AIM ImmunoTech announces a planned follow-up clinical study evaluating a combination treatment of AIM’s Ampligen® and AstraZeneca’s FluMist® to address the recent avian influenza outbreaks
AIM ImmunoTech (NYSE American: AIM) has announced plans to advance Ampligen as a vaccine adjuvant for avian influenza. The company will conduct a follow-up clinical study combining Ampligen with AstraZeneca's FluMist nasal spray vaccine. This initiative builds on previous research at the University of Alabama-Birmingham, which showed that intranasal Ampligen administration after FluMist increased immune response by over four-fold and induced cross-reactive antibodies against highly pathogenic avian influenza strains H5N1, H7N9, and H7N3.
Pre-clinical studies demonstrated significant protective effects, with 50-100% survival rates against various H5N1 strains in mice. Non-human primate studies showed protection against H5N1 symptoms and generated neutralizing antibodies. Previous human trials indicated that intranasal Ampligen was generally well-tolerated with no serious treatment-related adverse events.
AIM ImmunoTech (NYSE American: AIM) ha annunciato piani per avanzare Ampligen come adiuvante vaccinale per l'influenza aviaria. L'azienda condurrà uno studio clinico di follow-up combinando Ampligen con il vaccino spray nasale FluMist di AstraZeneca. Questa iniziativa si basa su precedenti ricerche condotte all'Università dell'Alabama-Birmingham, che hanno dimostrato che la somministrazione intranasale di Ampligen dopo FluMist ha aumentato la risposta immunitaria di oltre quattro volte e ha indotto anticorpi cross-reattivi contro ceppi altamente patogeni di influenza aviaria H5N1, H7N9 e H7N3.
Studi preclinici hanno dimostrato effetti protettivi significativi, con tassi di sopravvivenza del 50-100% contro vari ceppi di H5N1 nei topi. Studi su primati non umani hanno mostrato protezione contro i sintomi di H5N1 e hanno generato anticorpi neutralizzanti. Precedenti sperimentazioni umane hanno indicato che l'Ampligen intranasale era generalmente ben tollerato, senza eventi avversi seri attribuibili al trattamento.
AIM ImmunoTech (NYSE American: AIM) ha anunciado planes para avanzar Ampligen como un adyuvante de vacuna para la gripe aviar. La empresa llevará a cabo un estudio clínico de seguimiento combinando Ampligen con la vacuna en spray nasal FluMist de AstraZeneca. Esta iniciativa se basa en investigaciones anteriores en la Universidad de Alabama-Birmingham, que mostraron que la administración intranasal de Ampligen después de FluMist aumentó la respuesta inmunitaria más de cuatro veces e indujo anticuerpos cruzados reactivos contra cepas altamente patógenas de gripe aviar H5N1, H7N9 y H7N3.
Los estudios preclínicos demostraron efectos protectores significativos, con tasas de supervivencia del 50-100% contra varias cepas de H5N1 en ratones. Los estudios en primates no humanos mostraron protección contra los síntomas de H5N1 y generaron anticuerpos neutralizantes. Ensayos humanos anteriores indicaron que Ampligen intranasal fue generalmente bien tolerado sin eventos adversos serios relacionados con el tratamiento.
AIM ImmunoTech (NYSE American: AIM)은 조류 인플루엔자 백신 보조제로서 Ampligen을 발전시킬 계획을 발표했습니다. 이 회사는 AstraZeneca의 비강 스프레이 백신 FluMist와 Ampligen을 결합하는 후속 임상 연구를 수행할 것입니다. 이 이니셔티브는 앨라배마-버밍엄 대학교에서 실시된 이전 연구를 기반으로 하며, FluMist 이후의 비강 내 Ampligen 투여가 면역 반응을 4배 이상 증가시키고 H5N1, H7N9, H7N3와 같은 고병원성 조류 인플루엔자 균주에 대한 교차 반응성 항체를 유도했음을 보여주었습니다.
전임상 연구에서는 다양한 H5N1 균주에 대해 50-100%의 생존율이 관찰되었으며, 비인간 영장류 연구에서는 H5N1 증상에 대한 보호 효과와 중화 항체 생성을 보여주었습니다. 이전의 인간 임상 시험에서는 비강 내 Ampligen이 일반적으로 잘 견뎌졌으며, 치료와 관련된 심각한 부작용이 없음을 나타냈습니다.
AIM ImmunoTech (NYSE American: AIM) a annoncé des projets de développement de Ampligen en tant qu'adjuvant vaccinal contre la grippe aviaire. L'entreprise mènera une étude clinique de suivi associant Ampligen au vaccin en spray nasal FluMist d'AstraZeneca. Cette initiative s'appuie sur des recherches antérieures menées à l'Université de l'Alabama à Birmingham, qui ont montré que l'administration intranasale d'Ampligen après FluMist augmentait la réponse immunitaire de plus de quatre fois et induisait des anticorps croisés réactifs contre des souches hautement pathogènes de grippe aviaire H5N1, H7N9 et H7N3.
Des études précliniques ont démontré des effets protecteurs significatifs, avec des taux de survie de 50 à 100 % contre diverses souches H5N1 chez les souris. Des études sur des primates non humains ont montré une protection contre les symptômes de H5N1 et ont généré des anticorps neutralisants. Des essais humains antérieurs ont indiqué que l'Ampligen intranasal était généralement bien toléré et qu'aucun événement indésirable grave lié au traitement n'a été observé.
AIM ImmunoTech (NYSE American: AIM) hat Pläne angekündigt, Ampligen als Impfstoffadjuvans gegen die Vogelgrippe weiterzuentwickeln. Das Unternehmen wird eine Nachfolgestudie durchführen, die Ampligen mit dem Nasenspray-Impfstoff FluMist von AstraZeneca kombiniert. Diese Initiative basiert auf früheren Forschungen an der University of Alabama-Birmingham, die gezeigt haben, dass die intranasale Verabreichung von Ampligen nach FluMist die Immunreaktion um mehr als das Vierfache erhöhte und kreuzreaktive Antikörper gegen hochpathogene Vogelgrippe-Stämme H5N1, H7N9 und H7N3 induzierte.
Präklinische Studien zeigten signifikante schützende Effekte mit Überlebensraten von 50-100 % gegen verschiedene H5N1-Stämme bei Mäusen. Studien an nichtmenschlichen Primaten zeigten Schutz gegen H5N1-Symptome und erzeugten neutralisierende Antikörper. Frühere Humanversuche zeigten, dass intranasales Ampligen im Allgemeinen gut vertragen wurde und keine schwerwiegenden behandlungsbedingten unerwünschten Ereignisse auftraten.
- Previous clinical trials showed 4x increased immune response when combining Ampligen with FluMist
- Pre-clinical studies demonstrated 50-100% survival protection against H5N1 strains
- Non-human primate studies showed protection against H5N1 symptoms
- Human safety trials showed Ampligen was well-tolerated with no serious adverse events
- Company seeking external grants to fund the study, indicating potential financial constraints
- Additional clinical trials required before potential commercialization
Insights
The planned clinical study combining Ampligen with FluMist represents a potentially significant advancement in addressing the growing threat of avian influenza. The previous UAB study's results are particularly noteworthy, demonstrating a greater than
The pre-clinical data presents compelling evidence of efficacy:
- Mouse studies showed
50-100% survival rates against various H5N1 strains - Non-human primate trials demonstrated protection against lung fibrosis and death
- Generation of neutralizing antibodies against multiple H5N1 strains indicates broad-spectrum protection potential
The intranasal delivery method represents a significant advantage in terms of administration simplicity and potential market adoption. The engagement of Amarex as CRO and the pursuit of government and industry grants suggests a well-structured development strategy that could help mitigate financial risks while accelerating development.
The company's focus on collaborative grants is particularly strategic given the current market cap of approximately
Planned Investigational New Drug application to expand on previous clinical work at the University of Alabama-Birmingham in which administration of Ampligen as an intranasal adjuvant increased immune response, including cross-protection via avian influenza antibody generation in humans
OCALA, Fla., Feb. 07, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced its initiation of a plan to advance Ampligen as a vaccine adjuvant for avian influenza as part of the Company’s antiviral priority development pipeline.
AIM has engaged Amarex Clinical Research (“Amarex”), its Clinical Research Organization (“CRO”), with the application and eventual management of a follow-up Investigational New Drug (“IND”) application for the study of a potential avian influenza combination therapy of AIM’s Ampligen and AstraZeneca’s FluMist, a nasal spray vaccine that helps prevent seasonal influenza. AIM is seeking collaborative grants from government and industry to defray the cost of the study.
The new proposed clinical trial would expand upon previous Company-sponsored clinical research at the University of Alabama-Birmingham (“UAB”) (Overton 2014), which indicated that intranasal delivery of Ampligen after the intranasal delivery of the FluMist seasonal influenza vaccine not only increased the immune response to seasonal variants in the vaccine by greater than four-fold, but most importantly induced cross-reactive secretory Immunoglobulin A against highly pathogenic avian influenza virus strains H5N1, H7N9 and H7N3.
See ClinicalTrials.gov: NCT01591473 – “Safety Study of FluMist With and Without Ampligen”
AIM CEO Thomas K. Equels stated: “The avian flu has emerged as a serious and ever-growing public health threat. We believe there is the potential for an influenza vaccination program that provides broader coverage than the currently approved vaccination programs, with the added simplicity of being delivered intranasally. Specifically, there is already both pre-clinical and clinical data which demonstrates potential for synergy between our lead compound Ampligen to provide greater efficacy and potential epitope spreading and cross-reactivity for avian influenza when combined with AstraZeneca’s FluMist vaccine. Based on the UAB clinical data to date, we believe such a combination therapy could also be an effective barrier against avian flu infections.”
This Company’s belief stems directly from the pre-clinical and clinical work performed with Ampligen and multiple influenza variants, some of which supported the conception of the original UAB study.
- Previous pre-clinical work showed that when Ampligen was administered with the then-standard seasonal trivalent flu vaccine — which included influenza A H1N1, influenza A H3N2 and influenza B Shanghai strain — intranasally to laboratory mice, it manifested cross-reactivity of mucosal and serum antibodies against H5N1. Furthermore, to demonstrate whether the H5N1 antibodies generated by intranasal Ampligen combined with intranasal vaccine conferred immunity to H5N1, mice were challenged with three H5N1 variants 14 days after final inoculation. At 14 days post H5N1 challenge,
50% survival protection from influenza A Vietnam strain compared to0% in uninoculated mice was observed and100% survival from influenza A Hong Kong strain and influenza A Indonesia strain viruses, compared to60% and20% respectively in naïve controls. - Intranasal delivery of Ampligen in combination with NIBRG14 H5N1 vaccine conferred serum and mucosal antibodies and protected non-human primates from H5N1 symptoms, including lung fibrosis (scarring) and death, when challenged with the homologous H5N1 pathogen. In addition, it also provided neutralizing antibodies against other H5N1 strains, indicating that the intranasal immunization with the Ampligen-combined influenza A H5N1 vaccine can provide non-human primates with cross-protective immunity against influenza A H5N1 virus challenge.
- An AIM-sponsored study to assess the safety, tolerability and biological activity of intranasal Ampligen in humans found that repeated administration in four cohorts of 10 subjects each was generally well-tolerated with no serious treatment-related adverse events.
AIM believes that the totality of this pre-clinical and clinical work to date — combined with the ever-growing threat of Avian influenza — strongly supports its decision to move forward with this second Ampligen and FluMist study in humans.
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 or vaccine adjuvant for any variant of influenza. 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
What are the key findings from AIM's previous Ampligen and FluMist combination study?
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