AIM ImmunoTech Reports Positive Preliminary Data in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic Cancer
AIM ImmunoTech (NYSE American: AIM) reported positive preliminary data from its Phase 1b/2 study of Ampligen and Imfinzi combination therapy for late-stage pancreatic cancer. The study showed stable disease in two out of three patients at 6 months in the first subject cohort. The combination therapy was generally well-tolerated with no severe adverse events. In the second cohort, two of three subjects also have stable disease, though not yet at the 6-month mark. Prof. Casper H.J. van Eijck noted improvements in quality of life and no toxicity, comparing favorably to typical disease progression rates. The data suggests Ampligen's potential synergy with checkpoint inhibitors for treating late-stage pancreatic cancer.
AIM ImmunoTech (NYSE American: AIM) ha riportato dati preliminari positivi dal suo studio di Fase 1b/2 sulla terapia combinata di Ampligen e Imfinzi per il cancro pancreatico avanzato. Lo studio ha dimostrato una malattia stabile in due su tre pazienti dopo 6 mesi nel primo gruppo di soggetti. La terapia combinata è stata generalmente ben tollerata senza eventi avversi gravi. Nel secondo gruppo, anche due su tre soggetti presentano una malattia stabile, sebbene non ancora al segno dei 6 mesi. Il Prof. Casper H.J. van Eijck ha notato miglioramenti nella qualità della vita e assenza di tossicità, confrontandosi favorevolmente con le tipiche velocità di progressione della malattia. I dati suggeriscono il potenziale sinergico di Ampligen con gli inibitori del checkpoint per il trattamento del cancro pancreatico avanzato.
AIM ImmunoTech (NYSE American: AIM) informó sobre datos preliminares positivos de su estudio de Fase 1b/2 de terapia combinada de Ampligen e Imfinzi para el cáncer de páncreas en etapas avanzadas. El estudio mostró enfermedad estable en dos de tres pacientes a los 6 meses en la primera cohorte de sujetos. La terapia combinada fue generalmente bien tolerada sin eventos adversos graves. En la segunda cohorte, dos de tres sujetos también tienen enfermedad estable, aunque aún no en el límite de 6 meses. El Prof. Casper H.J. van Eijck observó mejoras en la calidad de vida y ausencia de toxicidad, comparándose favorablemente con las tasas típicas de progresión de la enfermedad. Los datos sugieren el potencial sinérgico de Ampligen con los inhibidores de checkpoints para el tratamiento del cáncer de páncreas en etapas avanzadas.
AIM ImmunoTech (NYSE American: AIM)은 긍정적인 초기 데이터를 발표했습니다. 이는 말기 췌장암에 대한 Ampligen과 Imfinzi 조합 요법의 1b/2상 연구에서 나온 결과입니다. 연구에 따르면 첫 번째 대조군에서 6개월 동안 3명 중 2명에서 질병이 안정적이었다고 합니다. 조합 요법은 대체로 잘 견딜 수 있었으며 심각한 부작용은 없었습니다. 두 번째 대조군에서도 3명 중 2명이 안정적이지만, 6개월 기준에는 아직 도달하지 않았습니다. Casper H.J. van Eijck 교수는 삶의 질 개선과 독성 없는 상태를 언급하며, 일반적인 질병 진행 속도와 비교하여 유리하다고 전했습니다. 데이터는 Ampligen이 체크포인트 억제제들과의 잠재적 시너지를 가진다는 것을 시사합니다 말기 췌장암 치료를 위해.
AIM ImmunoTech (NYSE American: AIM) a rapporté des données préliminaires positives de son étude de Phase 1b/2 sur la thérapie combinée d'Ampligen et d'Imfinzi pour le cancer du pancréas à un stade avancé. L'étude a montré une stabilisation de la maladie chez deux des trois patients après 6 mois dans le premier groupe de sujets. La thérapie combinée a été généralement bien tolérée sans événements indésirables graves. Dans le second groupe, deux des trois sujets présentent également une maladie stable, bien que cela ne soit pas encore le cas à 6 mois. Le Prof. Casper H.J. van Eijck a noté des améliorations de la qualité de vie et aucune toxicité, se comparant favorablement aux taux de progression typiques de la maladie. Les données suggèrent le potentiel de synergie d'Ampligen avec les inhibiteurs de points de contrôle pour traiter le cancer du pancréas à un stade avancé.
AIM ImmunoTech (NYSE American: AIM) berichtete über positive vorläufige Daten aus seiner Phase 1b/2-Studie zur Kombinationstherapie mit Ampligen und Imfinzi für fortgeschrittenen Bauchspeicheldrüsenkrebs. Die Studie ergab eine stabile Erkrankung bei zwei von drei Patienten nach 6 Monaten in der ersten Patientenkohorte. Die Kombinationstherapie war im Allgemeinen gut verträglich und wies keine schweren unerwünschten Ereignisse auf. In der zweiten Kohorte haben ebenfalls zwei von drei Patienten eine stabile Erkrankung, jedoch noch nicht zum 6-Monats-Zeitraum. Prof. Casper H.J. van Eijck bemerkte Verbesserungen der Lebensqualität und keine Toxizität, was sich im Vergleich zu typischen Krankheitsverlaufsgeschwindigkeiten positiv auswirkt. Die Daten deuten auf das potenzielle Synergiepotential von Ampligen mit Checkpoint-Inhibitoren zur Behandlung von fortgeschrittenem Bauchspeicheldrüsenkrebs hin.
- Stable disease observed in 2 out of 3 patients at 6 months in the first cohort
- Combination therapy generally well-tolerated with no severe adverse events
- 2 out of 3 patients in the second cohort also show stable disease
- Improvements in quality of life reported by the study's Coordinating Investigator
- Potential synergy demonstrated between Ampligen and checkpoint inhibitors
- Data is still preliminary and based on a small sample size
- Unable to report on progression-free survival (PFS) yet due to disease progression
The preliminary data from the Phase 1b/2 DURIPANC study shows promising results for AIM ImmunoTech's Ampligen in combination with AstraZeneca's Imfinzi for late-stage pancreatic cancer. Two out of three patients in the first cohort maintained stable disease at 6 months, which is significant given that 80% of similar patients typically progress within 3 months. The therapy appears well-tolerated with no severe adverse events.
While it's too early to calculate median progression-free survival (PFS), the stability rate of
The combination of Ampligen (a TLR-3 agonist) and Imfinzi (an anti-PD-L1 immune checkpoint inhibitor) represents an innovative approach in treating late-stage pancreatic cancer. The observed stability in patients at 6 months is particularly noteworthy, as pancreatic cancer is notoriously aggressive with poor prognosis. The lack of severe toxicity is also crucial, as it allows for prolonged treatment.
The reported changes in immune infiltration into metastatic lesions suggest that this combination may be effectively modulating the tumor microenvironment. This could potentially lead to more durable responses or even complete responses in some patients. However, we must remain cautious until we see results from larger cohorts and longer follow-up periods. The potential for this combination to improve both survival and quality of life in this difficult-to-treat cancer is certainly worth further investigation.
This preliminary data represents a potential breakthrough for AIM ImmunoTech (NYSE: AIM) in the lucrative oncology market. Late-stage pancreatic cancer has treatment options and any therapy showing promise could capture significant market share. The collaboration with AstraZeneca, a pharmaceutical giant, adds credibility and potential for future partnerships.
However, investors should note that this is early-stage data from a small sample size. The path to market approval is long and uncertain. AIM's financial position will be important to fund further trials. As of their last report, AIM had
Preliminary finding of stable disease in two out of three patients at 6 months in the first subject cohort
Combination of Ampligen and Imfinzi continues to be generally well-tolerated with no severe adverse events or dose-limiting toxicities
OCALA, Fla., Sept. 19, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced positive preliminary data from the Phase 1b/2 study (“DURIPANC”) evaluating the combination of AIM’s Ampligen® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer.
DURIPANC is an investigator-initiated, exploratory, open-label, single-center study. AIM previously announced that investigators at Erasmus Medical Center (“Erasmus MC”) in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM is pleased to announce that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival (“PFS”) requires that
Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects.
Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and Coordinating Investigator for the DURIPANC study, commented: “First of all, we have observed improvements in quality of life and we saw no toxicity at all — with ‘quality of life’ recognized as an indicator of stable disease. As a comparison, approximately
“Ampligen continues to demonstrate its synergistic potential as a combination therapy with checkpoint inhibitors and these data — following the positive data from the Dutch-government approved Early Access Program — underscore Ampligen’s potential for the treatment of late-stage pancreatic cancer, where there remains a significant and lethal unmet need,” commented AIM Chief Executive Officer Thomas K. Equels.
Read more at ClinicalTrials.gov NCT05927142 — “Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect”
Learn more about the clinical collaboration between AIM, AstraZeneca and Erasmus MC.
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 does not guarantee that Ampligen will be approved as a combination therapy for late-stage 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.
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