech (NYSE American: AIM) hat positive Halbjahresdaten aus seiner Phase-2-Studie DURIPANC veröffentlicht, in der die Kombination von Ampligen® (Rintatolimod) mit AstraZenecas Imfinzi® (Durvalumab) zur Behandlung von Patienten mit metastasiertem Bauchspeicheldrüsenkrebs untersucht wird.
Die Studie, die in Zusammenarbeit mit AstraZeneca und dem Erasmus Medical Center durchgeführt wird, hat 14 von 25 geplanten Probanden eingeschlossen. Wichtige Ergebnisse sind: keine signifikante Toxizität, etwa 21 % der Patienten mit einem progressionsfreien Überleben (PFS) von über 6 Monaten und 64 % der geeigneten Patienten mit einem Gesamtüberleben (OS) von über 6 Monaten. Die Studie baut auf früheren erfolgreichen Ergebnissen von Ampligen als Monotherapie bei über 50 Bauchspeicheldrüsenkrebspatienten auf.
AIM hat geistiges Eigentum durch ein US-Patent, das bis 2039 gilt, sowie Orphan-Drug-Designationen in den USA und der EU für Ampligen in der Behandlung von Bauchspeicheldrüsenkrebs gesichert.
- No significant toxicity observed in the combination therapy
- 21% of patients achieved PFS >6 months, with additional 21% not yet progressed
- 64% of eligible patients achieved OS >6 months, exceeding expectations
- Strong intellectual property protection with U.S. patent extending to 2039
- Secured orphan drug designations in both U.S. and EU markets
- Study is still in early phases with only 14 out of 25 planned subjects enrolled
- Full immune-monitoring data analysis is still pending
- Limited data set may not be representative of larger patient population
Insights
AIM's pancreatic cancer combination therapy shows promising interim data with favorable safety profile and survival metrics compared to historical treatments.
The interim results from AIM ImmunoTech's Phase 2 DURIPANC study represent a potentially significant development in pancreatic cancer treatment, one of the most challenging and lethal cancer types. The study combines Ampligen (rintatolimod), an innate immune activator, with Imfinzi (durvalumab), a PD-L1 checkpoint inhibitor from AstraZeneca.
The data from 14 enrolled subjects (out of a planned 25) shows three key findings that deserve attention: no significant toxicity in post-chemotherapy patients, ~21% of patients with progression-free survival exceeding 6 months (with another 21% not yet progressed), and overall survival beyond 6 months in 64% of eligible patients.
These results are particularly noteworthy because pancreatic cancer typically shows minimal response to immunotherapy approaches. The standard treatment pathway involving FOLFIRINOX chemotherapy often sees limited benefit from maintenance or second-line therapies. Historical data suggests that post-FOLFIRINOX maintenance therapy options have shown limited survival benefits.
The early safety profile is encouraging for a post-chemotherapy setting, which is typically challenging due to patient vulnerability after aggressive treatments like FOLFIRINOX. The progression-free survival and overall survival metrics, while preliminary, appear to outperform typical expectations for this disease stage.
This builds upon AIM's previous work with Ampligen as a monotherapy through a Compassionate Use Program at Erasmus Medical Center, which has already produced several peer-reviewed publications suggesting efficacy. The company has also secured patent protection for this combination therapy extending to 2039, plus orphan drug designations in both the US and EU, creating potential long-term commercial value if efficacy is confirmed.
Mid-year report of combination therapy demonstrates promising signs of both no significant toxicity and superior PFS and OS
OCALA, Fla., July 28, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported positive data in a mid-year update from 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 (the “DURIPANC” study) (See: ClinicalTrials.gov NCT05927142).
The DURIPANC study — which is a joint collaboration with AstraZeneca and Erasmus Medical Center (“Erasmus MC”) in the Netherlands — is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. A total of 14 subjects have been enrolled in DURIPANC as of the mid-year report. The primary objective of the study is the clinical benefit rate of the combination therapy; the secondary/exploratory objectives include assessing overall survival (OS), progression-free survival (PFS) and initiating immune-monitoring using available tissue biopsies and peripheral immune profiling.
Prof. Casper van Eijck, MD, PhD, of Erasmus MC, stated: “Our preliminary data suggests that the combination of Ampligen and durvalumab is well-tolerated in post-FOLFIRINOX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Immunologic correlatives and further follow-up are essential to determine the biological activity and the durability of response. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes.”
See: DURIPANC, Mid-Year Interim Clinical Progress Update.
Pancreatic cancer has limited immunotherapy responsiveness, particularly in unselected populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Compared to these data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS:
- No significant toxicity, an encouraging safety profile for a post-chemo setting;
- ~
21% of patients have PFS >6 months (3/14), with an additional21% not yet progressed; and - OS >6 months in the majority (
64% ) of eligible patients—better than expected in this setting.
AIM ImmunoTech CEO Thomas K. Equels stated: “Data from Ampligen as a maintenance monotherapy was extremely positive when compared to existing therapeutic approaches. DURIPANC builds on that foundation and these results suggest a clear path forward and identify a promising potential benefit of combining the selective innate immune activation of Ampligen with the checkpoint inhibition of durvalumab in pancreatic cancer maintenance therapy. I am hopeful that pending immune-monitoring data analysis by Prof. van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially groundbreaking clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need that kills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide.”
AIM’S Pancreatic Cancer Profile
The DURIPANC study is the culmination of several years of focus by AIM on the development of Ampligen for the treatment of pancreatic cancer. Since 2017, more than 50 pancreatic cancer patients received treatment with Ampligen as an immuno-oncology mono-therapy under a Dutch government-approved Compassionate Use/Early Access Program at Erasmus MC. Prof. van Eijck was the lead investigator and the EAP has produced a number of detailed analyses in both abstracts and peer-reviewed medical research publications:
- Rintatolimod (Ampligen®) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program
- Treating Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod: Hitting Two Targets with One Arrow?
- Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses
Based on these strong results suggesting Ampligen’s potential effectiveness as a pancreatic cancer monotherapy, in January 2023 the Company entered into Clinical Agreements with AstraZeneca and Erasmus MC for the investigator-initiated DURIPANC clinical trial to study the potential combination therapy of Ampligen and Durvalumab, a PD-L1 checkpoint inhibitor.
In order to protect what has the potential to be a valuable long-term benefit for stockholders, AIM has developed an intellectual property plan specific to pancreatic cancer that includes a recently issued U.S. patent for Ampligen as an oncology treatment in combination with an anti-PD-L1, extending protection to August 9, 2039, as well as orphan drug designations in pancreatic cancer in both the United States and the European Union granting years of market exclusivity to AIM for Ampligen post-commercial approval.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
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 the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy in pancreatic cancer. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com
FAQ
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