Erasmus Medical Center Safety Committee Grants Approval to Proceed with Phase 2 Study of Ampligen® and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic Cancer
AIM ImmunoTech (NYSE American: AIM) has received Safety Committee approval to advance to Phase 2 of their Phase 1b/2 clinical trial studying the combination of Ampligen® and Imfinzi® for late-stage pancreatic cancer treatment. The approval follows positive Phase 1 safety data showing the combination therapy was generally well-tolerated with no severe treatment-related adverse events.
The DURIPANC study, conducted at Erasmus Medical Center in the Netherlands, will enroll up to 25 patients in Phase 2, including six patients from Phase 1. Early observations indicate improvements in quality of life, with some patients showing stable disease for 15+ months after starting FOLFIRINOX treatment. This is notable considering approximately 80% of similar patients at Erasmus MC typically show disease progression after three months without this treatment.
The study aims to address a significant unmet need in oncology, as pancreatic cancer claims approximately 50,000 American lives annually with currently no effective therapy available.
AIM ImmunoTech (NYSE American: AIM) ha ricevuto l'approvazione del Comitato di Sicurezza per avanzare alla Fase 2 del loro studio clinico di Fase 1b/2 che esamina la combinazione di Ampligen® e Imfinzi® per il trattamento del cancro pancreatico in fase avanzata. L'approvazione segue dati positivi di sicurezza della Fase 1 che mostrano che la terapia combinata è stata generalmente ben tollerata, senza gravi eventi avversi correlati al trattamento.
Lo studio DURIPANC, condotto presso l'Erasmus Medical Center nei Paesi Bassi, arruolerà fino a 25 pazienti nella Fase 2, inclusi sei pazienti provenienti dalla Fase 1. Le osservazioni preliminari indicano miglioramenti nella qualità della vita, con alcuni pazienti che mostrano malattia stabile per oltre 15 mesi dopo l'inizio del trattamento con FOLFIRINOX. Questo è notevole considerando che circa l'80% di pazienti simili all'Erasmus MC normalmente mostrano progressione della malattia dopo tre mesi senza questo trattamento.
Lo studio mira a soddisfare un importante bisogno non soddisfatto in oncologia, poiché il cancro pancreatico causa circa 50.000 morti americane ogni anno, senza alcuna terapia efficace attualmente disponibile.
AIM ImmunoTech (NYSE American: AIM) ha recibido la aprobación del Comité de Seguridad para avanzar a la Fase 2 de su ensayo clínico de Fase 1b/2 que estudia la combinación de Ampligen® e Imfinzi® en el tratamiento del cáncer de páncreas en etapa avanzada. La aprobación sigue a datos positivos de seguridad de la Fase 1 que mostraron que la terapia combinada fue en general bien tolerada, sin eventos adversos graves relacionados con el tratamiento.
El estudio DURIPANC, realizado en el Erasmus Medical Center en los Países Bajos, inscribirá hasta 25 pacientes en la Fase 2, incluidos seis pacientes de la Fase 1. Las observaciones iniciales indican mejoras en la calidad de vida, con algunos pacientes mostrando enfermedad estable durante más de 15 meses después de comenzar el tratamiento con FOLFIRINOX. Esto es notable considerando que aproximadamente el 80% de pacientes similares en Erasmus MC normalmente muestran progresión de la enfermedad después de tres meses sin este tratamiento.
El estudio tiene como objetivo abordar una necesidad no satisfecha importante en oncología, ya que el cáncer de páncreas causa aproximadamente 50,000 muertes americanas anualmente y actualmente no hay terapia efectiva disponible.
AIM ImmunoTech (NYSE American: AIM)은 췌장암 말기 치료를 위한 Ampligen®과 Imfinzi®의 조합을 연구하는 1b/2상 임상 시험의 2상으로 진행하기 위해 안전성 위원회의 승인을 받았습니다. 승인은 조합 요법이 일반적으로 잘 견디며 심각한 치료 관련 부작용이 없다는 긍정적인 1상 안전성 데이터를 바탕으로 이루어졌습니다.
네덜란드 에라스무스 의과대학에서 실시되는 DURIPANC 연구는 2상에서 최대 25명의 환자를 등록하며, 이 중 6명은 1상 환자입니다. 초기 관찰 결과, 일부 환자가 FOLFIRINOX 치료를 시작한 후 15개월 이상 동안 병이 안정적으로 유지되면서 삶의 질 개선이 나타났습니다. 이는 에라스무스 MC의 유사한 환자의 약 80%가 이 치료 없이 3개월 후에 질병이 진행되는 것을 고려할 때 주목할 만합니다.
이 연구는 매년 약 50,000명의 미국인 생명을 앗아가는 췌장암 분야의 중대한 충족되지 않은 필요를 해결하려 하고 있으며, 현재 효과적인 치료법이 없습니다.
AIM ImmunoTech (NYSE American: AIM) a reçu l'approbation du Comité de Sécurité pour passer à la Phase 2 de son essai clinique de Phase 1b/2, qui étudie la combinaison de Ampligen® et Imfinzi® pour le traitement du cancer du pancréas à un stade avancé. Cette approbation fait suite à des données de sécurité positives de la Phase 1 montrant que la thérapie combinée a été généralement bien tolérée, sans événements indésirables graves liés au traitement.
L'étude DURIPANC, réalisée au Erasmus Medical Center aux Pays-Bas, recrutera jusqu'à 25 patients en Phase 2, y compris six patients de la Phase 1. Les premières observations indiquent des améliorations de la qualité de vie, certains patients montrant une maladie stable pendant plus de 15 mois après le début du traitement par FOLFIRINOX. Cela est remarquable, compte tenu du fait qu'environ 80 % des patients similaires à l'Erasmus MC montrent généralement une progression de la maladie après trois mois sans ce traitement.
L'étude vise à répondre à un besoin non satisfait significatif en oncologie, le cancer du pancréas entraînant environ 50 000 décès américains chaque année sans traitement efficace actuellement disponible.
AIM ImmunoTech (NYSE American: AIM) hat die Genehmigung des Sicherheitsteams erhalten, um in Phase 2 ihrer Phase 1b/2 klinischen Studie über die Kombination von Ampligen® und Imfinzi® zur Behandlung von spätstadialem Bauchspeicheldrüsenkrebs vorzurücken. Die Genehmigung folgt auf positive Sicherheitsdaten aus Phase 1, die zeigen, dass die Kombinationstherapie im Allgemeinen gut vertragen wurde und keine schweren behandlungsbedingten unerwünschten Ereignisse auftraten.
Die DURIPANC-Studie, die am Erasmus Medical Center in den Niederlanden durchgeführt wird, wird in Phase 2 bis zu 25 Patienten einschließen, darunter sechs Patienten aus Phase 1. Erste Beobachtungen deuten auf Verbesserungen der Lebensqualität hin, wobei einige Patienten nach Beginn der FOLFIRINOX-Behandlung über 15 Monate stabile Erkrankung zeigen. Dies ist bemerkenswert, da etwa 80 % ähnlicher Patienten am Erasmus MC in der Regel nach drei Monaten ohne diese Behandlung eine Krankheitsprogression zeigen.
Die Studie zielt darauf ab, ein signifikantes unbefriedigtes Bedürfnis in der Onkologie zu adressieren, da Bauchspeicheldrüsenkrebs jährlich etwa 50.000 amerikanische Leben fordert und derzeit keine wirksame Therapie verfügbar ist.
- Phase 1 safety data showed no severe treatment-related adverse events
- Some patients demonstrated stable disease for 15+ months after treatment
- Quality of life improvements observed in treated patients
- Safety Committee approval received to proceed to Phase 2
- None.
Insights
The advancement to Phase 2 for AIM ImmunoTech's combination therapy trial marks a significant milestone in addressing one of oncology's most challenging indications. Pancreatic cancer, with its 50,000 annual fatalities in the US alone, represents a substantial market opportunity, currently lacking effective treatment options.
The safety profile demonstrated in Phase 1 is particularly encouraging. The absence of severe adverse events or dose-limiting toxicities is important for late-stage cancer treatments, where quality of life considerations are paramount. This positive safety data reduces the risk profile for future development stages and potential commercialization.
The preliminary efficacy signals are noteworthy: stable disease in patients beyond the typical three-month progression window observed in 80% of similar cases at Erasmus MC. While early, this data suggests potential therapeutic value, especially considering some patients maintaining stable disease for 15+ months post-FOLFIRINOX treatment.
The study's comprehensive biomarker analysis approach, including blood samples and tumor biopsies, could provide valuable insights into the therapy's mechanism of action and patient response patterns. This data could be instrumental in identifying optimal patient populations and potentially supporting future regulatory submissions.
For investors, key considerations include:
- The partnership with AstraZeneca adds credibility and potential commercialization capabilities
- The expansion to Phase 2 with up to 25 patients could provide more definitive efficacy signals
- The unmet medical need in pancreatic cancer presents a significant market opportunity
- The comprehensive biomarker analysis could enhance the therapy's value proposition
Safety Committee approval based on positive Phase 1 safety data demonstrating the combination therapy to be generally well-tolerated with no severe treatment-related adverse events or dose-limiting toxicities
Enrollment for Phase 2 expected to commence imminently
OCALA, Fla., Feb. 05, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced Safety Committee approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM’s Ampligen® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”).
DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at the Erasmus Medical Center (“Erasmus MC”). The approval to proceed to Phase 2 was granted following the Safety Committee’s review of the complete Phase 1 safety data, which found the combination therapy to be generally well-tolerated with no treatment-related severe adverse events or dose-limiting toxicities.
AIM CEO Thomas K. Equels stated: “Patients with late-stage pancreatic cancer have very few options. This is a lethal malignancy that kills approximately 50,000 Americans every year and there is no effective therapy. It is one of the highest unmet needs in oncology, and we are excited to see this clinical study at Erasmus Medical Center in the Netherlands move to Phase 2. Ampligen is believed to reprogram the immune system to enhance the cellular response, and this combination study with Imfinzi is part of our broader strategy to explore these effects in combination with synergistic anti-cancer agents, including checkpoint inhibitors.”
Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and Coordinating Investigator for the DURIPANC study, commented: “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
Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC. Six patients from Phase 1 will be included in Phase 2, as per the protocol and based on their Phase 1 participation. Continued enrollment is expected to begin soon.
Read more at about DURIPANC 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 efficacy (DURIPANC)“
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 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.
FAQ
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