AIM ImmunoTech Highlights Growing Body of Compelling Data of Ampligen for the Treatment of Pancreatic Cancer at Conference in Poland
AIM ImmunoTech (NYSE American: AIM) presented the latest progress of its lead drug candidate Ampligen for pancreatic cancer treatment at the 5th Annual Marie Skłodowska-Curie Symposium in Poland. The presentation highlighted positive data from both the Phase 2 DURIPANC clinical trial and an Early Access Program, focusing on Progression-Free Survival and Overall Survival metrics.
The company's ongoing Phase 2 DURIPANC study evaluates Ampligen in combination with AstraZeneca's durvalumab for treating late-stage metastatic pancreatic cancer. Notably, Ampligen has secured patent protection through 2039 and holds both US and EU orphan drug designations for market protection upon approval.
AIM ImmunoTech (NYSE American: AIM) ha presentato gli ultimi sviluppi del suo principale candidato terapeutico, Ampligen, per il trattamento del cancro del pancreas al 5º Simposio annuale Marie Skłodowska-Curie in Polonia. La presentazione ha evidenziato dati positivi sia dallo studio clinico di Fase 2 DURIPANC sia da un Programma di Accesso Precoce, concentrandosi sulle misure di Survivenza Libera da Progressione e Survivenza Globale.
Lo studio in corso di Fase 2 DURIPANC valuta Ampligen in combinazione con durvalumab di AstraZeneca per il trattamento del cancro pancreatico metastatico in fase avanzata. È importante notare che Ampligen è protetto da brevetto fino al 2039 e ha ottenuto le designazioni di farmaco orfano negli USA e nell'UE, offrendo protezione di mercato in caso di approvazione.
AIM ImmunoTech (NYSE American: AIM) presentó los últimos avances de su principal candidato farmacológico, Ampligen, para el tratamiento del cáncer de páncreas en el 5.º Simposio Anual Marie Skłodowska-Curie en Polonia. La presentación destacó datos positivos tanto del ensayo clínico de Fase 2 DURIPANC como de un Programa de Acceso Temprano, centrados en las métricas de Supervivencia Libre de Progresión y Supervivencia Global.
El estudio en curso de Fase 2 DURIPANC evalúa Ampligen en combinación con durvalumab de AstraZeneca para el tratamiento del cáncer de páncreas metastásico en estadio avanzado. Cabe destacar que Ampligen cuenta con protección por patente hasta 2039 y tiene designaciones de medicamento huérfano en EE. UU. y la UE, lo que aporta protección de mercado en caso de aprobación.
AIM ImmunoTech (NYSE American: AIM)는 폴란드에서 열린 제5회 Marie Skłodowska-Curie 심포지엄에서 췌장암 치료를 위한 주요 후보 약물인 Ampligen의 최신 진행 상황을 발표했습니다. 발표에서는 2상 DURIPANC 임상시험과 조기 접근 프로그램(Early Access Program) 양쪽에서 나온 긍정적 데이터를 강조했으며, 무진행생존기간(PFS) 및 전체생존기간(OS) 지표에 중점을 뒀습니다.
진행 중인 2상 DURIPANC 연구는 말기 전이성 췌장암 치료를 위해 AstraZeneca의 durvalumab과의 병용으로 Ampligen을 평가하고 있습니다. 특히 Ampligen은 2039년까지 특허 보호를 확보했으며, 승인 시 시장 보호를 위한 미국 및 EU의 희귀의약품 지정도 보유하고 있습니다.
AIM ImmunoTech (NYSE American: AIM) a présenté les derniers progrès de son principal candidat-médicament, Ampligen, pour le traitement du cancer du pancréas lors du 5e Symposium annuel Marie Skłodowska-Curie en Pologne. La présentation a mis en avant des données positives provenant à la fois de l'essai clinique de phase 2 DURIPANC et d'un programme d'accès anticipé, en se concentrant sur les indicateurs de survie sans progression et de survie globale.
L'étude de phase 2 en cours, DURIPANC, évalue Ampligen en combinaison avec durvalumab d'AstraZeneca pour le traitement du cancer du pancréas métastatique avancé. Il est notable qu'Ampligen bénéficie d'une protection par brevet jusqu'en 2039 et dispose des désignations de médicament orphelin aux États-Unis et dans l'UE, offrant une protection du marché en cas d'approbation.
AIM ImmunoTech (NYSE American: AIM) stellte beim 5. jährlichen Marie Skłodowska-Curie-Symposium in Polen die neuesten Fortschritte seines führenden Wirkstoffkandidaten Ampligen zur Behandlung von Bauchspeicheldrüsenkrebs vor. Die Präsentation hob positive Daten sowohl aus der Phase-2-Studie DURIPANC als auch aus einem Early-Access-Programm hervor und konzentrierte sich auf die Kennzahlen progressionsfreies Überleben und Gesamtüberleben.
Die laufende Phase-2-Studie DURIPANC untersucht Ampligen in Kombination mit AstraZenecas durvalumab zur Behandlung von fortgeschrittenem metastasiertem Bauchspeicheldrüsenkrebs. Bemerkenswert ist, dass Ampligen Patentschutz bis 2039 besitzt und sowohl in den USA als auch in der EU die Orphan-Drug-Status hat, was bei Zulassung Marktschutz bietet.
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Insights
AIM's Ampligen shows promising survival data in pancreatic cancer trials, addressing a high-mortality disease with few effective treatments.
This press release highlights potentially significant clinical progress for AIM ImmunoTech's lead drug candidate Ampligen in the treatment of pancreatic cancer, one of the most lethal and treatment-resistant malignancies. The company presented data from both an Early Access Program and their ongoing Phase 2 DURIPANC trial at a cancer symposium in Poland.
The most meaningful aspect of this announcement is the claimed improvements in Progression-Free Survival (PFS) and Overall Survival (OS) - the two critical endpoints regulatory agencies require for cancer drug approvals. While specific numerical data wasn't provided in this release, the CEO's characterization of these results as "positive" suggests meaningful clinical benefit.
Particularly noteworthy is the trial's design combining Ampligen with durvalumab, AstraZeneca's PD-L1 inhibitor. This combination approach targeting both innate and adaptive immunity represents the current frontier in immunotherapy, especially important for pancreatic cancer which historically responds poorly to checkpoint inhibitors alone. The company has secured patent protection for this combination through 2039, providing substantial commercial runway if approved.
The orphan drug designations mentioned for both US and EU markets are significant regulatory advantages that would provide market exclusivity (7 years US/10 years EU) and potentially expedited review pathways. For a small biotech like AIM, these designations substantially enhance the commercial viability of their candidate.
Pancreatic cancer's dismal survival rates and limited treatment options make any promising data in this field potentially transformative. However, investors should note this remains a Phase 2 trial - still requiring larger Phase 3 studies before potential approval. The lack of specific efficacy numbers in this release also warrants caution when assessing clinical significance versus statistical significance.
Latest progress from lead program Ampligen for the treatment of pancreatic cancer highlighted at the International 5th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care (MSCI MSCS-2025); Presentation now available here
Ampligen has demonstrated data-driven promise in Progression-Free Survival and Overall Survival in both the DURIPANC clinical trial and an Early Access Program
OCALA, Fla., Sept. 04, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the presentation on the latest positive progress from its Ampligen clinical program in pancreatic cancer at the 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care hosted by and at Poland’s National Institute of Oncology in Warsaw, Poland.
AIM CEO Thomas K. Equels provided an overview of data from AIM’s pancreatic cancer Early Access Program and the latest advancements in the Phase 2 DURIPANC pancreatic cancer clinical trial currently underway at Erasmus University Medical Center in the Netherlands. The slides accompanying the presentation are now available on the Company’s website.
“Ampligen continues to demonstrate its potential for the treatment of late-stage metastatic and locally advanced pancreatic cancer. Our growing body of positive data continues to bolster our confidence. This lethal malignancy is a high unmet need. In particular, the Progression-Free Survival and Overall Survival – which are the gold standards for drug approval – seen in the clinical data demonstrated to date underscore our strong belief in the potential,” AIM ImmunoTech CEO Thomas K. Equels stated. “I am pleased to be a part of this gathering of global regulatory leaders, world-renowned oncologists and biopharma industry to share this important progress with Ampligen and highlight its potential in late-stage pancreatic cancer. We look forward to advancing its development and remain committed to bringing it to patients in desperate need and without real hope.”
AIM’s drug Ampligen is currently being tested in an ongoing Phase 2 DURIPANC clinical study evaluating the combination therapy of Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor durvalumab in the treatment of late-stage metastatic pancreatic cancer patients (See: ClinicalTrials.gov NCT05927142). Ampligen has patent protection for such a combination therapy in the United States through 2039, and US and EU orphan drug designations that will grant market protections for an approved drug.
For more information on Ampligen and to stay up to date with the latest advancements, please visit the Company’s website, aimimmuno.com.
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.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5084607c-f35a-48da-8b06-10fa35de54ff
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com
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