AIM ImmunoTech Details New UPMC Abstract on Completed Clinical Trial Involving Ampligen’s Synergistic Potential in the Treatment of Advanced Recurrent Ovarian Cancer
AIM (NYSE American: AIM) detailed results from a completed Phase 2 trial of intraperitoneal cisplatin + IV pembrolizumab + intraperitoneal Ampligen presented at the 40th SITC Meeting on November 7, 2025. Of 27 enrolled patients (24 evaluable) with platinum-sensitive recurrent ovarian cancer, there were 5 complete responses and 7 partial responses, yielding an objective response rate (ORR) of 50%. The release cites prior pembrolizumab-only ORRs of 7.4% and 9.9% (Keynote-100) for context. The study is listed as ClinicalTrials.gov NCT03734692. AIM also notes U.S., Japan and Netherlands patents on Ampligen combination oncology use, expiring in 2039.
AIM (NYSE American: AIM) ha presentato risultati dettagliati di uno studio di fase 2 completato di cisplatino intraperitoneale + pembrolizumab IV + Ampligen intraperitoneale, durante la 40ª riunione SITC del 7 novembre 2025. Di 27 pazienti arruolati (24 valutabili) con cancro ovarico ricorrente sensibile al platino, sono state 5 risposte complete e 7 risposte parziali, con un tasso di risposta oggettiva (ORR) del 50%. Il comunicato cita ORR precedenti con pembrolizumab da solo di 7,4% e 9,9% (Keynote-100) per fornire contesto. Lo studio è registrato come ClinicalTrials.gov NCT03734692. AIM segnala anche brevetti negli Stati Uniti, in Giappone e nei Paesi Bassi sull'uso combinato di Ampligen in oncologia, che scadranno nel 2039.
AIM (NYSE American: AIM) presentó resultados detallados de un ensayo de fase 2 completado de cisplatino intraperitoneal + pembrolizumab IV + Ampligen intraperitoneal en la 40th SITC Meeting del 7 de noviembre de 2025. De 27 pacientes inscritos (24 evaluables) con cáncer de ovario recidivante sensible al platino, hubo 5 respuestas completas y 7 respuestas parciales, obteniendo una tasa de respuesta objetiva (ORR) del 50%. El comunicado cita ORR anteriores con pembrolizumab solo de 7,4% y 9,9% (Keynote-100) como contexto. El estudio figura como ClinicalTrials.gov NCT03734692. AIM también señala patentes en EE. UU., Japón y Países Bajos sobre el uso combinado de Ampligen en oncología, que expiran en 2039.
AIM (NYSE American: AIM)은 복강 내 시스플라틴 + 정맥 주사 파멜로주맙 + 복강 내 Ampligen 을 병용한 완료된 2상 시험의 상세 결과를 2025년 11월 7일의 40차 SITC 회의에서 발표했습니다. platino에 민감한 재발성 난소암에 대해 27명 등록(24명 평가 가능) 중 5건의 완전 반응과 7건의 부분 반응이 관찰되어 객관적 반응률(ORR) 50%를 달성했습니다. 발표문은 파멜로주맙 단독 ORR를 7.4%와 9.9%로 제시합니다( Keynote-100). 이 연구는 ClinicalTrials.gov NCT03734692로 등재되어 있습니다. AIM은 Ampligen 조합 항암제 사용에 대한 미국, 일본, 네덜란드 특허도 언급하며, 만료년은 2039년입니다.
AIM (NYSE American: AIM) a présenté les résultats détaillés d'un essai de phase 2 terminé associant cisplatine intrapéritonéal + pembrolizumab IV + Ampligen intrapéritonéal lors de la 40e réunion SITC du 7 novembre 2025. Sur 27 patients inclus (24 évaluables) atteints d'un cancer de l'ovaire récurrent sensible au platine, il y a 5 rémissions complètes et 7 rémissions partielles, ce qui donne un taux de réponse objective (ORR) de 50%. Le communiqué cite des ORR antérieures avec pembrolizumab seul de 7,4% et 9,9% (Keynote-100) pour contexte. L'étude est référencée sous ClinicalTrials.gov NCT03734692. AIM note également des brevets aux États-Unis, au Japon et aux Pays-Bas concernant l’utilisation en oncologie de Ampligen en association, expirant en 2039.
AIM (NYSE American: AIM) präsentierte detaillierte Ergebnisse einer abgeschlossenen Phase-2-Studie mit intraperitonealem Cisplatin + intravenösem Pembrolizumab + intraperitonealem Ampligen bei Patienten mit platinempfindlichem rezidivierenden Eierstockkrebs. Die Ergebnisse wurden bei der 40th SITC Meeting am 7. November 2025 vorgestellt. Von 27 eingeschriebenen Patienten (24 auswertbar) gab es 5 komplette Antworten und 7 partielle Antworten, was eine Objektreaktionsrate (ORR) von 50% ergibt. Der Bericht zitiert frühere ORR von Pembrolizumab allein von 7,4% und 9,9% (Keynote-100) zur Einordnung. Die Studie ist registriert unter ClinicalTrials.gov NCT03734692. AIM verweist außerdem auf US-, Japan- und Niederlande-Patente zur kombinierten Nutzung von Ampligen in der Onkologie, die im 2039 auslaufen.
AIM (NYSE American: AIM) قدمت نتائج تفصيلية من تجربة المرحلة الثانية المكتملة للدمج بين سيسبلاتين داخل البطن + بيرموليزوماب عبر الوريد + Ampligen داخل البطن لدى مرضى سرطان المبيض المتكرر الحساس للبلاتين، خلال الاجتماع الأربعين لـ SITC في 7 نوفمبر 2025. من بين 27 مريضاً مسجلاً (24 قابلة للتقييم) يعانون من سرطان مبيض متكرر حساس للبلاتين، كانت هناك 5 استجابات كاملة و7 استجابات جزئية، مما أدى إلى معدل الاستجابة الموضوعية (ORR) 50%. يشير البيان إلى ORR سابقة مع Pembrolizumab وحده بنسب 7.4% و9.9% (Keynote-100) كمرجع. تُدرج الدراسة كـ ClinicalTrials.gov NCT03734692. كما تلاحظ AIM وجود براءات اختراع في الولايات المتحدة واليابان وهولندا لاستخدام Ampligen في علم الأورام بشكل مركب، وتنتهي صلاحيتها في 2039.
- ORR 50% in 24 evaluable patients
- Presented at SITC on Nov 7, 2025
- Patents covering Ampligen combination use expire 2039
- Small trial size: 27 enrolled, 24 evaluable
- Study limited to platinum-sensitive, measurable peritoneal disease, restricting generalizability
Insights
Phase 2 combo therapy shows a notably higher ORR versus pembrolizumab-alone arms, suggesting Ampligen synergy potential.
AIM reported that of 24 evaluable patients, combination locoregional chemoimmunotherapy including Ampligen achieved an Objective Response Rate of
The business mechanism rests on Ampligen acting as a synergistic immune stimulant when paired with checkpoint inhibitors; this claim is supported here by response-rate differences and is strengthened by listed patents expiring in
Concrete items to watch include publication of full trial data and safety tables, duration of response metrics, any regulatory filings or larger randomized studies referenced by the company, and follow-ups presented after the
OCALA, Fla., Nov. 10, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today detailed a recent abstract containing data from the completed Phase 2 advanced recurrent ovarian cancer clinical study utilizing Ampligen (rintatolimod), which was presented at the 40th Annual SITC Meeting on November 7, 2025, at National Harbor, MD.
Platinum-sensitive patients with measurable peritoneal disease were eligible for combination therapy with up to six treatment cycles at 3-week intervals of intraperitoneal cisplatin, intravenous pembrolizumab (also known as Merck’s Keytruda) and intraperitoneal Ampligen. Of the 27 patients included in the trial, 24 were evaluable for response and of those 24 there were 5 patients with complete response and 7 patients with partial response, for an Objective Response Rate (“ORR”) of
Read the full abstract titled “A Phase II Trial of Combination Locoregional Chemoimmunotherapy in Recurrent Platinum-Sensitive Ovarian Cancer Triggers a T Lymphotactic Response Correlating with Clinical Outcomes.”
Read more about the study at ClinicalTrials.gov: NCT03734692
These new ovarian cancer study results are consistent with AIM’s belief that Ampligen can act as a synergistic agent when combined with checkpoint inhibitors. This could be especially encouraging for refractory patients whose cancers do not respond to checkpoint inhibitors alone, such as in the Keynote-189 study in non-small cell lung cancer, which found that approximately
“Ampligen’s demonstrated ability to enhance the effectiveness of traditional cancer treatments could make it a difference maker that dramatically improves tumor immune responses and significantly prolongs the lives of people who have otherwise few effective options for prolonged remission and even possible cure,” said Robert Edwards, MD, Milton Lawrence McCall Professor and Chair, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh School of Medicine.
AIM’s “synergistic” patents include a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody; a patent in Japan (expires December 20, 2039) for the use of Ampligen in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer; and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).
For more information about the SITC Annual Meeting, please visit sitcancer.org.
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 for any indication. 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
What were the key results for AIM (AIM) from the Nov 7, 2025 SITC presentation?
How does AIM’s Ampligen combination ORR compare to pembrolizumab alone in prior studies?
Which clinical trial identifier covers AIM’s ovarian cancer study?
When were AIM’s ovarian cancer results presented and where?
Do patents protect AIM’s Ampligen combination oncology approach and when do they expire?
What are limitations investors should note about the AIM Phase 2 ovarian study?
